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    Clinical Trial Results:
    Skeletal muscle-derived cell implantation in female patients with stress urinary incontinence: a multicenter, randomized, parallel-group, placebo-controlled clinical study

    Summary
    EudraCT number
    		 2009-011797-15
    Trial protocol
    		 DE   CZ   BG   PL  
    Global end of trial date
    08 Jun 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2026
    First version publication date
    02 Apr 2026
    Other versions
    Summary report(s)
    		 Implantation of Autologous Skeletal Muscle‑Derived Cells Combined with Electrical Stimulation in Patients with Stress Urinary Incontinence

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IC-01-01-4-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Innovacell Biotechnologie AG
    Sponsor organisation address
    Mitterweg 24, Innsbruck, Austria, 6020
    Public contact
    Clinical Department Innovacell, Innovacell Biotechnologie AG, office@innovacell.com
    Scientific contact
    Clinical Department Innovacell, Innovacell Biotechnologie AG, office@innovacell.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Dec 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to find the optimal cell count for functional regeneration of the urethral sphincter including safety evaluation stress urinary incontinence.
    Protection of trial subjects
    The rights, safety, and well-being of trial participants are the primary considerations of this clinical trial and prevail over interests of science and society. The trial is conducted in full accordance with the International Conference of Harmonisation Good Clinical Practice (GCP), the Declaration of Helsinki, and applicable national and local laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 208
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Romania: 79
    Country: Number of subjects enrolled
    Czechia: 9
    Worldwide total number of subjects
    319
    EEA total number of subjects
    319
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    222
    From 65 to 84 years
    97
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment of patients per site was not limited and was competitive across countries (4) and sites (32). Study recruitment started in June 2010 and was planned to last 8 months.

    Pre-assignment
    Screening details
    		 In total, 319 patients were screened and 263 of them were randomized in 4 treatment goups in a ratio 2:2:2:1. 227 were included in the safety data set and 217 patients were final considered as the intention-to-treat (ITT) population.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Patients were randomized in an open manner to cell implantation or control groups and in a double-blind mannerto: a) high or low cell count implantation, and b) to duloxetine or duloxetine-placebo treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Low Cell Count (CL1)
    Arm description
    		 In this arm 0.2 x 10e6 autologous skeletal muscle-derived cells (Low Cell Count) are implanted in female patients with stress urinary incontinence.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Autologous skeletal muscle-derived cells
    Investigational medicinal product code
    Other name
    ICES13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    The IMP containing either 0.2 x 10e6 cells (Low Cell Count) or 10 x 10e6 (High Cell Count) in cell transport medium and is stored in 3 cryovials (1ml/vial). Prior to implantation, the IMP is prepared and thawed by the addition of 1ml Ringer's lactate solution per vial. The single administration of the IMP is performed via a standardized ultrasound-directed transurethral injection.

    Arm title
    		 High cell count (CL2)
    Arm description
    		 In this arm 10 x 10e6 autologous skeletal muscle-derived cells (Low Cell Count) are implanted in female patients with stress urinary incontinence.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SMDC
    Investigational medicinal product code
    Other name
    ICES13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    The IMP containing either 0.2 x 10e6 cells (Low Cell Count) or 10 x 10e6 (High Cell Count) in cell transport medium and is stored in 3 cryovials (1ml/vial). Prior to implantation, the IMP is prepared and thawed by the addition of 1ml Ringer's lactate solution per vial. The single administration of the IMP is performed via a standardized ultrasound-directed transurethral injection.

    Arm title
    		 Duloxetine-placebo (C1)
    Arm description
    		 Placebo (for Duloxetine arm)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    M0938C/CPS1/10A
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules in identical shape and appearance to duloxetine, applied in the same manner as the active control.

    Arm title
    		 Duloxetine (C2)
    Arm description
    		 Duloxetine with increasing concentration over the weeks of application was administered in this arm
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Duloxetine
    Investigational medicinal product code
    A702141/CPS1/10A
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20mg/d duloxetine was applied for week one with an increasing dose of 20 mg/d to maximal 80 mg/d. The highest tolerated dosage was applied for 12 weeks. Further down titration of the medication was done for 2 weeks (50% reduction/ week).

    Number of subjects in period 1 [1]
    		Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Started
    64
    56
    72
    35
    Completed
    61
    56
    68
    32
    Not completed
    3
    0
    4
    3
         Lost to follow-up
    3
    -
    4
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: From the overall enrolled 319 patients, 56 patients were not randomized and therefore were excluded from the trial. Out of 263 randomized patients, 36 were not exposed to any trial treatment, thus comprising a safety analysis set of 227 patients. 10 patients of the safety set were not eligible and were therefore excluded from the ITT analysis.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Low Cell Count (CL1)
    Reporting group description
    		 In this arm 0.2 x 10e6 autologous skeletal muscle-derived cells (Low Cell Count) are implanted in female patients with stress urinary incontinence.

    Reporting group title
    High cell count (CL2)
    Reporting group description
    		 In this arm 10 x 10e6 autologous skeletal muscle-derived cells (Low Cell Count) are implanted in female patients with stress urinary incontinence.

    Reporting group title
    Duloxetine-placebo (C1)
    Reporting group description
    		 Placebo (for Duloxetine arm)

    Reporting group title
    Duloxetine (C2)
    Reporting group description
    		 Duloxetine with increasing concentration over the weeks of application was administered in this arm

    Reporting group values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2) Total
    Number of subjects
    		 64 56 72 35 227
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.4 ( 13.1 ) 55.2 ( 11.1 ) 58.1 ( 11.7 ) 61.6 ( 11.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 64 56 72 35 227
        Male
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Low Cell Count (CL1)
    Reporting group description
    		 In this arm 0.2 x 10e6 autologous skeletal muscle-derived cells (Low Cell Count) are implanted in female patients with stress urinary incontinence.

    Reporting group title
    High cell count (CL2)
    Reporting group description
    		 In this arm 10 x 10e6 autologous skeletal muscle-derived cells (Low Cell Count) are implanted in female patients with stress urinary incontinence.

    Reporting group title
    Duloxetine-placebo (C1)
    Reporting group description
    		 Placebo (for Duloxetine arm)

    Reporting group title
    Duloxetine (C2)
    Reporting group description
    		 Duloxetine with increasing concentration over the weeks of application was administered in this arm

    Primary: Change of IEF of Visit 2 from baseline (Visit -5)

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    End point title
    		 Change of IEF of Visit 2 from baseline (Visit -5)
    End point description
    The frequency of incontinence episodes were documented by a bowel diary that was completed by the patient. In this study, the frequency of incontinence episodes was calculated as the number of incontinence episodes over 7 days.
    End point type
    Primary
    End point timeframe
    Changes in IEF at Visit 2 (42 days post implantation) compared to baseline Visit -5 (49 days prior implantation) in each treatment group.
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    61
    56
    68
    32
    Units: IEF change
        arithmetic mean (standard deviation)
    -15.5 ( 12 )
    -15.7 ( 17.5 )
    -8.6 ( 10.7 )
    -12.1 ( 12.4 )
    Statistical analysis title
    		 High Cell Count (CL2) vs. Placebo (C1)
    Statistical analysis description
    The treatment groups were tested by using a two-sided t-test for the hypotheses and two-sided parametric confidence intervals. A sequentially rejective multiple test procedure on a family-wise error rate of α_global = 0.05 was used.
    Comparison groups
    High cell count (CL2) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0097
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Low Cell Count (CL1) vs. Placebo (C1)
    Comparison groups
    Low Cell Count (CL1) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0008
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 High Cell Count (CL2) vs. Low Cell Count(CL1)
    Comparison groups
    Low Cell Count (CL1) v High cell count (CL2)
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9282
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Copy of High Cell Count (CL2) vs. Placebo (C1)
    Statistical analysis description
    The treatment groups were tested by using a two-sided t-test for the hypotheses and two-sided parametric confidence intervals. A sequentially rejective multiple test procedure on a family-wise error rate of α_global = 0.05 was used.
    Comparison groups
    High cell count (CL2) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0097
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Variability estimate
    Standard deviation

    Primary: Change of IEF of Visit 3 from baseline (Visit -5)

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    End point title
    		 Change of IEF of Visit 3 from baseline (Visit -5)
    End point description
    The frequency of incontinence episodes were documented by a bowel diary that was completed by the patient. In this study, the frequency of incontinence episodes was calculated as the number of incontinence episodes over 7 days.
    End point type
    Primary
    End point timeframe
    Changes in IEF at Visit 3 (84 days post implantation) compared to baseline Visit -5 (49 days prior implantation) in each treatment group.
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: IEF change
        arithmetic mean (standard deviation)
    -16.4 ( 13.3 )
    -18.4 ( 18.6 )
    -9 ( 13.1 )
    -13.8 ( 15.9 )
    Statistical analysis title
    		 High Cell Count (CL2) vs. Placebo (C1)
    Comparison groups
    High cell count (CL2) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Low Cell Count (CL1) vs. Placebo (C1)
    Comparison groups
    Low Cell Count (CL1) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0019
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 High Cell Count (CL2) vs. Low Cell Count(CL1)
    Comparison groups
    High cell count (CL2) v Low Cell Count (CL1)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5064
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Variability estimate
    Standard deviation

    Secondary: Change of visual analogue scale (VAS) of Visit 2 from baseline Visit -5

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    End point title
    		 Change of visual analogue scale (VAS) of Visit 2 from baseline Visit -5
    End point description
    The individual perception of UI complaints will be evaluated by each patient using a standardized VAS. The VAS is an instrument that measures a characteristic or attitude believed to range across a continuum of values and cannot easily be directly measured. It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient should mark the VAS with a vertical line representing his or her perception of the individual UI status. In the study, the two endpoints of the VAS are defined as "no complaints at all" (0 cm) and "worst complaints imaginable" (10 cm).
    End point type
    Secondary
    End point timeframe
    Changes of visual analogue scale (VAS) from Visit 2 (42 days post implantation) compared to baseline Visit -5 (49 day prior implantation) in each treatment group.
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: cm
        arithmetic mean (standard deviation)
    -2.0 ( 2 )
    -1.6 ( 2.2 )
    -1.0 ( 1.8 )
    -1.3 ( 1.6 )
    Statistical analysis title
    		 High Cell Count (CL2) vs. Placebo (C1)
    Comparison groups
    High cell count (CL2) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.1178
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - ITT/LOCF
    Statistical analysis title
    		 Low Cell Count (CL1) vs. Placebo (C1)
    Comparison groups
    Low Cell Count (CL1) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.0054
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - ITT/LOCF
    Statistical analysis title
    		 High Cell Count (CL2) vs. Low Cell Count(CL1)
    Comparison groups
    Low Cell Count (CL1) v High cell count (CL2)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.2788
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - ITT/LOCF
    Statistical analysis title
    		 High Cell Count (CL2) vs. Duloxetine (C2)
    Comparison groups
    High cell count (CL2) v Duloxetine (C2)
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.6519
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [4] - ITT/LOCF
    Statistical analysis title
    		 Low Cell Count (CL1) vs. Duloxetine
    Comparison groups
    Low Cell Count (CL1) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.1346
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [5] - ITT/LOCF
    Statistical analysis title
    		 Placebo (C1) vs. Duloxetine (C2)
    Comparison groups
    Duloxetine (C2) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.3872 [7]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [6] - ITT/LOCF
    [7] - ITT/LOCF

    Secondary: Change of visual analogue scale (VAS) of Visit 3 from baseline Visit -5

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    End point title
    		 Change of visual analogue scale (VAS) of Visit 3 from baseline Visit -5
    End point description
    The individual perception of UI complaints will be evaluated by each patient using a standardized VAS. The VAS is an instrument that measures a characteristic or attitude believed to range across a continuum of values and cannot easily be directly measured. It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient should mark the VAS with a vertical line representing his or her perception of the individual UI status. In the study, the two endpoints of the VAS are defined as "no complaints at all" (0 cm) and "worst complaints imaginable" (10 cm).
    End point type
    Secondary
    End point timeframe
    Changes of visual analogue scale (VAS) from Visit 3 (84 days post implantation) compared to baseline Visit -5 (49 day prior implantation) in each treatment group.
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: cm
        arithmetic mean (standard deviation)
    -2.0 ( 2.5 )
    -1.9 ( 2.4 )
    -1.4 ( 2.1 )
    -1.6 ( 1.9 )
    Statistical analysis title
    		 High Cell Count (CL2) vs. Placebo (C1)
    Comparison groups
    Duloxetine-placebo (C1) v High cell count (CL2)
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3961
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Low Cell Count (CL1) vs. Placebo (C1)
    Comparison groups
    Low Cell Count (CL1) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1388
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 High Cell Count (CL2) vs. Low Cell Count(CL1)
    Comparison groups
    Low Cell Count (CL1) v High cell count (CL2)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.476
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Placebo (C1) vs. Duloxetine (C2)
    Comparison groups
    Duloxetine-placebo (C1) v Duloxetine (C2)
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6736
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 High Cell Count (CL2) vs. Duloxetine (C2)
    Comparison groups
    High cell count (CL2) v Duloxetine (C2)
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.798
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Low Cell Count (CL1) vs. Duloxetine
    Comparison groups
    Low Cell Count (CL1) v Duloxetine (C2)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4884
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Incontinence Episode Frequency Reduction >=50% (V2 compared to V-5)

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    End point title
    		 Incontinence Episode Frequency Reduction >=50% (V2 compared to V-5)
    End point description
    The Incontinence Episodes Frequency (IEF) is calculated as number of incontinence episodes that occurred during 7 days preceding a visit.
    End point type
    Secondary
    End point timeframe
    Frequency of response measured as a reduction of the frequency of incontinence episodes by more than 50% under treatement from V2 compared to V-5 (baseline).
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: Number of Patients
    47
    42
    25
    18
    No statistical analyses for this end point

    Secondary: Incontinence Episode Frequency Reduction >=50% (V3 compared to V-5)

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    End point title
    		 Incontinence Episode Frequency Reduction >=50% (V3 compared to V-5)
    End point description
    The Incontinence Episodes Frequency (IEF) is calculated as number of incontinence episodes that occurred during 7 days preceding a visit.
    End point type
    Secondary
    End point timeframe
    Frequency of response measured as a reduction of the frequency of incontinence episodes by more than 50% under treatement from V3 compared to V-5 (baseline).
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: Number of Patients
    46
    45
    30
    17
    No statistical analyses for this end point

    Secondary: Incontinence Episode Frequency Reduction >=75% (V2 compared to V-5)

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    End point title
    		 Incontinence Episode Frequency Reduction >=75% (V2 compared to V-5)
    End point description
    The Incontinence Episodes Frequency (IEF) is calculated as number of incontinence episodes that occurred during 7 days preceding a visit.
    End point type
    Secondary
    End point timeframe
    Frequency of response measured as a reduction of the frequency of incontinence episodes by more than 75% under treatement from V2 compared to V-5 (baseline).
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: Number of Patients
    32
    22
    14
    9
    No statistical analyses for this end point

    Secondary: Incontinence Episode Frequency Reduction >=75% (V3 compared to V-5)

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    End point title
    		 Incontinence Episode Frequency Reduction >=75% (V3 compared to V-5)
    End point description
    The Incontinence Episodes Frequency (IEF) is calculated as number of incontinence episodes that occurred during 7 days preceding a visit.
    End point type
    Secondary
    End point timeframe
    Frequency of response measured as a reduction of the frequency of incontinence episodes by more than 75% under treatement from V3 compared to V-5 (baseline).
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: Number of Patients
    37
    28
    18
    9
    No statistical analyses for this end point

    Secondary: Short-Pad Test Results (V2 compared to Screening)

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    End point title
    		 Short-Pad Test Results (V2 compared to Screening)
    End point description
    The short-pas test is used to quantify urine leakage in patientes suffering from UI. The change in the pad weight of a patient was calculated by visit based on the weights prior and after the short-pad test.
    End point type
    Secondary
    End point timeframe
    Difference of pad weight (grams) of V2 compared to screening visit (56 day prior to treatment).
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    61
    56
    68
    32
    Units: gram(s)
        arithmetic mean (standard deviation)
    -9.9 ( 8.5 )
    -9.5 ( 9 )
    -5.3 ( 7.9 )
    -7.5 ( 10 )
    No statistical analyses for this end point

    Secondary: Short-Pad Test Results (V3 compared to Screening)

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    End point title
    		 Short-Pad Test Results (V3 compared to Screening)
    End point description
    The short-pas test is used to quantify urine leakage in patientes suffering from UI. The change in the pad weight of a patient was calculated by visit based on the weights prior and after the short-pad test.
    End point type
    Secondary
    End point timeframe
    Difference of pad weight (grams) of V3 compared to Screening (56 day prior to treatment).
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    61
    56
    68
    32
    Units: gram(s)
        arithmetic mean (standard deviation)
    -10.9 ( 9 )
    -11.3 ( 8.1 )
    -6.7 ( 9.4 )
    -6.8 ( 11.7 )
    No statistical analyses for this end point

    Secondary: Incontinence Quality of Life (I-QoL) (V2 compared to V-5)

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    End point title
    		 Incontinence Quality of Life (I-QoL) (V2 compared to V-5)
    End point description
    The patients' health-related QoL is assessed using the urinary I-QoL scale with 22-items specific to people with stress and mixed types of UI. It includes general questions on eliciting all areas of concern and specific probes into hypothesized areas of impact: social life, family life, job/work, intimate relationships, activities of daily life, household activities recreation and travel, mental health, physical health, and anxiety/depression.
    End point type
    Secondary
    End point timeframe
    Change of Patient's assessment based on the Quality of Life questionnaire (QoL) lifestyle score of V2 compared to baseline (V-5) in each treatment group
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: I-QoL total score
        arithmetic mean (standard deviation)
    26.5 ( 23.4 )
    28.5 ( 20.3 )
    12.1 ( 20.3 )
    14.2 ( 15.5 )
    Statistical analysis title
    		 High Cell Count (CL2) vs. Placebo (C1)
    Comparison groups
    High cell count (CL2) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Low Cell Count (CL1) vs. Placebo (C1)
    Comparison groups
    Low Cell Count (CL1) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0007
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 High Cell Count (CL2) vs. Low Cell Count(CL1)
    Comparison groups
    High cell count (CL2) v Low Cell Count (CL1)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5667
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Low Cell Count (CL1) vs. Duloxetine
    Comparison groups
    Low Cell Count (CL1) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0134
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Placebo (C1) vs. Duloxetine (C2)
    Comparison groups
    Duloxetine-placebo (C1) v Duloxetine (C2)
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4836
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 High Cell Count (CL2) vs. Duloxetine (C2)
    Comparison groups
    High cell count (CL2) v Duloxetine (C2)
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Incontinence Quality of Life (I-QoL) (V3 compared to V-5)

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    End point title
    		 Incontinence Quality of Life (I-QoL) (V3 compared to V-5)
    End point description
    The patients' health-related QoL is assessed using the urinary I-QoL scale with 22-items specific to people with stress and mixed types of UI. It includes general questions on eliciting all areas of concern and specific probes into hypothesized areas of impact: social life, family life, job/work, intimate relationships, activities of daily life, household activities recreation and travel, mental health, physical health, and anxiety/depression.
    End point type
    Secondary
    End point timeframe
    Change of Patient's assessment based on the Quality of Life questionnaire (QoL) lifestyle score of V3 compared to baseline (V-5) in each treatment group.
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: I-QoL total score
        arithmetic mean (standard deviation)
    31.3 ( 25.3 )
    32.3 ( 21.3 )
    13.8 ( 22.1 )
    20.2 ( 17.8 )
    Statistical analysis title
    		 High Cell Count (CL2) vs. Placebo (C1)
    Comparison groups
    High cell count (CL2) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Low Cell Count (CL1) vs. Placebo (C1)
    Comparison groups
    Low Cell Count (CL1) v Duloxetine-placebo (C1)
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0002
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 High Cell Count (CL2) vs. Low Cell Count(CL1)
    Comparison groups
    Low Cell Count (CL1) v High cell count (CL2)
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6985
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Placebo (C1) vs. Duloxetine (C2)
    Comparison groups
    Duloxetine-placebo (C1) v Duloxetine (C2)
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1284
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 High Cell Count (CL2) vs. Duloxetine (C2)
    Comparison groups
    High cell count (CL2) v Duloxetine (C2)
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0094
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Low Cell Count (CL1) vs. Duloxetine
    Comparison groups
    Low Cell Count (CL1) v Duloxetine (C2)
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0438
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Clinical Global Impression (CGI) improvement: very much improved

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    End point title
    		 Clinical Global Impression (CGI) improvement: very much improved
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V3.
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    61
    56
    68
    32
    Units: Number of Patients
    29
    21
    8
    5
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: much improved

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    End point title
    		 Clinical Global Impression (CGI) improvement: much improved
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V3.
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: Number of Patients
    14
    22
    12
    7
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: minimally improved

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    End point title
    		 Clinical Global Impression (CGI) improvement: minimally improved
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V3.
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: Number of Patients
    8
    8
    13
    7
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: no change

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    End point title
    		 Clinical Global Impression (CGI) improvement: no change
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: Number of Patients
    8
    2
    19
    5
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: minimally worse

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    End point title
    		 Clinical Global Impression (CGI) improvement: minimally worse
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V3.
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: Number of Patients
    1
    1
    3
    1
    No statistical analyses for this end point

    Secondary: Clinical Global Impression (CGI) improvement: much worse

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    End point title
    		 Clinical Global Impression (CGI) improvement: much worse
    End point description
    Improvement of urinary incontinence was assessed using the Clinical Global Impression Scale, which is a standardized assessment tool that allows the physician to rate the severity of illness, change over time, and efficiency of treatment, taking into account the patient's clinical condition and the severity of side effects. The CGI scale is widely used in clinical studies as an outcome measure.
    End point type
    Secondary
    End point timeframe
    Investigator's assessment by the Clinical Global Impression (CGI-I) score at V3.
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    60
    56
    68
    32
    Units: Number of Patients
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Urinary volume lost during incontinence episodes (V3 compared to V-5)

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    End point title
    		 Urinary volume lost during incontinence episodes (V3 compared to V-5)
    End point description
    The volume of micturition episodes of a patient was determined using diary entriesfor the last three days prior to a visit.
    End point type
    Secondary
    End point timeframe
    Difference of voiding volume during incontinence episodes of V3 compared to baseline (V-5).
    End point values
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Number of subjects analysed
    61
    56
    68
    32
    Units: mL
        arithmetic mean (standard deviation)
    -13.1 ( 75.08 )
    -5.9 ( 55.66 )
    1 ( 51.22 )
    4.5 ( 59.26 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    June 2010 - June 2011
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Low Cell Count (CL1)
    Reporting group description
    		 227 patients compsoe the safety set. 133 patients of the safety set underwent biopsy and cell implatation. 72 patients received no treatment.

    Reporting group title
    High cell count (CL2)
    Reporting group description
    		 227 patients compsoe the safety set. 133 patients of the safety set underwent biopsy and cell implatation. 72 patients received no treatment.

    Reporting group title
    Duloxetine-placebo (C1)
    Reporting group description
    		 227 patients compsoe the safety set. 133 patients of the safety set underwent biopsy and cell implatation. 72 patients received no treatment.

    Reporting group title
    Duloxetine (C2)
    Reporting group description
    		 227 patients compsoe the safety set. 133 patients of the safety set underwent biopsy and cell implatation. 72 patients received no treatment.

    Serious adverse events
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 64 (7.81%)
    3 / 56 (5.36%)
    4 / 72 (5.56%)
    1 / 35 (2.86%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Tachyarrhythmia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial insufficiency
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Post-traumatic headache
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Hepatitis B
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 56 (1.79%)
    0 / 72 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Low Cell Count (CL1) High cell count (CL2) Duloxetine-placebo (C1) Duloxetine (C2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 64 (26.56%)
    20 / 56 (35.71%)
    33 / 72 (45.83%)
    15 / 35 (42.86%)
    Vascular disorders
    All PT's in this SOC
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 56 (1.79%)
    10 / 72 (13.89%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    11
    2
    Surgical and medical procedures
    All PT's in this SOC
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 56 (0.00%)
    0 / 72 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    All PT's in this SOC
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 56 (0.00%)
    3 / 72 (4.17%)
    1 / 35 (2.86%)
         occurrences all number
    4
    0
    4
    1
    Reproductive system and breast disorders
    All PT's in this SOC
         subjects affected / exposed
    1 / 64 (1.56%)
    3 / 56 (5.36%)
    1 / 72 (1.39%)
    0 / 35 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Respiratory, thoracic and mediastinal disorders
    All PT's in this SOC
         subjects affected / exposed
    0 / 64 (0.00%)
    3 / 56 (5.36%)
    3 / 72 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    0
    3
    4
    0
    Psychiatric disorders
    All PT's in this SOC
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    3 / 72 (4.17%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    3
    2
    Investigations
    All PT's in this SOC
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 56 (1.79%)
    5 / 72 (6.94%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    5
    1
    Injury, poisoning and procedural complications
    All PT's in this SOC
         subjects affected / exposed
    3 / 64 (4.69%)
    1 / 56 (1.79%)
    2 / 72 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    3
    1
    3
    0
    Cardiac disorders
    All PT's in this SOC
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 56 (1.79%)
    4 / 72 (5.56%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    5
    0
    Nervous system disorders
    All PT's in this SOC
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 56 (1.79%)
    9 / 72 (12.50%)
    6 / 35 (17.14%)
         occurrences all number
    2
    2
    13
    6
    Eye disorders
    All PT's in this SOC
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    All PT's in this SOC
         subjects affected / exposed
    3 / 64 (4.69%)
    2 / 56 (3.57%)
    14 / 72 (19.44%)
    11 / 35 (31.43%)
         occurrences all number
    4
    2
    21
    16
    Hepatobiliary disorders
    All PT's in this SOC
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    2 / 72 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Skin and subcutaneous tissue disorders
    All PT's in this SOC
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    2 / 72 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    2
    2
    Renal and urinary disorders
    All PT's in this SOC
         subjects affected / exposed
    7 / 64 (10.94%)
    5 / 56 (8.93%)
    0 / 72 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    8
    6
    0
    1
    Musculoskeletal and connective tissue disorders
    All PT's in this SOC
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 56 (1.79%)
    2 / 72 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Infections and infestations
    All PT's in this SOC
         subjects affected / exposed
    4 / 64 (6.25%)
    7 / 56 (12.50%)
    5 / 72 (6.94%)
    2 / 35 (5.71%)
         occurrences all number
    6
    7
    8
    2
    Metabolism and nutrition disorders
    All PT's in this SOC
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 56 (0.00%)
    1 / 72 (1.39%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    2
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jan 2010
    - Change of Study duration in total and per patient, prolongation of screening period and cell preparation - Change of patients planned for a 9 month follow up study (only patients with a decrease of at least 25% in the IEF score) - Addition of age limits for Germany and CZ - Addition of Inclusion Criterion (female patients willing to use acceptable methods of contraception) - Addition of Interim Inclusion Criterion (patients with an IEF of at least 12 within the last 7 days prior baseline) - Addition of Exclusion Criterion 23, 24, 25 (patients with malignagnt disease, with chronical bacterial infections, or with hypersensitivitiy to any component of the product) - Introduction of a randomization list and addition of detailed description of the randomization process and unblinding
    27 Jan 2010
    Addition of Exlusion Cirterion No. 24
    10 Jun 2010
    Changes based on a new IMPD
    08 Jul 2010
    Follow up will be extended to all patients
    13 Aug 2010
    Interim Analysis is introduced.
    27 Sep 2010
    Overall study duration is introduced due to prolonged patient recruitment.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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