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    Clinical Trial Results:
    Evaluation of the Safety of Cell Bandage in the Treatment of Meniscal Tears

    Summary
    EudraCT number
    		 2010-024162-22
    Trial protocol
    		 GB  
    Global end of trial date
    26 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2022
    First version publication date
    04 Aug 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACTL-P001-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Azellon Ltd (a subsidiary of NTL Biologica)
    Sponsor organisation address
    Boston House, 2a Boston Road , Henley on Thames, Oxon, United Kingdom, RG9 1DY
    Public contact
    Executive Chairman, Azellon Ltd (a subsidiary of NTL Biologica), +44 7484631765, igraney@ntlbiologica.com
    Scientific contact
    Executive Chairman, Azellon Ltd (a subsidiary of NTL Biologica), +44 7484631765, igraney@ntlbiologica.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
    01 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was: - To evaluate the safety of the Cell Bandage. The secondary objective of the trial was: - To evaluate the clinical outcome of the use of Cell Bandage.
    Protection of trial subjects
    The study was conducted in accordance with the principles set forth in the Declaration of Helsinki as amended in 2013 (Brazil), the Guidelines of the International Conference on Harmonisation (ICH) on Good Clinical Practice (GCP) (CPMP/ICH/135/95), as well as the requirements of the European Union Data Protection Directive 95/46/EC, and other applicable regulatory requirements.
    Background therapy
    		 The menisci are fibrocartilaginous structures in the knee. There is one on each side of the joint, the medial and lateral menisci. The medial meniscus is approximately “C” shaped and the lateral meniscus is almost circular, they are both triangular in cross section. The menisci have a role in the load distribution, stability, lubrication and nutrition in the knee. Loss of meniscal tissue predisposes to osteoarthritis. Injury to the meniscal cartilage is one of the most common knee injuries and the most common indication for knee surgery. There are two broad groups of meniscal tears, those in the younger adult, which tend to be traumatic in nature and those in the older adult that occur partly due to the increased stiffness of the meniscus that occurs with ageing and degeneration. Traumatic lesions are more commonly associated with longitudinal tears and vertical, transverse or radial tears. Degenerative tears are more commonly horizontal tears or complex tears. Other patterns of tears that occur, such as flap and horn are variations of the above patterns. The standard treatment of meniscal tears in the adult is to remove the damaged portion of the cartilage when there is pain, locking or giving way of the knee. When the tear is located purely in the outer third of the cartilage where the blood supply is retained (red-red zone), a relatively rare injury, there is the option to repair the cartilage with sutures. The red-red zone is fully vascular and therefore has an excellent healing prognosis. The red white zone is at the border of vascular supply and has a generally good healing prognosis. The white white zone is relatively avascular and has a poor prognosis for healing.
    Evidence for comparator
    		 Not applicable - no comparator used.
    Actual start date of recruitment
    10 Sep 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 7 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study recruitment was undertaken in the United Kingdom. The recruitment process began in September 2012 and concluded in November 2012. 13 patients were deemed eligible, of which 5 patients were treated. Of the 5 patients who were treated, only 1 patient completed all 7 year follow up assessments.

    Pre-assignment
    Screening details
    		 Patients were screened to the inclusion/exclusion criteria of the protocol. The following assessments were performed: Informed consent, Medical History, Physical Exam including knee exam, Demographics, ECG, Vital Signs and Safety Laboratory Testing/Urinalysis, MRI & specific markers of pain/inflammation measured through questionnaires and testing.

    Pre-assignment period milestones
    Number of subjects started
    		 15 [1]
    Number of subjects completed
    		 5

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No Cell Bandage available: 2
    Reason: Number of subjects
    		 Meniscal Tear not suitable: 2
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 No Cell Bandage released: 1
    Reason: Number of subjects
    		 Clotting Issues with Samples: 3
    Reason: Number of subjects
    		 Screen Fail at Pre-Operative Assessment: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects assigned to the pre-assignment period is indicative of the number of subjects initially screened for participation in the study. The subsequent number of enrolled subjects reflects those who were screened and enrolled into the study. Of the 15 subjects who initially screened, only 5 were subsequently enrolled onto the study and received treatment.
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A - this study was open label.

    Arms
    Arm title
    		 Overall Treated Patient Population
    Arm description
    		 This subject analysis set corresponds to the 5 enrolled patients who were treated with implantation of the cell bandage. This analysis set will be utilised to report data in relation to all endpoints within the study. Patients enrolled were followed up for a period of up to 7-years post-operative implantation of cell bandage. Of the 5 patients who were treated, only 1 patient completed all 7 year follow up assessments.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cell Bandage
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intracartilaginous use
    Dosage and administration details
    Single dose (single implantation) of Cell Bandage: product contains 1 million cells/sq cm of autologous mesenchymal stem cells. Implantation occurred on the baseline visit with follow up assessments carried out at the following milestones: 1 week post-op, 1 month post-op, 3 months post-op, 6 months post-op, 1 year post-op, 2 years post-op, 3 years post-op, 4 years post-op, 5 years post-op, 6 years post-op & 7 years post-op.

    Number of subjects in period 1
    		Overall Treated Patient Population
    Started
    5
    Completed
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 5 5
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.0 ( 3.74 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 4 4
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 177.3 ( 8.34 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 81.48 ( 8.90 ) -

    End points

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    End points reporting groups
    Reporting group title
    Overall Treated Patient Population
    Reporting group description
    		 This subject analysis set corresponds to the 5 enrolled patients who were treated with implantation of the cell bandage. This analysis set will be utilised to report data in relation to all endpoints within the study. Patients enrolled were followed up for a period of up to 7-years post-operative implantation of cell bandage. Of the 5 patients who were treated, only 1 patient completed all 7 year follow up assessments.

    Primary: Treatment Emergent Adverse Events

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    End point title
    		 Treatment Emergent Adverse Events [1]
    End point description
    This primary endpoint relates to the number of subjects who reported a treatment emergent adverse event (TEAEs) during the study. Forty (40) TEAEs were reported in the 7 year post operative period by 5 patients who received the Cell Bandage. Three (3) patients reported SAEs during the study. At 2 years post operative, 2 patients had undergone partial or full meniscectomy in the affected knee (after implantation of the Cell Bandage) for SAEs of severe, definitely related meniscus injury and severe definitely related joint swelling, arthralgia and joint lock. A third patient reported an SAE of moderate, possibly related post operative wound complication. Another patient also underwent partial meniscectomy (SAE) in the contralateral knee (no implantation with Cell Bandage) for severe not related arthralgia and meniscal injury. With exception of joint lock (catching), breast mass and meniscal injury, arthralgia and joint swelling, all TEAEs resolved.
    End point type
    Primary
    End point timeframe
    Collection of treatment emergent adverse events occurred from the point of implantation of the cell bandage until completion of the 7-year post-operative assessment.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Treatment Emergent Adverse Events were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 Overall Treated Patient Population
    Number of subjects analysed
    5
    Units: Number of Patients
    5
    No statistical analyses for this end point

    Primary: Efficacy - Percentage of patients that have partial or full meniscectomy during or after the initial procedure.

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    End point title
    		 Efficacy - Percentage of patients that have partial or full meniscectomy during or after the initial procedure. [2]
    End point description
    This primary endpoint will report the number of subjects who underwent a partial or full meniscectomy during or after the initial procedure within the study follow-up period. At 2 year post operative, 2 patients had undergone partial or full meniscectomy in the affected knee (after implantation of the Cell Bandage) as a result of SAEs and 1 patient had undergone partial meniscectomy in the contralateral knee as a result of severe meniscal injury. All fully recovered after surgery.
    End point type
    Primary
    End point timeframe
    Implantation to end of 2 year initial study.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Efficacy endpoints were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 Overall Treated Patient Population
    Number of subjects analysed
    5
    Units: Number of post-treatment meniscectomies
    2
    No statistical analyses for this end point

    Primary: Laboratory Parameters

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    End point title
    		 Laboratory Parameters [3]
    End point description
    This primary endpoint will report the number of subjects who had out of range results for any of the Laboratory Parameters (biochemistry, haematology & urinalysis). This endpoint will only report number of subjects who had out of range results from Day 1 onwards following implantation of the cell bandage until the completion of the 2 year post-operative study assessment visit. There were no clinically significant biochemistry, haematology or urinalysis results during the study.
    End point type
    Primary
    End point timeframe
    Laboratory Parameters (biochemistry, haematology and urinalysis) were measured at set time points from the baseline visit until the 2 year post-operative study assessment visit.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Laboratory Parameters were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 Overall Treated Patient Population
    Number of subjects analysed
    5
    Units: Number of Patients
    4
    No statistical analyses for this end point

    Primary: Post-Surgical Complications

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    End point title
    		 Post-Surgical Complications [4]
    End point description
    This primary endpoint will report the number of subjects who reported a post-operative surgical complication following implantation of the cell bandage. There were no post surgical complications following implantation of the Cell Bandage (chronic pain, arthrofibrosis, damage to the neurovasculature, osteonecrosis, post surgical inflammation, infection, bleeding and deep vein thrombosis), although 1 patient did require prolonged hospitalisation (> 72 h) following implantation for pain.
    End point type
    Primary
    End point timeframe
    Post-Surgical Complications were evaluated at set time points from the baseline visit until the 7 year post-operative study assessment visit.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Post-Surgical Complications were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 Overall Treated Patient Population
    Number of subjects analysed
    5
    Units: Number of Patients
    0
    No statistical analyses for this end point

    Secondary: Summary of Current Knee Function - Daily Living Scores

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    End point title
    		 Summary of Current Knee Function - Daily Living Scores
    End point description
    The IKDC scores were measured on a scale of 0-10 with measures scored as follows: Pain Frequency: 0 = constant pain, 10 = never Pain Severity: 0 = worst pain, 10 = no pain Overall, current function of the knee (daily living activities) improved in patients who received the Cell Bandage. In the majority of patients, activity levels and current function of the knee had improved at 3 and 6 months post operative when compared to pre operative (mean scores 6 and 8 vs 4, respectively. One patient saw a slight reduction in current function of the knee at 3 months post operative, although function had improved by 6 months post operative. One patient saw no change in current function of the knee at 3 months post operative, although function had improved by 6 months post operative. In all patients, activity levels and current function of the knee at their final visit remained higher than that observed pre operative.
    End point type
    Secondary
    End point timeframe
    Time points for evaluation of Daily Living Scores (IKDC) were as follows: Baseline, 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years and 7 years post-operative from implantation of the cell bandage.
    End point values
    		 Overall Treated Patient Population
    Number of subjects analysed
    5
    Units: Number of Patients
    5
    Attachments
    		 Summary of Daily Living Scores Data
    No statistical analyses for this end point

    Secondary: Post-Operative Medication Use

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    End point title
    		 Post-Operative Medication Use
    End point description
    Following cell bandage implantation, post operative pain medication included paracetamol (taken by 4 patients), ibuprofen (taken by 3 patients), codeine phosphate (taken by 4 patients), tramadol (taken by 3 patients) and diclofenac (taken by 5 patients) each taken for between 1 day and 2 months. Two (2) patients also required short term morphine taken for between 2-4 days. One patient also received paracetamol for post operative pain and pain that started prior to the operation (January 2013) and continued post-operatively (June 2013).
    End point type
    Secondary
    End point timeframe
    Time points for evaluation of Post-Operative Medication Use were as follows: Baseline, 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years and 7 years post-operative from implantation of the cell bandage.
    End point values
    		 Overall Treated Patient Population
    Number of subjects analysed
    5
    Units: Number of Patients
    5
    No statistical analyses for this end point

    Secondary: Summary of VAS Pain Scores

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    End point title
    		 Summary of VAS Pain Scores
    End point description
    The VAS pain scale was measured on a scale of 0-10 with measured scored as follows: Pain Frequency: 0 = constant pain, 10 = never Pain Severity: 0 = worst pain, 10 = no pain Overall, the frequency and intensity of knee pain reduced in patients who received the Cell Bandage with reduction in pain observed from the 1 week post-operative assessment. in all patients, the frequency of pain was greatly reduced at 3 and 6 months post operative when compared to pre operative (mean scores of 8 and 9 vs 4, respectively) and with the exception of one patient (who experienced a slight worsening of pain severity at 3 months post operative), all patients were also in less severe pain at these time points (mean scores of 7 and 8 vs 5, respectively). All patients remained in less frequent and less intense pain at their final visit, with 2 patients reporting no pain at the final visit.
    End point type
    Secondary
    End point timeframe
    Time points for evaluation of VAS Pain Scores were as follows: Baseline, 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years and 7 years post-operative from implantation of the cell bandage.
    End point values
    		 Overall Treated Patient Population
    Number of subjects analysed
    5
    Units: Number of Patients
    5
    Attachments
    		 Summary of VAS Pain Scores Data
    No statistical analyses for this end point

    Secondary: Summary of Range of Motion

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    End point title
    		 Summary of Range of Motion
    End point description
    Overall, the range of motion of the affected knee improved in all patients who received the Cell Bandage. In the majority of patients, the range of motion of the affected knee (active and passive) had improved at 3 and 6 months post operative when compared to pre operative (mean change from baseline; active 4.4 and 6.4 degrees, respectively; passive 5.2 and 4.4 degrees, respectively. One patient saw no change in passive range of motion of the affected knee at 3 and 6 months post operative, although active range of motion had improved by 6 months post operative. One patient saw a reduction in range of motion (active and passive) at these time points, although range of motion had improved by 1 year post operative. In all patients, the range of motion in affected knee (active and passive) at their final visit remained higher than that observed pre operative.
    End point type
    Secondary
    End point timeframe
    Time points for evaluation of Range of Motion were as follows: Baseline, 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years and 7 years post-operative from implantation of the cell bandage.
    End point values
    		 Overall Treated Patient Population
    Number of subjects analysed
    5
    Units: Number of Subjects
    5
    Attachments
    		 Summary of Range of Motion Data
    No statistical analyses for this end point

    Secondary: Summary of Tegener Questionnaire Results

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    End point title
    		 Summary of Tegener Questionnaire Results
    End point description
    For the majority of patients, there was little difference in the work and sporting activities that they were able to participate in following implantation of the Cell Bandage. Review of individual patient data did, however, demonstrate that for 1 patient, the ability to participate in work and sporting activities improved from being “on sick leave or disability because of knees” to being able to participate in competitive sports: Soccer lower divisions, ice hockey, wrestling and/or gymnastics" within a 1 year period, an activity level that was sustained when assessed at the 2 and 4 (final) year visit. It should also be noted that all patients indicated difficulty with work and sporting activities 1 month post operative, with 4 being “on sick leave or disability because of knees” and 1 only able to participate in “sedentary work or walking on even ground”. This probably reflects the fact that the knee was swollen and recovering from surgery during this period.
    End point type
    Secondary
    End point timeframe
    Time points for evaluation of Tegner Questionnaire Results were as follows: Baseline, 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years and 7 years post-operative from implantation of the cell bandage.
    End point values
    		 Overall Treated Patient Population
    Number of subjects analysed
    5
    Units: Number of Patients
    5
    Attachments
    		 Summary of Tegner Questionnaire Data
    No statistical analyses for this end point

    Secondary: Summary of Lysholm Questionnaire Results

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    End point title
    		 Summary of Lysholm Questionnaire Results
    End point description
    Overall, the frequency of common complaints associated with knee problems was reduced in patients who received the Cell Bandage. In all patients, the frequency of 1 or more common complaints (“limp”, knee "locking" and "catching", "instability", "pain", “swelling”, "climbing stairs" and "squatting") was reduced at 3 and 6 months post operative when compared to pre operative. In all patients, the frequency of knee complaints at their final visit remained lower than that observed pre operative. A worsening of knee complaints was observed in two patients at 1 year post operative and one patient at 2 years and 6 years post operative when compared to the previous visit and is likely a reflection of deterioration in knee function during this these periods that resulted in surgical and medical action.
    End point type
    Secondary
    End point timeframe
    Time points for evaluation of Lysholm Questionnaire Results were as follows: Baseline, 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years and 7 years post-operative from implantation of the cell bandage.
    End point values
    		 Overall Treated Patient Population
    Number of subjects analysed
    5
    Units: Number of Patients
    5
    Attachments
    		 Summary of Lysholm Questionnaire Data
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the time of signing informed consent until completion of the 7-year post-operative study visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Adverse Event Safety Population
    Reporting group description
    		 This reporting groups corresponds to the 5 enrolled patients in the study for whom adverse events were reported throughout the study.

    Serious adverse events
    		 Adverse Event Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Meniscus injury
    Additional description: Of the 3 reported SAEs, 2 of the patients re-tore the meniscus in the treated knee. The third patient tore the meniscus in the untreated knee i.e., this SAE was unrelated to treatment.
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Meniscus removal
    Additional description: Of the 3 reported SAEs, 2 of the patients underwent meniscectomy related to the treated knee. A third patient underwent meniscectomy of the untreated knee i.e., this SAE was unrelated to treatment.
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Arthroscopy
    Additional description: Of the 3 reported SAEs, 2 of the patients underwent meniscectomy related to the treated knee. A third patient underwent meniscectomy of the untreated knee i.e., this SAE was unrelated to treatment.
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse Event Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Joint injury
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    2
    Fall
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    3
    Postoperative wound complication
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Breast mass
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Joint lock
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2
    Arthralgia
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    6
    Joint swelling
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    4
    Back pain
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 5 (60.00%)
         occurrences all number
    4
    Gastroenteritis
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 May 2012
    Substantial Amendment 01 - The amendment was issued to change the CRO details from Factory CRO to Simbec. The amended protocol (version 2.5, 10 May 2012) (Appendix 16.1.1.3), and associated documents were approved by the REC on 24 May 2012. The protocol was updated to version 2.5, 10 May 2012 and submitted for REC approval, but the protocol footers were not updated in error. As a result, the REC approval document states approval for version 2.4, 21 April 2012. When the error was noted a non substantial amendment was issued to confirm the correct version of the amended protocol approved on 24 May 2012, was version 2.5, 10 May 2012.
    03 Aug 2012
    Substantial Amendment 02 - The amendment was issued to include additional urine pregnancy tests (on day of stem cell harvest and at the 3 month and 1 year post operative visits), correction of typographical errors in synopsis, update contact telephone numbers and modify the age range for inclusion in the study from 18 35 to 18 55 years old. The protocol was initially updated to version 2.6, 13 July 2012 (to include additional urine pregnancy tests (on day of stem cell harvest and at the 3 month and 1 year post operative visits), correction of typographical errors in synopsis and update contact telephone numbers), and together with associated documents submitted for REC approval, but before REC review, the protocol was updated again to version 2.7, 3 August 2012) (Appendix 16.1.1.4) and re submitted together with associated documents, in order to modify the age range for inclusion in the study from 18 35 to 18 55 years old. The amended protocol (version 2.7, 3 August 2012) and associated documents were approved by the REC on 15 August 2012.
    10 Feb 2014
    AZ/CTA/01-004 - The amendment was issued to add an additional MRI scan at the 1 year post operative visit. The protocol was updated to version 2.9, 10 February 2014 (Appendix 16.1.1.6), and together with associated documents submitted for REC approval. The amended protocol (version 2.9, 10 February 2014) and associated documents were approved by the REC on 23 April 2014.
    15 Aug 2017
    AZ/CTA/01 005 - The amendment was issued to add an additional MRI scan at the 5 year post operative visit. The protocol was updated to version 3.0, 15 August 2017 (Appendix 16.1.1.7), and together with associated documents submitted for REC approval. The amended protocol (version 3.0, 15 August 2017) and associated documents were approved by the REC on 03 October 2017.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    08 Oct 2012
    During the cell culture of bone marrow aspirates from the first three patients, a membrane appeared on the surface of the cultures which had not been observed during process validation. The decision was made to temporarily halt the trial so that this could be thoroughly investigated.
    23 Nov 2012

    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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