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Clinical Trial Results:
Phase I / II, multicenter, double blind, randomized, comparison of two groups and two doses, to evaluate the safety and efficacy of autologous ASCs in the treatment of fecal incontinence.

Summary
EudraCT number	2010-021659-17
Trial protocol	ES
Global end of trial date	29 Sep 2017

Results information
Results version number	v1(current)
This version publication date	29 Nov 2023
First version publication date	29 Nov 2023
Other versions
Summary report(s)	Final Report_Summary

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CMMAd/InFe/2011

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Fundación Pública Andaluza Progreso y Salud M.P.

Sponsor organisation address

Avda. Américo Vespucio 15 · Edificio S-2 ·2ª Pta., Sevilla, Spain, 41092

Public contact

ROSARIO CARMEN MATA ALCAZAR-CABALLERO, Fundación Pública Andaluza Progreso y Salud M.P., rosario.mata@juntadeandalucia.es

Scientific contact

ROSARIO CARMEN MATA ALCAZAR-CABALLERO, Fundación Pública Andaluza Progreso y Salud M.P., rosario.mata@juntadeandalucia.es

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

13 Aug 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

29 Sep 2017

Global end of trial reached?

Yes

Global end of trial date

29 Sep 2017

Was the trial ended prematurely?

Main objective of the trial

To evaluate the safety and feasibility of therapy with autologous mesenchymal stem cells from adipose tissue in the treatment of fecal incontinence.

Protection of trial subjects

All patients have the right to discontinue the study at any time and may be withdrawn from the study for any reason of benefit to their well-being. On the other hand, in accordance with good clinical practice, those patients who have abandoned the study prematurely will have been recommended another alternative and, in the event that the cause has been a significant Adverse Event, the patients have been controlled by the investigator until appropriate termination, that is, until the adverse event has disappeared or until it has been determined to be permanent.

Background therapy

Evidence for comparator

Actual start date of recruitment

03 Sep 2013

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

24 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Spain: 16

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

During the recruitment phase, which lasted 12 months, a total of 18 participating subjects were included. These patients were randomly assigned to one of the intervention groups (8 patients in the CMMAd group / 10 patients in the placebo group).

Screening details

A unique internal sphincter defect and/or external, at any level of the anal canal, of any cause. Severity of faecal incontinence of 12 or more in the Wexner Score and/or at least six episodes of faecal incontinence for a period of 28 days. Duration of faecal incontinence of at least two years prior to inclusion.

Period 1 title

Recruitment and follow-up (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Group A

Arm description

Autologous mesenchymal stem cell suspension from adipose tissue (CMMAd) in a dose of 40 million, administered by intralesional injection.

Arm type

Experimental

Investigational medicinal product name

Autologous mesenchymal stem cells from adipose tissue (CMMAd)

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Injection , Intralesional use

Dosage and administration details

40x10E6 CMMAd

Group B (control)

Arm description

Placebo (Lactated Ringer's solution)

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Intralesional use

Dosage and administration details

Placebo

Number of subjects in period 1	Group A	Group B (control)
Started	8	8
Completed	8	8

Baseline characteristics

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Reporting group title

Group A

Reporting group description

Autologous mesenchymal stem cell suspension from adipose tissue (CMMAd) in a dose of 40 million, administered by intralesional injection.

Reporting group title

Group B (control)

Reporting group description

Placebo (Lactated Ringer's solution)

Reporting group values	Group A	Group B (control)	Total
Number of subjects	8	8	16
Age categorical
Units: Subjects
Adults (18-64 years)	8	8	16
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
From 65-84 years	0	0	0
85 years and over	0	0	0
Not recorded	0	0	0
Age continuous
Units: years
median (full range (min-max))	63.38 (44 to 75)	48.90 (33 to 78)	-
Gender categorical
Units: Subjects
Female	6	5	11
Male	2	3	5
Female and male
Units: Subjects
In utero	0	0	0
Preterm newborn infants	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	8	8	16
From 65-84 years	0	0	0
85 years and over	0	0	0
Not recorded	0	0	0
Faecal Incontinence
Units: subjects
median (full range (min-max))	63.38 (44 to 75)	48.90 (33 to 78)	-

Subject analysis set title

Feasibility and safety

Subject analysis set type

Full analysis

Subject analysis set description

Feasibility and safety

Subject analysis sets values	Feasibility and safety
Number of subjects	16
Age categorical
Units: Subjects
Adults (18-64 years)	16
In utero	0
Preterm newborn infants (gestational age < 37 wks)	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
From 65-84 years	0
85 years and over	0
Not recorded	0
Age continuous
Units: years
median (full range (min-max))
Gender categorical
Units: Subjects
Female	12
Male	4
Female and male
Units: Subjects
In utero	0
Preterm newborn infants	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)	16
From 65-84 years	0
85 years and over	0
Not recorded	0
Faecal Incontinence
Units: subjects
median (full range (min-max))

End points

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Reporting group title

Group A

Reporting group description

Autologous mesenchymal stem cell suspension from adipose tissue (CMMAd) in a dose of 40 million, administered by intralesional injection.

Reporting group title

Group B (control)

Reporting group description

Placebo (Lactated Ringer's solution)

Subject analysis set title

Feasibility and safety

Subject analysis set type

Full analysis

Subject analysis set description

Feasibility and safety

Primary: Safety

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End point title

Safety ^[1]

End point description

End point type

Primary

End point timeframe

During the study

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: No statistical analyses for this end point

End point values	Group A	Group B (control)
Number of subjects analysed	8	8
Units: units	8	8

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From the inclusion of the first patient to the last visit of the last patient

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Hip fracture

Reporting group description

Reporting group title

Gastrointestinal disorders

Reporting group description

Reporting group title

Post-procedure hematoma

Reporting group description

Serious adverse events	Hip fracture	Gastrointestinal disorders	Post-procedure hematoma
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Hip fracture
subjects affected / exposed	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Post-procedure hematoma
subjects affected / exposed	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Gastrointestinal disorders
subjects affected / exposed	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Hip fracture	Gastrointestinal disorders	Post-procedure hematoma
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)
Injury, poisoning and procedural complications
Hip fracture
subjects affected / exposed	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)
occurrences all number	0	0	0
Blood and lymphatic system disorders
Post-procedure hematoma
subjects affected / exposed	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)
occurrences all number	0	0	0
Gastrointestinal disorders
Gastrointestinal disorders
subjects affected / exposed	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)
occurrences all number	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

11 Sep 2013

This amendment comes from mainly brought about by the modification and/or clarification of certain inclusion criteria, and exclusion criteria, given that by experience cumulative of the research team since the final version was produced of the protocol is considered appropriate Update these criteria

24 Mar 2014

New centers are added

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
Phase I / II, multicenter, double blind, randomized, comparison of two groups and two doses, to evaluate the safety and efficacy of autologous ASCs in the treatment of fecal incontinence.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Safety

Primary: Safety

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: Phase I / II, multicenter, double blind, randomized, comparison of two groups and two doses, to evaluate the safety and efficacy of autologous ASCs in the treatment of fecal incontinence.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Safety

Primary: Safety

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Phase I / II, multicenter, double blind, randomized, comparison of two groups and two doses, to evaluate the safety and efficacy of autologous ASCs in the treatment of fecal incontinence.