Faecal IncontinencePhase 1/2NCT02292628

Study, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence

A Phase 1/2 study testing Infusion of mesenchymal stem cells from adipose tissue in people with Faecal Incontinence, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a clinical trial phase I/II, double blind, randomized to compare in two groups of patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from the adipose tissue (CMMAd) in the treatment of the faecal incontinence. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Faecal Incontinence
What is being tested?: Infusion of mesenchymal stem cells from adipose tissue
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 4 sitesSpain
Study dates: Oct 2013to Sep 2017
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females in the age group of 18-80 yrs.
A unique internal sphincter defect and / or external (no more than 100 º), at any level of the anal canal, of any cause (except those described in the exclusion criteria).
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.
Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent.

Who cannot join

More of an external sphincter defect and / or at any level of internal anal canal.
Have received treatment to faecal failure with bulking agents, neuromodulation or surgery.
Current anorectal tumors.
Current anal fissures.
Anorectal stenosis
Chronic pelvic or anorectal pain.

Show all 15Show fewer

Pregnant or 6 months postpartum.
Medical history of infection with Human Immunodeficiency Virus (HIV) or any severe immunocompromised state or therapy immunosuppressive.
Malignancies in remission for less than a year before the study. An exception to the basocellular carcinoma (BCC) in "remission" for less than a year.
Bleeding diathesis or current anticoagulant therapy.
Chemotherapy during the 6 months preceding the study.
Previous radiation with evidence of radiation injury in the treated area.
Participation in any other clinical study during the 3 months preceding the pre-study visit.
Patients with other serious disorders.
Patients with uncontrolled inflammatory disease or taking drugs prohibited in the protocol or active perianal disease.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

H. Juan Ramón Jiménez
Huelva, 21005
Fundación Jiménez Díaz
Madrid, 28040
Hospital Regional U de Málaga
Málaga, 29010
Hospital U Virgen del Rocio
Seville, 41013

Other trials in Spain

About this study

Official title: Study Phase I/II, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence

Read the detailed description

In the phase of recruitment, of 20 months of duration, there will be included 16 participants who will be randomized to one of the groups of intervention (8 patients group CMMAd / 8 patients group placebo). The phase of follow-up of every patient will be 12 months, though, provided that these patients are seen regularly in the study sites of the study, once concluded his follow-up will be continued to be able to obtain safety information and efficacy to 24 months.

Conditions: Faecal Incontinence
Being tested: Infusion of mesenchymal stem cells from adipose tissue, Infusion of placebo
Medical subject headings: Encopresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Infusion of mesenchymal stem cells from adipose tissueDrug
Infusion of placeboOther

Study groups in NCT02292628
Study group	Role	What they receive
Mesenchymal stem cells	Experimental	Autologous mesenchymal stem cells from the adipose tissue in an unique intralesional infusion with a dose of 40 million cells. Receives: Drug: Infusion of mesenchymal stem cells from adipose tissue
Ringer lactate solution	Placebo comparator	Ringer lactate solution Receives: Other: Infusion of placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Serious Adverse Events
Measured: 12 months

Secondary outcomes (4)

Changes in the faecal incontinence diary
Measured: 12 months
Anorectal manometry
Measured: 12 months
Jorge-Wexner Score
Measured: 12 months
Faecal Incontinence Quality of Life
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Sep 2017

First posted17 Nov 2014 (estimated)
Study startOct 2013
Primary completionSep 2017
Study completionSep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02292628
Sponsor's protocol ID: CMMAd/InFe/2011
Status last verified: Apr 2018
First submitted: 6 Nov 2014
Last updated: 17 Apr 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Active, not recruiting
F15 Recharge Free Axonics SNM System Clinical Study
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
RecruitingObservational study
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Fecal Incontinence
Recruiting
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)

All Faecal Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study Phase I/II, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence
ClinicalTrials.gov ID: NCT02292628
Acronym / sponsor ID: CMMAd/InFe/2011
Conditions: Faecal Incontinence
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
Collaborators: Iniciativa Andaluza en Terapias Avanzadas
Study start: Oct 2013
Primary completion: Sep 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 17 Nov 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Mesenchymal stem cells	Experimental	Drug: Infusion of mesenchymal stem cells from adipose tissueAutologous mesenchymal stem cells from the adipose tissue in an unique intralesional infusion with a dose of 40 million cells.
Ringer lactate solution	Placebo comparator	Other: Infusion of placeboRinger lactate solution

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males or females in the age group of 18-80 yrs.
A unique internal sphincter defect and / or external (no more than 100 º), at any level of the anal canal, of any cause (except those described in the exclusion criteria).
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.
Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent.

Key exclusion criteria (15 listed)

More of an external sphincter defect and / or at any level of internal anal canal.
Have received treatment to faecal failure with bulking agents, neuromodulation or surgery.
Current anorectal tumors.
Current anal fissures.
Anorectal stenosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Infusion of mesenchymal stem cells from adipose tissue	Drug	Mesenchymal stem cells
Infusion of placebo	Other	Ringer lactate solution

Primary outcome

Number of Serious Adverse Events
Time frame: 12 months

4 secondary outcomes

Changes in the faecal incontinence diary
Time frame: 12 months
Anorectal manometry
Time frame: 12 months
Jorge-Wexner Score
Time frame: 12 months
Faecal Incontinence Quality of Life
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.

Related trials for Faecal Incontinence

Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Active, not recruiting
F15 Recharge Free Axonics SNM System Clinical Study
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
RecruitingObservational study
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Fecal Incontinence
Recruiting
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fernando de la Portilla, Dr. principal investigator

Hospital U. Virgen del Rocio

Santiago Mera, Dr. principal investigator

Hospital Regional U de Málaga

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Serious Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02292628.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.