Fecal IncontinencePhase 2/3MIASNCT01523522
Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence
A Phase 2/3 study testing Myoblast injection and saline solution injection in people with Fecal Incontinence, run by University Hospital, Rouen at 2 sites in France.
Trial summary
This project aims to offer autologous muscle-derived progenitor cell injection as an efficient mini-invasive surgical therapy that would be simple for the patient and could be used in a majority of cases, including in young women in the post-partum. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Myoblast injection and saline solution injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2012to Oct 2015
- Phase
- Phase 2/3
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 20 and 65 years
- severe fecal incontinence from at least three months
- Jorge et Wexner score ≥ 10
- incontinence refractory to medical treatment and to reeducation from at least three months
- incontinence due to lesion of the external anal sphincter
- incontinence without significant anal sphincter rupture or rupture ≤ 30% of circumference assessed by endo-anal ultra-sonography
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- integrity or not of the internal anal sphincter
- fecal incontinence with normal rectum capacity (maximum tolerable volume ≥ 150 ml assessed by ano-rectal manometry)
- fecal incontinence without associated rectal static disorder on defeco-MRI
- fecal incontinence without bilateral complete neuropathy assessed by electro-physiology
Who cannot join
- fecal incontinence with rupture > 30 % of the external anal sphincter
- fecal incontinence with bilateral lesions on the sacral nerves
- Crohn's disease or ulcerative colitis
- unstable type 1 or type 2 diabetes
- myopathy
- peripheral or central neurological diseases
Show all 12Show fewer
- treatment with laxatives, suppositories or enema
- practice of anal intercourse except if stopped during the study
- treatment with immunosuppressive or cytostatic drugs, CoA HMG reductase inhibitors, morphine derivatives
- treatment of constipation or rectal dyschesia
- pregnancy or breast-feeding,lack of effective contraception during the study (female)
- allergy to antibiotics (cephalexin, metronidazole)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Etude de l'efficacité et de la sécurité d'Injections Intra-sphinctériennes de Myoblastes Autologues Chez Des Patients Atteints d'Incontinence Anale sévère Par Insuffisance sphinctérienne
This project aims to offer autologous muscle-derived progenitor cell injection as an efficient mini-invasive surgical therapy that would be simple for the patient and could be used in a majority of cases, including in young women in the post-partum. This approach may provide efficient tissue repair of the striated anal sphincter which is not permitted by existing therapies. This innovative therapy may ultimately be proposed after failure of the common treatments and before an high-risk invasive surgical intervention. Besides, injection of muscle-derived progenitor cells in animals has shown very encouraging results of the sphincter function assessed ex vivo. Hence, a high benefit may be expected with this approach.
Read the detailed description
after verification of information and inclusion criteria. patients were randomized to treatment or placebo arms and receive the injections.
an evaluation of the function and quality of life are realized. after a period of 6 months, patients in the placebo arm receive the injection of myoblasts that have been preserved.
- Conditions
- Fecal Incontinence
- Being tested
- Myoblast injection, saline solution injection
- Keywords
- Fecal incontinence, Myoblast, Surgery
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myoblast injectionOther
Autologous myoblast injection in the anal sphincter
saline solution injectionProcedure or surgery
saline solution injection in anal sphincter
| Study group | Role | What they receive |
|---|---|---|
| myoblast injection | Active comparator | autologous myoblast Receives: Other: Myoblast injection |
| saline solution injection | Placebo comparator | saline solution injection in anal sphincter Receives: Procedure: saline solution injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of anal incontinence score
Measured: 6 months
Secondary outcomes (1)
Improvement of quality of life score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier BOYER, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523522
- Sponsor's protocol ID
- 2009/067/HP
- Acronym
- MIAS
- Status last verified
- Oct 2015
- First submitted
- 23 Jan 2012
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bisson A, Le Corre S, Joly-Helas G, Chambon P, Demoulins L, Jean L, Adriouch S, Drouot L, Giverne C, Roussel F, Jacquot S, Doucet C, Michot F, Lamacz M, Frebourg T, Flaman JM, Boyer O. Chromosomal instability but lack of transformation in human myoblast preparations. Cell Transplant. 2014;23(12):1475-87. doi: 10.3727/096368913X670192.
PubMed 25565635
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de l'efficacité et de la sécurité d'Injections Intra-sphinctériennes de Myoblastes Autologues Chez Des Patients Atteints d'Incontinence Anale sévère Par Insuffisance sphinctérienne
- ClinicalTrials.gov ID
- NCT01523522
- Acronym / sponsor ID
- MIAS / 2009/067/HP
- Conditions
- Fecal Incontinence
- Keywords
- Fecal incontinence, Myoblast, Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Feb 2012 (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.
This project aims to offer autologous muscle-derived progenitor cell injection as an efficient mini-invasive surgical therapy that would be simple for the patient and could be used in a majority of cases, including in young women in the post-partum. This approach may provide efficient tissue repair of the striated anal sphincter which is not permitted by existing therapies. This innovative therapy may ultimately be proposed after failure of the common treatments and before an high-risk invasive surgical intervention. Besides, injection of muscle-derived progenitor cells in animals has shown very encouraging results of the sphincter function assessed ex vivo. Hence, a high benefit may be expected with this approach.
Detailed description
after verification of information and inclusion criteria. patients were randomized to treatment or placebo arms and receive the injections.
an evaluation of the function and quality of life are realized. after a period of 6 months, patients in the placebo arm receive the injection of myoblasts that have been preserved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myoblast injection | Active comparator | Other: Myoblast injectionautologous myoblast |
| saline solution injection | Placebo comparator | Procedure: saline solution injectionsaline solution injection in anal sphincter |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age between 20 and 65 years
- severe fecal incontinence from at least three months
- Jorge et Wexner score ≥ 10
- incontinence refractory to medical treatment and to reeducation from at least three months
- incontinence due to lesion of the external anal sphincter
Key exclusion criteria (12 listed)
- fecal incontinence with rupture > 30 % of the external anal sphincter
- fecal incontinence with bilateral lesions on the sacral nerves
- Crohn's disease or ulcerative colitis
- unstable type 1 or type 2 diabetes
- myopathy
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 |
|---|---|---|
| Myoblast injectionAutologous myoblast injection in the anal sphincter | Other | myoblast injection |
| saline solution injectionsaline solution injection in anal sphincter | Procedure or surgery | saline solution injection |
Primary outcome
Improvement of anal incontinence score
Time frame: 6 months
1 secondary outcome
Improvement of quality of life score
Time frame: 6 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 23 Oct 2015.
- Derived from this study: PubMed 25565635Bisson A, Le Corre S, Joly-Helas G, Chambon P, Demoulins L, Jean L, Adriouch S, Drouot L, Giverne C, Roussel F, Jacquot S, Doucet C, Michot F, Lamacz M, Frebourg T, Flaman JM, Boyer O. Chromosomal instability but lack of transformation in human myoblast preparations. Cell Transplant. 2014;23(12):1475-87. doi: 10.3727/096368913X670192.
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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.
Olivier BOYER, PhD principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Myoblast injection and saline solution injection in people with Fecal Incontinence, run by University Hospital, Rouen at 2 sites in France.
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 10 inclusion and 12 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 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Improvement of anal incontinence score (time frame: 6 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 NCT01523522, which also lists 1 linked publication.
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 23 Oct 2015.