Fecal IncontinencePhase 1/2NCT01600755
Autologous Cell Therapy for Treatment of Fecal Incontinence
A Phase 1/2 study testing Iltamiocel in people with Fecal Incontinence, run by Cook MyoSite at 2 sites in 2 countries.
Trial summary
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Iltamiocel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Mar 2013to 27 Oct 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary symptoms of fecal incontinence, as confirmed by patient medical history and physical examination
- Wexner (Cleveland Clinic Incontinence Severity (CCIS)) score ≥ 9
- Etiology of fecal incontinence is related, at least in part, to external anal sphincter dysfunction
- Failed conservative treatment
Who cannot join
- Gracilis sling repair or insertion of an artificial sphincter
- Inflammatory Bowel Disease
- Significant rectocele or rectal prolapse
- History of radiation treatment to the anal sphincter or adjacent structures
- Less than 18 years of age
- Pregnant, breastfeeding, or plans to become pregnant during the course of the study
Show all 14Show fewer
- Neuromuscular disorder
- History of neoplasia within 5 years prior to enrollment, except for basal cell carcinoma, or is receiving or planning to receive anti-cancer medications
- Known bleeding diathesis or uncorrected coagulopathy
- Medical condition that would preclude treatment due to contraindications and/or warnings of concomitant medications or listed in the experimental product labeling
- Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy
- Participating in another investigational drug or device study
- Unable or unwilling to provide informed consent
- Unable or unwilling to commit to the follow-up procedures
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective Nonrandomized Study of Autologous Muscle Derived Cell (AMDC) Transplantation for Treatment of Fecal Incontinence
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.
Read the detailed description
This study is designed to test the safety and feasibility of iltamiocel (Autologous Muscle Derived Cells, AMDC) as a treatment for fecal incontinence in men and women. Iltamiocel therapy seeks to allow remodeling of the external anal sphincter in patients with fecal incontinence from either defined structural defects or a generalized weakening of the external anal sphincter.
- Conditions
- Fecal Incontinence
- Being tested
- Iltamiocel
- Keywords
- Cell Therapy, Autologous Cell Transplantation, Muscle-derived Cell, Anal Incontinence, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Urinary Incontinence
- Medical subject headings
- Fecal Incontinence, Encopresis, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IltamiocelBiological
Also called Autologous Muscle-Derived Cells (AMDC)
Single intrasphincteric injection of iltamiocel at a dose of 250 x 10^6 cells
| Study group | Role | What they receive |
|---|---|---|
| Iltamiocel | Experimental | AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intrasphincteric injection of 250 x 10^6 cells. Receives: Biological: Iltamiocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Related Adverse Events
Assessment of frequency and severity of adverse events related to study product and study procedures through 12 months following treatment of FI in adult male and female subjects.
Measured: 12 months
Secondary outcomes (7)
Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary)
Median number of fecal incontinence (FI) episodes as assessed by 28-day FI diary.
Measured: 3, 6, and 12 months post-treatment
Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary)
Median number of days with fecal incontinence (FI) episodes, as assessed by 28-day FI diary.
Measured: 3, 6, and 12 months post-treatment
Number of Participants With Categorical ≥50% Reduction in 28-day Fecal Incontinence Episodes
Number of participants with categorical ≥50% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary.
Measured: 3, 6, and 12 months post-treatment
Number of Participants With Categorical ≥75% Reduction in 28-day Fecal Incontinence Episodes
Number of participants with categorical ≥75% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary.
Measured: 3, 6, and 12 months post-treatment
Number of Participants With 100% Reduction in 28-day Fecal Incontinence Episodes
Number of participants with 100% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary.
Measured: 3, 6, and 12 months post-treatment
Change From Baseline in Patient-reported Quality of Life (Fecal Incontinence Quality of Life (FIQL) Questionnaire)
Mean change from baseline in patient-reported quality of life, as assessed by the Fecal Incontinence Quality of Life (FIQL) questionnaire. The FIQL is a validated, 29-item tool assessing the quality of life (QOL) of subjects with FI with four scales: Lifestyle (10 items, scored 0 to 4, with higher scores indicating a better QOL), Coping/Behavior (9 items, scored 0 to 4, with higher scores indicating a better QOL), Depression/Self-Perception (7 items, scored 0 to 4, with higher scores indicating a better QOL), and Embarrassment (3 items, scored 0 to 4, with higher scores indicating a better QOL).
Measured: 3, 6, and 12 months post-treatment
Change From Baseline in Patient-reported Fecal Incontinence Symptom Severity (Cleveland Clinic Incontinence Score (CCIS))
Mean change from baseline in patient-reported fecal incontinence symptom severity, as assessed by the Cleveland Clinic Incontinence Score (CCIS) questionnaire. CCIS is a validated 5-questions tool assessing the frequency and the type of incontinence episodes (solid, liquid, gas), pad use, and lifestyle alteration. Scored from 0 to 20, with lower scores indicating less severe symptoms.
Measured: 3, 6, and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study start28 Mar 2013
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook MyoSite
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manoj J Raval, MD, Principal investigator, St. Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600755
- Sponsor's protocol ID
- 09-025
- Status last verified
- Jun 2023
- First submitted
- 11 May 2012
- Last updated
- 16 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Knowles CH, Canestrari E, Jankowski RJ, Cardello K, Raval MJ. Safety and Efficacy of Iltamiocel Cellular Therapy for the Treatment of Fecal Incontinence. Results of a Phase 1/2 Study. Ann Surg. 2023 Dec 1;278(6):937-944. doi: 10.1097/SLA.0000000000005894. Epub 2023 May 5.
PubMed 37144409
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Nonrandomized Study of Autologous Muscle Derived Cell (AMDC) Transplantation for Treatment of Fecal Incontinence
- ClinicalTrials.gov ID
- NCT01600755
- Acronym / sponsor ID
- 09-025
- Conditions
- Fecal Incontinence
- Keywords
- Cell Therapy, Autologous Cell Transplantation, Muscle-derived Cell, Anal Incontinence, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Urinary Incontinence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Cook MyoSiteIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2013 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Posted 16 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.
Detailed description
This study is designed to test the safety and feasibility of iltamiocel (Autologous Muscle Derived Cells, AMDC) as a treatment for fecal incontinence in men and women. Iltamiocel therapy seeks to allow remodeling of the external anal sphincter in patients with fecal incontinence from either defined structural defects or a generalized weakening of the external anal sphincter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iltamiocel | Experimental | Biological: IltamiocelAMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intrasphincteric injection of 250 x 10^6 cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary symptoms of fecal incontinence, as confirmed by patient medical history and physical examination
- Wexner (Cleveland Clinic Incontinence Severity (CCIS)) score ≥ 9
- Etiology of fecal incontinence is related, at least in part, to external anal sphincter dysfunction
- Failed conservative treatment
Key exclusion criteria (14 listed)
- Gracilis sling repair or insertion of an artificial sphincter
- Inflammatory Bowel Disease
- Significant rectocele or rectal prolapse
- History of radiation treatment to the anal sphincter or adjacent structures
- Less than 18 years of age
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 |
|---|---|---|
| IltamiocelAlso: Autologous Muscle-Derived Cells (AMDC)Single intrasphincteric injection of iltamiocel at a dose of 250 x 10^6 cells | Biological | Iltamiocel |
Primary outcome
Number of Treatment-Related Adverse Events
Time frame: 12 months
Assessment of frequency and severity of adverse events related to study product and study procedures through 12 months following treatment of FI in adult male and female subjects.
7 secondary outcomes
Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary)
Time frame: 3, 6, and 12 months post-treatment
Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary)
Time frame: 3, 6, and 12 months post-treatment
Number of Participants With Categorical ≥50% Reduction in 28-day Fecal Incontinence Episodes
Time frame: 3, 6, and 12 months post-treatment
Number of Participants With Categorical ≥75% Reduction in 28-day Fecal Incontinence Episodes
Time frame: 3, 6, and 12 months post-treatment
Number of Participants With 100% Reduction in 28-day Fecal Incontinence Episodes
Time frame: 3, 6, and 12 months post-treatment
Change From Baseline in Patient-reported Quality of Life (Fecal Incontinence Quality of Life (FIQL) Questionnaire)
Time frame: 3, 6, and 12 months post-treatment
Change From Baseline in Patient-reported Fecal Incontinence Symptom Severity (Cleveland Clinic Incontinence Score (CCIS))
Time frame: 3, 6, and 12 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37144409Knowles CH, Canestrari E, Jankowski RJ, Cardello K, Raval MJ. Safety and Efficacy of Iltamiocel Cellular Therapy for the Treatment of Fecal Incontinence. Results of a Phase 1/2 Study. Ann Surg. 2023 Dec 1;278(6):937-944. doi: 10.1097/SLA.0000000000005894. Epub 2023 May 5.
- Individual participant dataSharing planned: No
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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.
Manoj J Raval, MD principal investigator
St. Paul's Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Iltamiocel in people with Fecal Incontinence, run by Cook MyoSite at 2 sites in 2 countries.
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 4 inclusion and 14 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 16 Feb 2024. 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 Canada, United Kingdom. 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. 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?
Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Treatment-Related 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 NCT01600755, 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 16 Feb 2024.