Trial · NCT01600755
Autologous Cell Therapy for Treatment of Fecal Incontinence
NCT01600755, Phase 1, Phase 2, Completed, Cook MyoSite; results first posted 2024-02-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Autologous Cell Therapy for Treatment of Fecal Incontinence. Trials, record NCT01600755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01600755
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Autologous Cell Therapy for Treatment of Fecal Incontinence
- NCT number
- NCT01600755
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Cook MyoSite
- Conditions
- Fecal Incontinence
- Interventions
- Iltamiocel
- First posted
- 2012-05-17
- Last updated
- 2024-02-16
- Results first posted
- 2024-02-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment-Related Adverse Events | 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. |
| Secondary | Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary) | 3, 6, and 12 months post-treatment | Median number of fecal incontinence (FI) episodes as assessed by 28-day FI diary. |
| Secondary | Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary) | 3, 6, and 12 months post-treatment | Median number of days with fecal incontinence (FI) episodes, as assessed by 28-day FI diary. |
| Secondary | Number of Participants With Categorical ≥50% Reduction in 28-day Fecal Incontinence Episodes | 3, 6, and 12 months post-treatment | Number of participants with categorical ≥50% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary. |
| Secondary | Number of Participants With Categorical ≥75% Reduction in 28-day Fecal Incontinence Episodes | 3, 6, and 12 months post-treatment | Number of participants with categorical ≥75% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary. |
| Secondary | Number of Participants With 100% Reduction in 28-day Fecal Incontinence Episodes | 3, 6, and 12 months post-treatment | Number of participants with 100% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary. |
| Secondary | Change From Baseline in Patient-reported Quality of Life (Fecal Incontinence Quality of Life (FIQL) Questionnaire) | 3, 6, and 12 months post-treatment | 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). |
| Secondary | Change From Baseline in Patient-reported Fecal Incontinence Symptom Severity (Cleveland Clinic Incontinence Score (CCIS)) | 3, 6, and 12 months post-treatment | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment-Related Adverse Events | 12 months | events | NUMBER | |
| SECONDARY | Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary) | 3, 6, and 12 months post-treatment | Incontinence Episodes/28 Days | MEDIAN | |
| SECONDARY | Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary) | 3, 6, and 12 months post-treatment | days with incontinence episodes | MEDIAN | |
| SECONDARY | Number of Participants With Categorical ≥50% Reduction in 28-day Fecal Incontinence Episodes | 3, 6, and 12 months post-treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Categorical ≥75% Reduction in 28-day Fecal Incontinence Episodes | 3, 6, and 12 months post-treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With 100% Reduction in 28-day Fecal Incontinence Episodes | 3, 6, and 12 months post-treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Baseline in Patient-reported Quality of Life (Fecal Incontinence Quality of Life (FIQL) Questionnaire) | 3, 6, and 12 months post-treatment | scores on scales | MEAN | |
| SECONDARY | Change From Baseline in Patient-reported Fecal Incontinence Symptom Severity (Cleveland Clinic Incontinence Score (CCIS)) | 3, 6, and 12 months post-treatment | scores on scales | MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment-Related Adverse Events | Iltamiocel | Study Product-related serious adverse events | 0 | events | |
| Number of Treatment-Related Adverse Events | Iltamiocel | Study Product-related adverse events | 1 | events | |
| Number of Treatment-Related Adverse Events | Iltamiocel | Injection procedure-related adverse events | 5 | events | |
| Number of Treatment-Related Adverse Events | Iltamiocel | Biopsy procedure-related adverse events | 28 | events | |
| Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary) | Iltamiocel | Fecal incontinence diary at 3 months | 8 | Full Range 0 to 100 | Incontinence Episodes/28 Days |
| Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary) | Iltamiocel | Fecal incontinence diary at 6 months | 10 | Full Range 0 to 206 | Incontinence Episodes/28 Days |
| Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary) | Iltamiocel | Fecal incontinence diary at 12 months | 7 | Full Range 0 to 161 | Incontinence Episodes/28 Days |
| Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary) | Iltamiocel | FI diary at 3 months | 7 | Full Range 0 to 28 | days with incontinence episodes |
| Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary) | Iltamiocel | FI diary at 6 months | 7 | Full Range 0 to 28 | days with incontinence episodes |
| Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary) | Iltamiocel | FI diary at 12 months | 5 | Full Range 0 to 28 | days with incontinence episodes |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Iltamiocel | 53 | |
| Overall Study | Iltamiocel Injection | Iltamiocel | 48 | |
| Overall Study | 3-Month Follow-Up | Iltamiocel | 48 | |
| Overall Study | 6-Month Follow-Up | Iltamiocel | 48 | |
| Overall Study | 12-Month Follow-Up | Iltamiocel | 47 | |
| Overall Study | COMPLETED | Iltamiocel | 47 | |
| Overall Study | NOT COMPLETED | Iltamiocel | 6 |
Source ClinicalTrials.gov
Adverse events17
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Iltamiocel | 8 | 53 | 9 |
| other | Hemorrhoids | Gastrointestinal disorders | Iltamiocel | 3 | 53 | 3 |
| other | Proctalgia | Gastrointestinal disorders | Iltamiocel | 3 | 53 | 4 |
| other | Cystitis | Infections and infestations | Iltamiocel | 3 | 53 | 4 |
| other | Lower respiratory tract infection | Infections and infestations | Iltamiocel | 6 | 53 | 6 |
| other | Nasopharyngitis | Infections and infestations | Iltamiocel | 4 | 53 | 4 |
| other | Urinary tract infection | Infections and infestations | Iltamiocel | 5 | 53 | 7 |
| other | Post procedural contusion | Injury, poisoning and procedural complications | Iltamiocel | 5 | 53 | 5 |
| other | Procedural pain | Injury, poisoning and procedural complications | Iltamiocel | 14 | 53 | 14 |
| other | Hypoesthesia | Nervous system disorders | Iltamiocel | 5 | 53 | 5 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Iltamiocel | 0 | 53 |
| Total, other adverse events | Iltamiocel | 31 | 53 |
| Total, serious adverse events | Iltamiocel | 4 | 53 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37144409 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01600755
GET https://conductscience.org/api/trials/v1/NCT01600755/results?page=2