NCT01600755 is a Phase 1, PHASE2 clinical trial of Iltamiocel in Fecal Incontinence, sponsored by Cook MyoSite.

Who is sponsoring NCT01600755?

NCT01600755 is sponsored by Cook MyoSite.

What drugs are being tested in NCT01600755?

Interventions in NCT01600755: Iltamiocel.

What condition does NCT01600755 study?

NCT01600755 studies Fecal Incontinence.

Is NCT01600755 still recruiting?

NCT01600755 is currently completed. Last updated 16 February 2024.

Are results published for NCT01600755?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-16 · How we verify

NCT01600755

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Autologous Cell Therapy for Treatment of Fecal Incontinence

Completed Phase 1, PHASE2 Results posted Last updated 16 February 2024

What this trial tests

Phase 1, PHASE2 trial testing Iltamiocel in Fecal Incontinence in 53 participants. Completed in 27 October 2021.

Timeline

28 March 2013

Primary endpoint
27 October 2021

27 October 2021

Quick facts

Lead sponsor	Cook MyoSite
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	28 March 2013
Primary completion	27 October 2021
Estimated completion	27 October 2021
Sites	2 locations across United Kingdom, Canada

Drugs / interventions tested

Iltamiocel — full drug profile →

Conditions studied

Fecal Incontinence — all drugs for Fecal Incontinence →

Sponsor

Cook MyoSite — full company profile →

Who can join

18 and older, any sex, with Fecal Incontinence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Treatment-Related Adverse Events Primary · 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.

Study Product-related serious adverse events

Group	Value	95% CI
Iltamiocel	0

Study Product-related adverse events

Group	Value	95% CI
Iltamiocel	1

Injection procedure-related adverse events

Group	Value	95% CI
Iltamiocel	5

Biopsy procedure-related adverse events

Group	Value	95% CI
Iltamiocel	28

Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary) Secondary · 3, 6, and 12 months post-treatment

Median number of fecal incontinence (FI) episodes as assessed by 28-day FI diary.

Fecal incontinence diary at 3 months

Group	Value	95% CI
Iltamiocel	8	0 – 100

Fecal incontinence diary at 6 months

Group	Value	95% CI
Iltamiocel	10	0 – 206

Fecal incontinence diary at 12 months

Group	Value	95% CI
Iltamiocel	7	0 – 161

Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary) Secondary · 3, 6, and 12 months post-treatment

Median number of days with fecal incontinence (FI) episodes, as assessed by 28-day FI diary.

FI diary at 3 months

Group	Value	95% CI
Iltamiocel	7	0 – 28

FI diary at 6 months

Group	Value	95% CI
Iltamiocel	7	0 – 28

FI diary at 12 months

Group	Value	95% CI
Iltamiocel	5	0 – 28

Number of Participants With Categorical ≥50% Reduction in 28-day Fecal Incontinence Episodes Secondary · 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.

Fecal incontinence diary at 3 months

Group	Value	95% CI
Iltamiocel	17

Fecal incontinence diary at 6 months

Group	Value	95% CI
Iltamiocel	19

Fecal incontinence diary at 12 months

Group	Value	95% CI
Iltamiocel	22

Number of Participants With Categorical ≥75% Reduction in 28-day Fecal Incontinence Episodes Secondary · 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.

Fecal incontinence diary at 3 months

Group	Value	95% CI
Iltamiocel	7

Fecal incontinence diary at 6 months

Group	Value	95% CI
Iltamiocel	12

Fecal incontinence diary at 12 months

Group	Value	95% CI
Iltamiocel	16

Number of Participants With 100% Reduction in 28-day Fecal Incontinence Episodes Secondary · 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.

Fecal incontinence diary at 3 months

Group	Value	95% CI
Iltamiocel	1

Fecal incontinence diary at 6 months

Group	Value	95% CI
Iltamiocel	4

Fecal incontinence diary at 12 months

Group	Value	95% CI
Iltamiocel	10

Change From Baseline in Patient-reported Quality of Life (Fecal Incontinence Quality of Life (FIQL) Questionnaire) Secondary · 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

Change in FIQL Lifestyle scale at 3 months

Group	Value	95% CI
Iltamiocel	0.4	± 0.7

Change in FIQL Lifestyle scale at 6 months

Group	Value	95% CI
Iltamiocel	0.4	± 0.7

Change in FIQL Lifestyle scale at 12 months

Group	Value	95% CI
Iltamiocel	0.6	± 0.7

Change in FIQL Coping/Behavior scale at 3 months

Group	Value	95% CI
Iltamiocel	0.4	± 0.7

Change in FIQL Coping/Behavior scale at 6 months

Group	Value	95% CI
Iltamiocel	0.5	± 0.7

Change in FIQL Coping/Behavior scale at 12 months

Group	Value	95% CI
Iltamiocel	0.5	± 0.7

Change in FIQL Depression/Self Perception scale at 3 months

Group	Value	95% CI
Iltamiocel	0.3	± 0.7

Change in FIQL Depression/Self Perception scale at 6 months

Group	Value	95% CI
Iltamiocel	0.3	± 0.6

Change From Baseline in Patient-reported Fecal Incontinence Symptom Severity (Cleveland Clinic Incontinence Score (CCIS)) Secondary · 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.

Change in CCIS score at 3 months

Group	Value	95% CI
Iltamiocel	-2.2	± 3.0

Change in CCIS score at 6 months

Group	Value	95% CI
Iltamiocel	-2.0	± 2.8

Change in CCIS score at 12 months

Group	Value	95% CI
Iltamiocel	-2.9	± 2.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Iltamiocel

Serious: 4/53 (8%)

Deaths: 0/53

Serious adverse events (6 terms)

Reaction	System	Iltamiocel
Pneumonia	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Urosepsis	Infections and infestations	—
Nephrotic syndrome	Renal and urinary disorders	—
Sinus operation	Surgical and medical procedures	—
Small intestine obstruction	Gastrointestinal disorders	—

Other adverse events (11 terms — click to expand)

Reaction	System	Iltamiocel
Procedural pain	Injury, poisoning and procedural complications	—
Diarrhea	Gastrointestinal disorders	—
Lower respiratory tract infection	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Post procedural contusion	Injury, poisoning and procedural complications	—
Hypoesthesia	Nervous system disorders	—
Nasopharyngitis	Infections and infestations	—
Hemorrhoids	Gastrointestinal disorders	—
Proctalgia	Gastrointestinal disorders	—
Cystitis	Infections and infestations	—
Cough	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Pneumonia, Urinary tract infection, Urosepsis, Nephrotic syndrome, Sinus operation, Small intestine obstruction.

Data from ClinicalTrials.gov NCT01600755 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Progress on cell therapy for skeletal muscle disorders.
Azzag K, Perlingeiro RCR. · · 2026 · PMID 41871765 · DOI 10.1016/j.addr.2026.115859

Verify or expand the search:

Other trials of Iltamiocel

Trials testing the same drug.

NCT01893138 — Autologous Muscle Derived Cells for Female Urinary Sphincter Repair · Phase 3 · completed

Other recruiting trials for Fecal Incontinence

Currently open trials in the same condition.

NCT06532123 — Mechanisms of Improving Fecal Continence Muscles Motor Function · NA · recruiting
NCT05998187 — Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections · Phase 3 · recruiting
NCT06754189 — Safety and Performance of UCon Patch Electrode · NA · recruiting
NCT06562140 — Multidimensional Examination of Patients with Colorectal and Anal Cancer · recruiting
NCT06273046 — Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback · NA · recruiting

Other Cook MyoSite trials

Trials by the same sponsor.

NCT02291432 — Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery · Phase 1, PHASE2 · completed
NCT01893138 — Autologous Muscle Derived Cells for Female Urinary Sphincter Repair · Phase 3 · completed
NCT01382602 — Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study · Phase 3 · completed
NCT01008943 — Autologous Cell Therapy for Female Stress Urinary Incontinence · Phase 2 · completed
NCT00847535 — An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Inc · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01600755 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cook MyoSite
Last refreshed: 16 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01600755.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01600755

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (6 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Iltamiocel

Other recruiting trials for Fecal Incontinence

Other Cook MyoSite trials

Verify against primary sources