CompletedNCT02384499Updated Aug 13, 2018

Treatment of Fecal Incontinence Using Allogenic-Adipose-derived Mesenchymal Stem Cells: A Prospective, Dose Escalation, Randomized, Placebo-controlled, Parallel-group, Single-blind, Single-center Pilot Study

A Phase 1 interventional study of ALLO-ASC injection and Placebo in Fecal Incontinence, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-08-13.

Sponsored by Yonsei University · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 21
Allocation: Randomized
Ages: 19 Years and older
Sex: All

Study summary

Purpose: The investigators aimed to investigate the safety and efficacy in the treatment of fecal incontinence by injection of ALLO-ASC into the anal sphincter.
Method
1. Safety test of allogenic ASCs injection
2. Efficacy test of allogenic ASCs injection

Read the detailed description

Background: Fecal incontinence is a distressing condition with recurrent uncontrolled passage of fecal material. Although fecal incontinence is developed by multifactorial causes, treatments were limited in medical or surgical methods. According to the recent studies of stem cell regeneration, it is reported that human adipose-derived stem cells have plentiful capacity in muscle regeneration, which had the efficacy to treat Crohn's fistulas. Therefore, the investigators hypothesized that the capability of muscle regeneration of allogenic-adipose-derived mesenchymal stem cells (ALLO-ASC) can be used to treat degenerated anal sphincter, which leads to fecal incontinence.
Purpose:The investigators aimed to investigate the safety and efficacy in the treatment of fecal incontinence by injection of ALLO-ASC into the anal sphincter.
Method
1. Safety test of allogenic ASCs injection In the first year, the investigators will investigate the safety of ALLO-ASC injection by a dose escalation study. Patients are sequentially enrolled into three groups, which are composed of three patients each. They are treated with an injection of ALLO-ASC to the anal sphincter for 3x107 cells/ml (group 1), 6x107 cells/ml (group 2), 9x107 cells/ml (group 3), respectively. After receiving the ALLO-ASC injection, patients will receive a physical examination, a serologic and immunologic response test (CD4/CD8) with an assessment of the Wexner score, patient satisfaction survey, WHO toxicity scale, adverse events, anorectal manometry and endorectal ultrasound at 1, 4, 8 weeks, 4, 6, 9, and 12 months in the outpatient clinic. The response of ALLO-ASC injection is assessed at 8 weeks after an injection and the most effective dose is determined among the groups.
2. Efficacy test of allogenic ASCs injection In the second year, the investigators will assess the efficacy of the ALLO-ASC injection comparing the ALLO-ASC injection group and the placebo group (0.9% normal saline injection) by a randomized, open-label, single-blind design. Each group is composed of six patients. Both the clinical assessment and follow-up period are identical with the first-year protocol.

Conditions studied

Fecal Incontinence

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In context

Fecal Incontinence

312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.

This study's enrollment of 21 is below the median of 50 across 216 interventional studies indexed under Fecal Incontinence.

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Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

At least 19 years old
Patients who received either medical therapy or biofeedback for fecal incontinence for more than 2 months with Wexner score ≥ 8
Transanal ultrasonography: presents a continuous fashion of anal sphincter
Anal manometery: decreased anal pressures than normal level
Negative for urine β-hCG in the screening test
An informed consent form has been signed by the patient

Exclusion criteria

Exclusion Criteria:

Participation in another clinical trial within 30 days
History of anorectal surgery within the previous 6 months
History of malignant tumor surgery within the previous 5 years (except for carcinoma in situ)
Patients requiring anorectal surgical treatments
History of artificial sphincter surgery
History of vaginal delivery within 6 months
Medical history of variant Creutzfeld-Jakobs disease or related diseases
Allergy to bovine-derived materials, fibrin glue or anesthestics
Autoimmune disease
Active tuberculosis
Pregnant or breastfeeding women
Unwillingness to use contraceptive methods
Patients with inflammatory bowel disease
Alcohol or drug-abuse
Use of cytotoxic agents within 30 days
Patients who have severe constipation (\<2 times/week), anal fistula, rectal prolapse, spinal cord injury, multiple sclerosis, Parkinson's disease
Patients with one of hematologic disease, immunodeficieny, fever, acute disease or severe chronic disease

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 21 participants (actual)

Study arms

Experimental
ALLO-ASC group
Allogenic-adipose-derived mesenchymal stem cell (ALLO-ASC) with fibrin glue injection to the anal sphincter
Biological: ALLO-ASC injection
Placebo comparator
Normal saline group
0.9% normal saline with fibrin glue injection to the anal sphincter
Drug: Placebo

Interventions

BiologicalALLO-ASC injection
Allogenic-adipose-derived mesenchymal stem cells (ALLO-ASC) injection to the anal sphincter of patients with fecal incontinence
Also known as: ALLO-ASC
DrugPlacebo
0.9% normal saline with fibrin glue injection to the anal sphincter of patients with fecal incontinence
Also known as: Normal saline with fibrin glue injection

What researchers measure

Primary outcomes

Clinically measured abnormality of laboratory tests and adverse events
The investigators will assess the safety of allogenic-adipose-derived mesenchymal stem cell (ALLO-ASC) injection to the anal sphincter among the three experimental groups (group 1: 3x107 cells/ml; group 2: 6x107 cells/ml; group 3: 9x107 cells/ml)).
Time frame: one year (12 months)

Secondary outcomes

Satisfaction as measured by Wexner Score
Improvement of Wexner Score at 12 months compared to baseline per each group. (The investigators will assess the efficacy of the ALLO-ASC injection comparing the ALLO-ASC injection group and the placebo group (0.9% normal saline injection) by a randomized, open-label, single-blind design.)
Time frame: one year (12 months)

Study locations

1 site

Section of Colon and Rectal Surger, Department of Surgery, Yonsei University College of Medicine
Seoul, 135-720, Korea, Republic of

References and documents

Publications

White AB, Keller PW, Acevedo JF, Word RA, Wai CY. Effect of myogenic stem cells on contractile properties of the repaired and unrepaired transected external anal sphincter in an animal model. Obstet Gynecol. 2010 Apr;115(4):815-823. doi: 10.1097/AOG.0b013e3181d56cc5. PubMed 20308844 ↗
Parmar N, Kumar L, Emmanuel A, Day RM. Prospective regenerative medicine therapies for obstetric trauma-induced fecal incontinence. Regen Med. 2014;9(6):831-40. doi: 10.2217/rme.14.56. PubMed 25431918 ↗
Kang SB, Lee HN, Lee JY, Park JS, Lee HS, Lee JY. Sphincter contractility after muscle-derived stem cells autograft into the cryoinjured anal sphincters of rats. Dis Colon Rectum. 2008 Sep;51(9):1367-73. doi: 10.1007/s10350-008-9360-y. Epub 2008 Jun 7. PubMed 18536965 ↗
Lorenzi B, Pessina F, Lorenzoni P, Urbani S, Vernillo R, Sgaragli G, Gerli R, Mazzanti B, Bosi A, Saccardi R, Lorenzi M. Treatment of experimental injury of anal sphincters with primary surgical repair and injection of bone marrow-derived mesenchymal stem cells. Dis Colon Rectum. 2008 Apr;51(4):411-20. doi: 10.1007/s10350-007-9153-8. Epub 2008 Jan 26. PubMed 18224375 ↗
Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487. PubMed 19273960 ↗
Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236. PubMed 10813117 ↗
Park EJ, Kang J, Baik SH. Treatment of faecal incontinence using allogeneic-adipose-derived mesenchymal stem cells: a study protocol for a pilot randomised controlled trial. BMJ Open. 2016 Feb 17;6(2):e010450. doi: 10.1136/bmjopen-2015-010450. PubMed 26888731 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02384499
Lead sponsor: Yonsei University
Responsible party: Sponsor
First posted: Mar 10, 2015
Start date: Dec 2014
Primary completion: Jun 30, 2017
Completion: Jun 30, 2017
Last update: Aug 13, 2018

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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