Overview

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

Status:
Completed
Trial end date:
2017-06-30
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yonsei University
Treatments:
Fibrin Tissue Adhesive
Criteria
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:

- 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