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