NCT02384499

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

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

• Fecal Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	ALLO-ASC injection	Allogenic-adipose-derived mesenchymal stem cells (ALLO-ASC) injection to the anal sphincter of patients with fecal incontinence
DRUG	Placebo	0.9% normal saline with fibrin glue injection to the anal sphincter of patients with fecal incontinence

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2015-03-10
• Last updated: 2018-08-13

Locations

1 site across 1 country: South Korea