NCT03609905

Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis

A Phase I/II Randomized, Controlled, Clinical Trial for Assessment of the Safety and Efficacy of Allogeneic Adipose Mesenchymal Stem Cells in Moderate to Severe Ulcerative Colitis Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Liaocheng People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Ulcerative colitis is a form of inflammatory bowel disease characterized by diffuse inflammation of the colonic mucosa. It affects the rectum and extends proximally along a variable length of the colon. Ulcerative colitis is a chronic condition with a relapsing remitting course. Mesenchymal stem cells (MSCs) are a subset of adult stem cells residing in many tissues, including bone marrow (BM), adipose tissue, umbilical cord blood. Recent experimental findings have shown the ability of MSCs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation and functional recovery of the damaged tissues. The purpose of our study is to evaluate safety and efficacy of the intracolonic injection by using a colonoscope of allogeneic adipose MSCs in patients with moderate active ulcerative colitis.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
BIOLOGICAL	Adipose-cord mesenchymal stromal cells (A-MSCs)	A-MSCs 5 x 10\~7 diluted on 100 mL of normal saline
OTHER	Conventional drugs	5-amino-salicylic acid or glucocorticoid

Timeline

• Start date: 2018-07-01
• Primary completion: 2021-06-01
• Completion: 2021-12-01
• First posted: 2018-08-01
• Last updated: 2020-09-02

Locations

1 site across 1 country: China