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

NCT03609905 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-09-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Liaocheng People's Hospital

    lead OTHER

Principal Investigators

  • Peng Yan, MD · Liaocheng People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2021-06-01
Completion
2021-12-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03609905 on ClinicalTrials.gov