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

Last updated: August 31, 2020
Sponsor: Liaocheng People's Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT03609905
lcsrmyy-yp1
  • Ages 18-65
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, 18-65 years old

  • Diagnosis of ulcerative colitis diagnosed at least 6 months earlier

  • Moderate or severe activity defined by a Mayo score

  • No serious infection, chronic diseases, diabetes and tuberculosis

  • Unefficient by using 5-ASA, glucocorticoid or azathioprine

  • Written informed consents were obtained from all subjects

  • Capable of good communication with researchers and follow the entire test requirements

  • Negative pregnancy test for women of childbearing potential (from menarche tomenopause)

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding women or cognitively impaired adults

  • History of malignant disease

  • Infectious colitis

  • Patients with known allergies to culture medium

  • Patients having participated in clinical trials with any investigational drug within 1month prior to enrolment in this study

  • Patients with suspicion of Crohn's enterocolitis, indeterminate colitis, ischaemiccolitis, radiation colitis, diverticular disease associated colitis, or microscopiccolitis

  • Patients with previous colectomy

  • Positive to one or more of the infectious disease panel

  • Treatment with surgery or biological treatment (infliximab or adamizumab) orCyclosporine or tacrolimus or mycophenolate in the 8 weeks prior to inclusion in thestudy

  • Presence of severe concomitant diseases

  • Patients with clostridium difficult or cytomegalovirus infection

Study Design

Total Participants: 50
Study Start date:
July 01, 2018
Estimated Completion Date:
December 01, 2021

Connect with a study center

  • Liaocheng city people's hospital

    Liaocheng, Shandong 0635
    China

    Active - Recruiting

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