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

August 31, 2020 updated by: peng yan, Liaocheng People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Liaocheng, Shandong, China, 0635
        • Recruiting
        • Liaocheng city people's hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 to menopause)

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 1 month prior to enrolment in this study
  • Patients with suspicion of Crohn's enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, or microscopic colitis
  • Patients with previous colectomy
  • Positive to one or more of the infectious disease panel
  • Treatment with surgery or biological treatment (infliximab or adamizumab) or Cyclosporine or tacrolimus or mycophenolate in the 8 weeks prior to inclusion in the study
  • Presence of severe concomitant diseases
  • Patients with clostridium difficult or cytomegalovirus infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
interventions: The MSCs of 5×10*7 will be given in different sites within colonic submucosa at a total 100 ml with the use of the colonoscope. Once every week，a total of two times. Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used
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
Other: Control group
interventions:Conventional drug therapy (5-amino-salicylic acid or glucocorticoid) is used
Other: Conventional drugs
5-amino-salicylic acid or glucocorticoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity)
Time Frame: Baseline, 8 weeks
Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is defined as Ulcerative Colitis Endoscopic Index of Severity, with higher scores indicating more severe disease
Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in clinical response (CDAI points)
Time Frame: Baseline, 8 weeks
CDAI is defined as Clinical Disease Activity Index
Baseline, 8 weeks
To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time Frame: Baseline, 8 weeks
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status. It includes 10-item form of questions. Each question is scored on a Likert scale from 1 (worst) to 7 (best), scores from each item are summed to produce a total score, increased more than 3 scores were considered remission.
Baseline, 8 weeks
Histologic Evaluation of Ulcerative Colitis
Time Frame: Baseline, 8 weeks
A 10 to 20 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).
Baseline, 8 weeks
Immune response in ulcerative colitis.
Time Frame: Baseline, 1, 4, 8 weeks
A number of soluble mediators are detected, including proinflammatory cytokines (TNF, IFN-γ, IL-6.) and anti-inflammatory cytokines (IL-10, IL-4.).
Baseline, 1, 4, 8 weeks
Incidence of Treatment Adverse.
Time Frame: Baseline, 1, 4, 8 weeks
An AE was any untoward medical occurrence in a participant
Baseline, 1, 4, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaocheng People's Hospital

Investigators

  • Study Chair: Peng Yan, MD, Liaocheng People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 1, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lcsrmyy-yp1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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