Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis (UCMSC-UC)

May 14, 2015 updated by: Affiliated Hospital to Academy of Military Medical Sciences

Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.

Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.

Thirty patients will be selected and randomized into two groups: the first group of 15 patients will receive a sole injection of UC-MSC and the remaining 15 patients will comprise the control group.

Every patient will maintain their standard treatment of active ulcerative colitis, with maximum tolerated dosage without side effects.

The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1 week, 1 week-2 week,2 week-3 week, 3 week-1 month, and 3 month-6 months.

Clinical results will be analyzed after completion of 6 months of followup.

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Locations

  • China
      • Beijing, China, 100071
        • Recruiting
        • Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The diagnosis of active UC must have been confirmed by endoscopic and histological evidence.
  • With mild and moderate disease.
  • Men and women 18-65 years of age.
  • Signed informed consent
  • Capable of good communication with researchers and follow the entire test requirements

Exclusion Criteria:

  • Patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome.
  • With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease.
  • Abnormal hepatic or renal function
  • Prior history of malignancy
  • Pregnant or unwilling to practice contraceptive therapy or breast feeding females

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UCMSC group
Human umbilical cord MSCs are administrated to patients by three intravenous infusion
Biological: UCMSC group
Human umbilical cord MSCs are transplanted three times by intravenous infusion(1×10^6/kg) ,once every week，a total of three times.
Other: Control group(Normal saline)
Patients will receive normal saline at the same time points as that in experimental group.
Other: Control group(Normal saline)
Normal saline in same volume as MSCs are transplanted to patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety will be determined by the assessment of major adverse events.
Time Frame: Within the six months after intravenous infusion
Safety will be determined by the assessment of major adverse events defined as fever, allergy or any other intravenous infusion adverse events.
Within the six months after intravenous infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response (CDAI points)
Time Frame: Post first cell transplantation: 3 weeks and months 1,3 and 6
CDAI is defined as Clinical Disease Activity Index.
Post first cell transplantation: 3 weeks and months 1,3 and 6
Endoscopic improvement is assessed by UCEIS.
Time Frame: Post first cell transplantation 6 months
UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity.
Post first cell transplantation 6 months
Level of C-reactive protein
Time Frame: Post first cell transplantation: 3 weeks and months 1,3 and 6
Post first cell transplantation: 3 weeks and months 1,3 and 6

Collaborators and Investigators

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

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Collaborators

Ivy Institute of Stem Cells Co. Ltd

Investigators

  • Study Director: Yan Liu, M.D., Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
  • Principal Investigator: Min Min, M.D., Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences

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

May 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

May 15, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-IVY-SC-002

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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