ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02442037
Recruitment Status : Unknown
Verified May 2015 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 13, 2015
Last Update Posted : May 15, 2015
Sponsor:
Collaborator:
Ivy Institute of Stem Cells Co. Ltd
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Biological: UCMSC group Other: Control group(Normal saline) Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Endoscopic improvement is assessed by UCEIS. [ Time Frame: Post first cell transplantation 6 months ]
    UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity.

  3. Level of C-reactive protein [ Time Frame: Post first cell transplantation: 3 weeks and months 1,3 and 6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442037


Contacts
Contact: Yan Liu, M.D. +86-010-66947473 13911798288@163.com

Locations
China
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences Recruiting
Beijing, China, 100071
Contact: Yan Liu    +86-010-66947473    13911798288@163.com   
Principal Investigator: Min Min, M.D.         
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Ivy Institute of Stem Cells Co. Ltd
Investigators
Study Chair: Bing Liu, M.D. 307-IVY Translational Medicine Center
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

Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02442037     History of Changes
Other Study ID Numbers: 307-IVY-SC-002
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: May 2015

Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
cellular therapy
active ulcerative colitis
phase 1/2 clinical study
human umbilical cord mesenchymal stem cell
allogeneic stem cell transplantation
UC

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases