Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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

Tracking Information
First Submitted Date  ICMJE May 6, 2015
First Posted Date  ICMJE May 13, 2015
Last Update Posted Date May 15, 2015
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • 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.
  • Endoscopic improvement is assessed by UCEIS. [ Time Frame: Post first cell transplantation 6 months ]
    UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity.
  • Level of C-reactive protein [ Time Frame: Post first cell transplantation: 3 weeks and months 1,3 and 6 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2015)
  • Clinical response (CDAI points) [ Time Frame: Post first cell transplantation: 3 w,1 m,3 m,and 6 months ]
  • Endoscopic improvement. [ Time Frame: Post first cell transplantation 6 months ]
  • Level of C-reactive protein [ Time Frame: Post first cell transplantation: 3 w,1 m,3 m,and 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis
Official Title  ICMJE Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • 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)
    Normal saline in same volume as MSCs are transplanted to patients.
Study Arms  ICMJE
  • Experimental: UCMSC group
    Human umbilical cord MSCs are administrated to patients by three intravenous infusion
    Intervention: Biological: UCMSC group
  • Control group(Normal saline)
    Patients will receive normal saline at the same time points as that in experimental group.
    Intervention: Other: Control group(Normal saline)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02442037
Other Study ID Numbers  ICMJE 307-IVY-SC-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Affiliated Hospital to Academy of Military Medical Sciences
Study Sponsor  ICMJE Affiliated Hospital to Academy of Military Medical Sciences
Collaborators  ICMJE Ivy Institute of Stem Cells Co. Ltd
Investigators  ICMJE
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
PRS Account Affiliated Hospital to Academy of Military Medical Sciences
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP