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

Primary Purpose

Ulcerative Colitis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
UCMSC group
Control group(Normal saline)
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring cellular therapy, active ulcerative colitis, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, allogeneic stem cell transplantation, UC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of gastroenterology,Affiliated Hospital to Academy of Military Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

UCMSC group

Control group(Normal saline)

Arm Description

Human umbilical cord MSCs are administrated to patients by three intravenous infusion

Patients will receive normal saline at the same time points as that in experimental group.

Outcomes

Primary Outcome Measures

Safety will be determined by the assessment of major adverse events.
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

Clinical response (CDAI points)
CDAI is defined as Clinical Disease Activity Index.
Endoscopic improvement is assessed by UCEIS.
UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity.
Level of C-reactive protein

Full Information

First Posted
May 6, 2015
Last Updated
May 14, 2015
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Ivy Institute of Stem Cells Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02442037
Brief Title
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis
Acronym
UCMSC-UC
Official Title
Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Ivy Institute of Stem Cells Co. Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
cellular therapy, active ulcerative colitis, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, allogeneic stem cell transplantation, UC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UCMSC group
Arm Type
Experimental
Arm Description
Human umbilical cord MSCs are administrated to patients by three intravenous infusion
Arm Title
Control group(Normal saline)
Arm Type
Other
Arm Description
Patients will receive normal saline at the same time points as that in experimental group.
Intervention Type
Biological
Intervention Name(s)
UCMSC group
Intervention Description
Human umbilical cord MSCs are transplanted three times by intravenous infusion(1×10^6/kg) ,once every week，a total of three times.
Intervention Type
Other
Intervention Name(s)
Control group(Normal saline)
Intervention Description
Normal saline in same volume as MSCs are transplanted to patients.
Primary Outcome Measure Information:
Title
Safety will be determined by the assessment of major adverse events.
Description
Safety will be determined by the assessment of major adverse events defined as fever, allergy or any other intravenous infusion adverse events.
Time Frame
Within the six months after intravenous infusion
Secondary Outcome Measure Information:
Title
Clinical response (CDAI points)
Description
CDAI is defined as Clinical Disease Activity Index.
Time Frame
Post first cell transplantation: 3 weeks and months 1,3 and 6
Title
Endoscopic improvement is assessed by UCEIS.
Description
UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity.
Time Frame
Post first cell transplantation 6 months
Title
Level of C-reactive protein
Time Frame
Post first cell transplantation: 3 weeks and months 1,3 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Liu, M.D.
Phone
+86-010-66947473
Email
13911798288@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Liu, M.D.
Organizational Affiliation
307-IVY Translational Medicine Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yan Liu, M.D.
Organizational Affiliation
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Min Min, M.D.
Organizational Affiliation
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
City
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Liu
Phone
+86-010-66947473
Email
13911798288@163.com
First Name & Middle Initial & Last Name & Degree
Min Min, M.D.

12. IPD Sharing Statement

Learn more about this trial

Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis

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