Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis
NCT ID: NCT02442037
Last Updated: 2015-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2015-05-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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UCMSC group
Human umbilical cord MSCs are administrated to patients by three intravenous infusion
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.
Control group(Normal saline)
Normal saline in same volume as MSCs are transplanted to patients.
Interventions
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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)
Normal saline in same volume as MSCs are transplanted to patients.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Ivy Institute of Stem Cells Co. Ltd
INDUSTRY
Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Bing Liu, M.D.
Role: STUDY_CHAIR
307-IVY Translational Medicine Center
Yan Liu, M.D.
Role: STUDY_DIRECTOR
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Min Min, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Locations
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Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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307-IVY-SC-002
Identifier Type: -
Identifier Source: org_study_id
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