Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis (UCMSC-UC)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Biological: UCMSC group Other: Control group(Normal saline)||Phase 1 Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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 ]
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
|Contact: Yan Liu, M.D.||+email@example.com|
|Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences||Recruiting|
|Beijing, China, 100071|
|Contact: Yan Liu +86-010-66947473 firstname.lastname@example.org|
|Principal Investigator: Min Min, M.D.|
|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|