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| Name | Class |
|---|---|
| Ivy Institute of Stem Cells Co. Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCMSC group | Experimental | Human umbilical cord MSCs are administrated to patients by three intravenous infusion |
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| Control group(Normal saline) | Other | Patients will receive normal saline at the same time points as that in experimental group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCMSC group | Biological | Human umbilical cord MSCs are transplanted three times by intravenous infusion(1×10^6/kg) ,once every week,a total of three times. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within the six months after intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response (CDAI points) | CDAI is defined as Clinical Disease Activity Index. | Post first cell transplantation: 3 weeks and months 1,3 and 6 |
| Endoscopic improvement is assessed by UCEIS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Liu, M.D. | Contact | +86-010-66947473 | 13911798288@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Liu, M.D. | 307-IVY Translational Medicine Center | Study Chair |
| Yan Liu, M.D. | Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences | Recruiting | Beijing | 100071 | China |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Control group(Normal saline) | Other | Normal saline in same volume as MSCs are transplanted to patients. |
|
UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity.
| Post first cell transplantation 6 months |
| Level of C-reactive protein | Post first cell transplantation: 3 weeks and months 1,3 and 6 |
| Min Min, M.D. | Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences | Principal Investigator |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |