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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Biological: UCMSC group
* Other: Control group(Normal saline)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCMSC group<br>Human umbilical cord MSCs are administrated to patients by three intravenous infusion | Biological: UCMSC group<br>* Human umbilical cord MSCs are transplanted three times by intravenous infusion(1×10^6/kg) ,once every week，a total of three times.<br>|
| Other: Control group(Normal saline)<br>Patients will receive normal saline at the same time points as that in experimental group. | Other: Control group(Normal saline)<br>* Normal saline in same volume as MSCs are transplanted to patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cellular therapy, active ulcerative colitis, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, allogeneic stem cell transplantation, UC