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

Phase 1

• Conditions: Ulcerative Colitis

• Registration Number: NCT02442037
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

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.

Study Timeline

• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-13
• Last Update Submitted: 2015-05-14
• Last Update Posted: 2015-05-15
• Primary Completion: 2017-05
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical response (CDAI points)	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.	Post first cell transplantation 6 months	UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity.
Level of C-reactive protein	Post first cell transplantation: 3 weeks and months 1,3 and 6

Trial Locations

Locations (1)

Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences; 🇨🇳 Beijing, China