NCT02442037

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
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.
OTHER	Control group(Normal saline)	Normal saline in same volume as MSCs are transplanted to patients.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-05-01
• Completion: 2017-12-01
• First posted: 2015-05-13
• Last updated: 2015-05-15

Locations

1 site across 1 country: China