NCT02439541

Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy

Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.

Detailed description

Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study. Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention. Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects. The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months. Clinical results will be analyzed after completion of 12 months of followup.

Conditions

• Chronic Ischemic Heart Disease
• Heart Failure
• Angina

Interventions

Type	Name	Description
BIOLOGICAL	UCMSC group	Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10\^7)

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2015-05-08
• Last updated: 2016-03-16

Locations

1 site across 1 country: China