NCT01508910

Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina

A Prospective, Randomized, Double-blinded, Active-control and Unblinded Standard of Care (SOC) Controlled Study to Determine the Efficacy and Safety of Targeted Intramyocardial Delivery of Autologous CD34+ Cells (Auto-CD34+ Cells) for Increasing Exercise Capacity During Standardized Exercise Testing in Subjects With Refractory Angina Pectoris and Chronic Myocardial Ischemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Lisata Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.

Conditions

• Chronic Myocardial Ischemia
• Refractory Angina Pectoris
• Advanced Coronary Heart Disease

Interventions

Type	Name	Description
BIOLOGICAL	Auto-CD34+ cells	10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells
BIOLOGICAL	Placebo: Diluent used to suspend Auto-CD34+ cells	10 intramyocardial injections of 0.2 mL per injection site of placebo
OTHER	Standard of care	Standard of care for refractory angina

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2012-01-12
• Last updated: 2018-12-19
• Results posted: 2017-02-15

Locations

41 sites across 1 country: United States