NCT01285297

Safety Study of Transmyocardial Revascularization (TMR) With Bone Marrow Aspirate (BMAC) for Angina Reduction

A Prospective, Multicenter, Single Arm Study of Transmyocardial Revascularization (TMR) Plus Bone Marrow Aspirate Concentrated (BMAC) Using the Cardiogenesis PHOENIX Combination Handpiece Delivery System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety of injecting autologous bone marrow concentrate with laser transmyocardial revascularization (TMR) for treatment of angina which cannot be treated by direct coronary intervention.

Detailed description

Recently published information suggests the delivery of concentrated autologous bone marrow, in combination with transmyocardial revascularization (TMR) may provide synergistic effects for the reduction of angina in patients who are not treatable with conventional coronary artery bypass or percutaneous coronary intervention. This safety and feasibility study is intended to confirm the work previously done at one hospital in a larger, multicenter setting. Patients who are candidates for TMR will be asked to participate.

Conditions

• Angina

Interventions

Type	Name	Description
BIOLOGICAL	Bone Marrow Aspirate Concentrate	Injection of up to 18 mL BMAC

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-01-28
• Last updated: 2015-08-19

Locations

2 sites across 2 countries: Russia, Spain