NCT01299324

Retrograde Delivery of BMAC (Bone Marrow Aspirate Concentrate) for Congestive Heart Failure

Feasibility Study of Retrograde Delivery of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Patients Diagnosed With Congestive Heart Failure (CHF)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Harvest Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this feasibility study is to provide clinical data to demonstrate the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC) produced with the Harvest Bone Marrow Aspirate Concentrate System for treating patients diagnosed with congestive heart failure (CHF).

Detailed description

To demonstrate that the infusion of bone marrow nucleated cells into the coronary sinus is safe as assessed by adverse event records. To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina and heart failure as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT. To assess the effect of the infusion of bone marrow nucleated cells on heart function as measured by ejection fraction (EF) and left ventricular end-diastolic diameter (LVEDD) by ECHO. To assess the effect of the infusion of bone marrow nucleated cells on the area of ischemia as measured by myocardial SPECT studies and ECHO.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	BMAC infusion	Infusion of 60 mL of Bone Marrow Aspirate Concentrate

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-08-01
• Completion: 2013-10-01
• First posted: 2011-02-18
• Last updated: 2014-08-19

Locations

3 sites across 3 countries: Germany, India, Peru