NCT00820586

Intramyocardial Delivery of Autologous Bone Marrow

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

A randomized study to assess the safety, feasibility and effectiveness of direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells in patients with refractory angina pectoris.

Detailed description

Primary Endpoint: Incidence of major adverse cardiac events (MACE) at 30 days. MACE is defined as a combined endpoint of death, acute MI (Q-wave and non-Q wave), revascularization procedures (percutaneous or surgical), and peri-procedural complications (that is, left ventricular perforation with hemodynamic consequences requiring pericardiocentesis, and stroke). Incidence of MACE at 3, 6 and 12 months Secondary Endpoints: * Change in Canadian Cardiovascular Society (CCS) angina classification score from baseline to 12 months * Changes in the quality of life, as assessed according to the Seattle Angina Questionnaire * Change in exercise duration and exercise tolerance using standardized treadmill exercise testing from baseline, to 6 months and to 12 months * Cumulative number of hospitalizations for coronary ischemia and congestive heart failure at 12 months following treatment. * SPECT-chances in global and regional radionuclide perfusion at rest, peak stress, and redistribution for baseline to 1, 6 and 12 months * Change in angiographic collateral score at 6 months * Change in global and regional myocardial contractility (assessed by echocardiography) at baseline, 6 and 12 months.

Conditions

• Refractory Angina

Interventions

Type	Name	Description
PROCEDURE	Mononuclear bone marrow derived cells	Direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-01-01
• Completion: 2018-12-01
• First posted: 2009-01-12
• Last updated: 2012-02-02

Locations

1 site across 1 country: Italy