Cardiovascular disease remains the leading cause of morbidity and mortality around the world and patients with end-stage ischemic heart failure carry the highest morbid-mortality rate.
Although heart transplant improves the outcomes of selected patients, the donor heart availability has limited its widespread utilization. Autologous bone marrow mononuclear cells transplantation through intramyocardial injections has been used in very initial clinical trials with promising results for treating these patients.
Our study was carried out at Pró-Cardíaco Hospital with the financial support of the Filantropic Foundation for Teaching and Researching of Pró-Cardíaco Hospital (PROCEP), in Rio de Janeiro, Brazil. The catheter-based injection system (NOGA system, Cordis Johnson&Johnson) was handled by Dr Emerson Perin from Texas Heart Institute, Houston, who was the co-principal investigator in this study.
Twenty-one patients were enrolled in this clinical trial started in December 2001, which was conducted at Pró-Cardíaco Hospital, in Rio de Janeiro, Brazil, in a partnership with Texas Heart Institute, Houston, and the Federal University of Rio de Janeiro.
It is important to emphasize that this trial was preceded by experimental models developed in partnership with the Federal University of Rio de Janeiro, granted by the Brazilian Ministry of Science and Technology. The clinical trial was approved by the Hospital Pró-cardíaco ethics committee and the Brazilian Research Ethics Council.
All patients had severe ischemic heart failure not amenable to any revascularization procedure. Fourteen patients were submitted to injections of autologous bone marrow mononuclear cells into myocardial safely, as our previously published data. The seven other patients served as a comparison or control group, and did not receive injections up to one year follow up. Our main objective was to create new small vessels in myocardial areas that were not receiving enough blood supply and because of that were contracting badly.
According to our published results, the treated patients had a significant 71% reduction in the amount of cardiac muscle with impaired blood supply and an improvement in the mechanical function, compared to the control group.
We came to this ESC Congress to report results from a subgroup of 5 treated patients that were already listed for heart transplantation and we could observe the same benefit that was seen in the entire group, including functional capacity and quality of life improvement.