An Indian American doctor at a renowned research facility is heading a team that will conduct the first ever clinical trial on heart patients to evaluate the safety and feasibility of using stem cells to treat congestive heart failure.
The University of Pittsburgh Medical Center announced on Thursday that it is beginning the clinical trial of the procedure that will involve injecting a patient's own bone marrow-derived stem cells directly into the heart muscle.
The stem cell trial is one of the few that has been cleared by the US Food and Drug Administration to treat heart disease.
Because most patients in the trial will eventually receive transplants, the trial will afford researchers the first ever opportunity to examine a human heart treated with stem cells.
This should help solve some of the mystery about just how step cells work to improve heart function. Laboratory studies indicating that a subset of stem cells from bone marrow can generate new heart cells and blood vessels have spawned interest in performing clinical studies.
But till date there has been no research in humans that helps explain why such improvements take place once stem cells are introduced into the heart.
"People have questioned whether stem cells take on the functional characteristics of heart cells or blood vessels, or whether they help recruit other cells and growth factors that have the ability to help regenerate heart tissue," said Dr Amit N Patel, principal investigator of the clinical trial and director of UPMC's Center for Cardiac Cell Therapy.
"Our study presents the unique opportunity to examine the heart several months after stem cell injections when the patient's native heart is removed for organ transplantation," Patel said.
"We are hopeful we will find the answers to everyone's questions."
Patel's team will harvest bone marrow from the patient's hipbone and the cells believed to have the greatest therapeutic benefit will be isolated and later injected along with a small amount of the patient's plasma into the diseased heart.
The university said that the procedure will not take more than five minutes.
Depending on their weight, each patient will get between 25 and 45 million stem cells. UPMC said it plans to enroll five to ten patients for the trial.
