The phase II prospective, double-blind, randomized, controlled clinical trial was conducted at 26 centers in the United States, and is part of a long-term collaboration between researchers at Northwestern University Feinberg School of Medicine and Baxter International Incorporated.
The objective of the trial was to determine whether delivery of autologous (meaning one's own) CD34+ stem cells directly into multiple targeted sites in the heart might reduce the frequency of angina episodes in patients suffering from chronic severe refractory angina, under the hypothesis that CD34+ stem cells may be involved in the creation of new blood vessels and increase tissue perfusion.
The research team mobilized and extracted stem cells from all participants before randomizing them to one of three treatment groups: low- or high-dose cell concentrations, or placebo, and administered the regimens in ten distinct sites in the heart tissue through a multi-point injection catheter.
At six months after treatment, patients in the low-dose treatment group reported significantly fewer episodes of angina than patients in the control group (6.8 versus 10.9 episodes per week), and maintained lower episodes at one year after treatment (6.3 versus eleven episodes per week).
"The concept of using one's own stem cells to treat disease is highly attractive to the medical community and this research is consistent with Baxter's commitment to driving scientific advances that can lead to promising new treatments for critically ill patients," said Doctor Norbert Riedel, Baxter's chief scientific officer. "These results provide important insights into the potential for these cells to be used in larger scale settings, and we look forward to moving into phase III studies in the near future to hopefully substantiate these results."
MEDICA.de; Source: Northwestern University