This is the first application in patients of lineage-guided stem cells for targeted regeneration of a failing organ, paving the way to development of next generation regenerative medicine solutions.
The multi-center, randomized Cardiopoietic stem cell therapy in heart failure (C-CURE) trial involved heart failure patients from Belgium, Switzerland and Serbia.
Patients in the control group received standard care for heart failure in accordance with established guidelines. Patients in the cell therapy arm received, in addition to standard care, cardiopoietic stem cells - a first-in-class biotherapeutic. In this process, bone marrow was harvested from the top of the patient's hip, and isolated stem cells were treated with a protein cocktail to replicate natural cues of heart development.
Derived cardiopoietic stem cells were then injected into the patient's heart.
"The cells underwent an innovative treatment to optimize their repair capacity," said Andre Terzic, M.D., Ph.D., study senior author and director of the Mayo Clinic Center for Regenerative Medicine.
"This study helps us move beyond the science fiction notion of stem cell research, providing clinical evidence for a new approach in cardiovascular regenerative medicine," the researcher stated.
Every patient in the stem cell treatment group improved. Heart pumping function improved in each patient within six months following cardiopoietic stem cell treatment. In addition, patients experienced improved fitness and were able to walk longer distances than before stem cell therapy.
"The benefit to patients who received cardiopoietic stem cell therapy was significant," Dr. Terzic said.
Mayo Clinic partnered with Cardio3 Biosciences, a bioscience company in Mont-Saint-Guibert, Belgium, for advanced product development, manufacturing scale-up, and clinical trial execution.
Results of the clinical trial appeared online of the Journal of the American College of Cardiology.