In an interview with Morrie Ruffin and Michael Werner of the Alliance of Regenerative Medicine published just recently in The Life Science Report, the ARM executives discuss their outlook for the regenerative medicine field and their predictions for the years ahead. It is an interesting read that touches on issues such as commercialization, regulatory compliance as well as commercial viability of current cell therapy companies. When asked about the main hurdles to the clinical acceptance, Michael Warner put it clearly:
“One of the challenges in this space is the issue of commercialization, which concerns manufacturing, scale-up and all the things required to make these new products available and successful.”
For the entire article, click here.
On the heels of the interview are two interesting papers on MSC therapy that have just appeared. The first is from the University of Miami Miller School of Medicine, published in Journal of the American College of Cardiology, titled “Effect of Aging on Human Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy Patients.” The paper investigated whether the therapeutic effect of culture-expanded mesenchymal stem cells persisted at 1 year in patients younger than 60 years and older than 60 years. Data was obtained by measuring absolute scar size at baseline and 1 year post-transendocardial stem cell injection (TESI), while functional capacity was measured. While the study is limited by the nature of the analytical methods used, as well as a conservative functional approach employed, the authors showed a difference in scar size at the end and beginning that did, however, not differ by age.
The main finding was that, no – age does not impart response to MSC therapy.
Elsewhere across the world, the Chinese Academy of Sciences this week announced the start of an important human MSC trial to damage injured spinal cord. The trial, for which 6 patients have been recruited, is testing an implant made of mesenchymal stem cells and a collagen collagen scaffold fibers that contains collagen binding brain-derived neurotrophic factor (BDNF).
While the first transplant was just performed, these are the very earliest days of the study, which is expected to recruit up to 30 patients in the upcoming stages, and the results of which will be closely monitored.
This is by no means the first MSC trial currently ongoing, but it is a landmark development both from a medical perspective as well as a reminder that across the world, MSC therapies are coming of age.