It’s been two years since Health Canada released a position paper clarifying their regulations on autologous cell therapy products.  Among their key requirements were redefining that “the process is the product” and that “products with proper process controls” could increase the probability that “products would be consistent in strength, quality and purity”.  Thus, autologous cell therapies are “drugs” and are subject to the specific provisions for drugs under the Act.  Platelet Rich Plasma, or PRP, falls within the exception zone of “lymphohematopoietic cells which are minimally manipulated and are intended for homologous use”. However, the fact that PRP is not currently regulated as a drug doesn’t mean the product yet delivers consistent strength, quality, or purity, nor does it consistently yield standardized outcomes for all patients.

Martin Lamontagne, M.D. of La Clinique de Physiatrie et de Médecine du Sport Rockland is out to answer these pervasive questions around PRP variability, dosing, and patient outcomes.  With the support of MDBiologix, and RegenMed’s inCytes™ platform, Dr. Lamontagne will begin capturing the long-term outcomes of his everyday PRP patients, including their pain and WOMAC outcomes measures up to one year post-injection.  Furthermore, he will be performing benchside characterization on his PRP products, yielding useful correlations between PRP dosage and his patient’s self-reported outcomes.  This information will help Dr. Lamontagne and his Canadian colleagues better predict and deliver optimal PRP outcomes, while also exploring possible procedural standards for other autologous cell therapies.

To learn more about Dr. Lamontagne’s study, and please contact info@physiatrie.ca