September 28, 2022
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 email@example.com
April 12, 2023
Practitioners are increasingly being asked, instructed and/or incentivized to join data registries. These collaborative solutions allow practitioners to capture, aggregate and correlate unique real-world data not native to their EMR/EHR systems, including patient-reported outcomes. There is no shortage of solutions, many with dizzying levels of features, integrations, pricing models and clinical specializations.
April 3, 2023
It has been our pleasure to know and work with Jimmy Sung, MD, JD, FACS, for over five years. In 2018, the concept of Tribeca Aesthetics was a mere dream. Within three years, however, Dr. Sung had acquired premium property in strategically located lower Manhattan, converted it into fully certified first-class medical space (including a surgical suite), and built a thriving evidence-based plastic surgery and aesthetic practice.