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According to the FDA, real-world data (RWD) are data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources, including:Electronic health records (EHRs) Claims and billing activities Product and disease registries Patient-generated data including in home-use settings Data gathered from other sources that can inform health status, such as mobile devicesAlone, RWD have limited applications, but when properly organized, integrated, and correlated against longitudinal outcomes, may become real-world evidence (RWE). The FDA defines RWE as “evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data.”RWE generation, therefore, requires a methodical application of robust analytics against proper sources of RWD deriving from routine clinical care.Why is Real-World Evidence Valuable?In healthcare, there’s a gap between traditional clinical research, such as double-blinded, placebo trials, and everyday clinical procedures, interventions, and office visits. This gap creates a growing discrepancy between studied outcomes against curated patient populations, and actual outcomes across a heterogenous population.RWE addresses those gaps by correlating RWD stemming from a larger, more genetically diverse, and therefore more broad-patient relevant population. As just one example, a medical manufacturer could more cost-effectively generate RWE to satisfy the following post-market obligations:Detecting adverse events for a new device.Comparing new products or treatments with existing options and the standard of care for different patient cohorts.Updating clinical guidelines.Complying with regulatory requirements.RWE has the potential to drive cost-efficiencies, address evidence-based gaps throughout the healthcare system, and ultimately drive more predictable, personalized patient outcomes.If you’re interested in learning more about how real-world data and real-world evidence could support your healthcare goals, talk to one of our experts.

In February 2020, RegenMed and StemMedical® signed a deal to create a Circle for their proprietary stem cell-enriched lipofilling method for breast, facial, buttock augmentation and artificial implant replacement where a mix of autologous fat and autologous laboratory-expanded stem cells ASC (adipose tissue-derived stem cells) is injected with approximately 100% fat graft survival.The Circle has two principal objectives:To provide StemMedical® with large registry of valuable patient data, helping to demonstrate the natural effectiveness of their expanded stem cell-enriched adipose material in achieving and maintaining volume over time.To provide StemMedical® patients with an engaging, automated follow up experience which presents their results, before/after images and obtains answers to efficient satisfaction surveys for a period of up to 10 years post-operatively.‍Demonstrational OnlyThis GDPR-compliant Circle is in currently in use by three StemMedical® licensed plastic surgeons and has already enrolled many of their patients. First patient follow-up results are a few months away.StemMedical® is first in the world to commercially offer stem cell-based products for the cosmetic industry and is setting its sights on expanding through select countries in Europe over the next few years, where the Circle will play a pivotal role in attracting practitioners and their patients to these novel, evidence-based procedures.To learn more information about StemMedical®, visit www.stemmedical.com.

Christian Jorgensen, M.D., Ph.D, and Rosanna Feirrera Lopez, M.D., of CHU Montpellier, Loïc Le Coz, M.D., of CosmaGap, and Marion Bertrand-Marchand M.D., of OC Santé, are forming a series of Circles aimed at standardizing orthobiologic treatments through real-world evidence. Unlike a traditional study, all clinicians will be free to use their professional judgment in the use of device, clinical protocol, and patient selection, but by aggregating and benchmarking their long-term patient outcomes, will begin answering key clinical questions surrounding various regenerative medicine produces.Their first Circle focused on Arthrose de Genou et traitement par PRP (or PRP for Knee OA) aims to answer key clinical questions surrounding the obtainment, processing, and delivery of PRP, including: PRP and Biological Products (Tubes + Centrifuge) Used Platelet and Leukocyte Quantification Factors Determine Indications/Contraindications for Use and Predictive Markers Injection Locations and Frequency Comparisons to Standard and Alternative Biological Approaches The collaborative is then deploying an engaging and standardized patient follow-up regimen to collect and correlate their aggregated patient outcomes to clinical data. Patients will be active participants, equally eager to see their results compared against others when opting for such elective and novel procedures.This collaborative, currently titled “Regenerative Medicine Services of France” is planning to enroll its first patient in mid-September and provide a three-month update by end of year. Though three months are still early in terms of long-term follow-up, the members intend to share their methods, opinions, early evidence and an open invitation to colleagues from within and outside France to join their mission.To learn more about RMSF or Circles, click here.

RegenMed is helping to coordinate a multi-national Circle to study the efficacy and safety of the use of platelet-rich plasma (PRP) and minimally manipulated cellular products (SVF and BMAC) for the treatment of various MSK pathologies. The initiative is spearheaded by Circle Founder, Maksim Alekseevich Strakhov, Associate Professor of the Department of Traumatology, Orthopedics and Military Field Surgery, Russian National Research Medical University, and will involve scientific and clinical collaborators from the Union State (Russia and Belarus), North America, EU, and various other regions.Benefits of joining this Circle include:Access to the inCytes™ platform in your native language, helping to automate the generation of relevant real-world data from your clinic;Best practice patient privacy, storage, and encryption methodologies to protect personal information from yourself and patients;Ability to aggregate and correlate, in a de-identified manner, data with your multi-national colleagues;Participation in regular community events, whereby collaborators can review data, share protocols, and help standardize approaches across their medical practices.Contact Us to Learn More or Participate

Dr. Matias Fernandez Viña, M.D, cPhD, counts among his titles: Assistant Professor of Universidad Abierta Interamericana of Medicine, Latin American Section Chief of American College of Regenerative Medicine, and Medical Director of REGENERÓN, among others. He is therefore both an expert and perpetual student of Regenerative Medicine and has recently turned his attention to the generation and interpretation of real-world data through RegenMed's Circles.Dr. Viña first selected a pathology (Knee OA) and patient-reported outcomes measure (KOOS + VAS) to begin gathering outcomes data from his patients. Second, he devised a clinically efficient, "real world" protocol to help correlate clinical factors to patient outcomes. Currently, his interest is in comparing two common treatment options, PRP and processed adipose, and using his custom-designed protocols to inform considerations on efficacy, safety, and costs of these novel treatments.If you would like to learn more about Dr. Viña's real-world data study, early results, or explore opportunities for collaboration, reach out today.