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The power of regenerative medicine to heal, and prevent, a broad range of diseases and conditions has been recognized by major governments and medical institutions around the world. Already fifteen years ago, the U.S. Department of Health and Human Services stated:‍“Regenerative medicine is the next evolution of medical treatments. Derived from the fields of tissue engineering, tissue science, biology, biochemistry, physics, chemistry, applied engineering and other fields, regenerative medicine is the first truly interdisciplinary field that utilizes and brings together nearly every field in science. This new field holds the realistic promise of regenerating damaged tissues and organs in vivo (in the living body) through reparative techniques that stimulate previously irreparable organs into healing themselves. Regenerative medicine also empowers scientists to grow tissues and organs in vitro (in the laboratory) and safely implant them when the body is unable to be prompted into healing itself.This revolutionary technology has the potential to develop therapies for previously untreatable diseases and conditions. Examples of diseases regenerative medicine can cure include diabetes, heart disease, renal failure, osteoporosis and spinal cord injuries. Virtually any disease that results from malfunctioning, damaged, or failing tissues may be potentially cured through regenerative medicine therapies. Having these tissues available to treat sick patients creates the concept of “tissues for life.”‘ [1]‍The U.S. Department of Defense invests heavily in regenerative medicine, as does California, New York and dozens of other public sector entities. [2] In a seminal paper published in the New England Journal of medicine, Scott Gottlieb, the former commissioner of the Food and Drug Administration, stressed the potential power of regenerative medicine:“Scientific advances have shown us that stem cells are indeed remarkably complex biologic entities. To complicate matters, the term “stem cells” has been used to describe a variety of cells that have the capacity to divide and differentiate, including hematopoietic stem cells and adipose-derived stem cells (mesenchymal stem cells). The potential benefits to human health have spurred major progress in stem-cell biology over the past several decades. The field has moved from characterization of the properties of these cells toward therapeutic applications.”In that same paper, however, Commissioner Gottlieb drew a sharp line between the “good actors” and the “bad actors” in the field.“Even in the absence of serious adverse events, the use of therapies that are of unproven efficacy is a disservice to patients and to public health. An increasing number of safe and effective therapies are becoming available on the basis of the findings of well-designed clinical trials. It is critical to focus on efforts to facilitate the development of such therapies, rather than propagating products with dubious clinical efficacy and possible risks.” [3]Unfortunately for most consumers and patients, it is difficult to distinguish between the “good” and the “bad” actors. As pointed out in a Scientific American article:“Advertisements and pseudo news articles promote stem cell treatments for everything from Alzheimer’s disease, autism and ALS, to cerebral palsy and other diseases. The claims simply aren’t true–they’re propagated by people wanting to make money off of a desperate and unsuspecting or unknowing public. Patients and their families can be misled by deceptive marketing from unqualified physicians who often don’t have appropriate medical credentials and offer no scientific evidence of their claims. In many cases, the cells being utilized are not even true stem cells.” [4]In short, bad actors are those product manufacturers or healthcare professionals who make claims about their products or services which are not supported by the evidence. A recent medical journal article found that 96% of online marketing by cell therapy centers contained at least one false or misleading claim. [5] In most instances, the consequences for a patient may be overspending – often unjustifiably large amounts — on a treatment which has no lasting benefit. In other cases, however, unsupported “cell therapy” – especially when coupled with improperly trained clinicians — lead to serious injury. [6] Both the F.D.A. and the state attorneys general are initiating enforcement actions against unscrupulous bad actors”.Conversely, “good actors” understand the scientific basis for the immunomodulatory, regenerative and reparative capabilities of the human body. They also understand where there is insufficient evidence to support a particular clinical claim or procedure. Equally important, such good actors are committed to clinical excellence in the diagnosis and delivery of a given regenerative medicine intervention, ongoing engagement with the patient throughout the clinical journey, and the collection and transparent patient communication of science-based evidence relating to each procedure.Regen Med has long helped practitioners, institutions and healthcare manufacturers achieve and maintain Good Actor status within Federal, State and EU regulatory environments. If you’re interested in learning more about our services or success stories, please contact us at info@rgnmed.com. Additional resources are provided below for convenience.‍[1] The full HHS report can be found here.[2] See for example the Armed Forces Institute of Regenerative Medicine, the California Institute for Regenerative Medicine, the Wake Forest Institute for Regenerative Medicine and New York State Stem Cell Science, to name only a few.[3] The full NEJM article can be found here.[4] The full article can be found here.[5] Journal of Bone and Joint Surgery, January 2, 2020. See here. See also this article in the Bone and Joint Journal.[6] See this article discussing how three women went blind after receiving a “stem cell” treatment at a Florida center.

Can Real World Evidence (RWE) now be considered a universal approach? For better or for worse, the stars seem to have aligned in its favor. In a world gripped by a crisis such as COVID-19, it is difficult to continue to run traditional clinical trials involving patient visits to clinics. Simultaneously, regulators are placing additional focus on the use of RWE to support regulatory decision making.Whether you are a pharma, OTC or device manufacturer, RWE can bolster your brands.RWE can contribute to achieving multiple objectives:Pragmatic clinical trials to support marketing authorizations.Approval of new indications for marketed products.Advantages in patient sub-groups not studied in the pivotal clinical trials.Development of clinical practice guidelines.Coverage decisions.Post-marketing surveillance and post-marketing clinical follow-up (ideally linked to product lifecycle management).RWE can come from various sources:Electronic health records (EHRs).Claims and billing activities.Clinical registries.However, the data from these sources is retrospective in nature. In Regen Med’s experience, the most balanced approach is:Burden-free capture of longitudinal patient outcomes using a web-based platform which comprises comparative analytics to correlate treatment factors and clinical profile.Contact the author (info@rgnmed.com) to share your RWE needs, and receive a brief demo on how we’ve helped numerous other companies capture, interpret and utilize real world evidence to further their growth.

Turnkey regenerative therapy standardization, remote patient follow-up and telemedicine solution designed to contribute substantively to management of the elective orthopedic surgery backlog.ObjectivesAn analysis recently published in JBJS concludes that it may take up to 16 months until health-care systems can return to performing the pre-pandemic volume of elective orthopedic surgery. Even in optimistic scenarios, there will be a cumulative global backlog of millions of surgical cases after the end of elective surgery deferment. To many, it may seem impossible to close the gap and planning for postpandemic recovery requires addressing the backlog reactively and proactively. However, enhancement of patient surgical throughput alone will not be sufficient.Greater utilization of remote patient monitoring and telemedicine can be valuable in overseeing patients in the backlog. Tools and protocols for an efficient and successful virtual orthopedic visit are being developed with, for example, patients being provided with virtual visit checklists so that they can confirm a number of items prior to the virtual examination.Alternative ambulatory treatments options can also make a substantive contribution. Despite that fact that regenerative medicine therapies for musculoskeletal conditions have been available for a number of years, many specialists are hesitant to fully embrace this therapeutic approach because of what they perceive as a lack of standardization which undermines their confidence in the clinical outcome. For example, systems used for the preparation of PRP are highly variable and the majority of publications do not report on platelet concentration. Therefore, if regenerative medicine is to attain its therapeutic potential, there is a need for standardization on various levels to optimize both outcomes for patients and returns for clinics. Key focus areas should be:Continuous but burden-free capture of longitudinal patient outcomes and requisite clinical protocol data.Detailed characterization of the regenerative therapy delivered.Comparative analytics to correlate treatment factors and clinical profile to patient outcomes.Compelling but fair and evidence-based communication of protocol results to prospective patients.Integration with other approaches for surgical backlog management, such as telemedicine.Regen Med’s inCytes™ platform can form the core of such a solution.ComponentsEvidence-based, regulatory-compliant Observational Protocols (OP’s) approved by an expert Clinical/Scientific Advisory Board.Web-based patient compilation of flexible ePRO surveys for remote engagement, feedback, and benchmarking.Logistics for characterization of regenerative medicine therapies in a qualified laboratory.inCytes™ Circles to aggregate clinical data with collaborators through AWS Cloud.Visual report builder correlating custom clinical data points against patient outcomes.Alerts for outlier patients.Configuration of a telemedicine platform and integration with other systems.Account management to provide support, including monitoring performance, patient engagement and communication, compliance rates, and new user training.ImplementationSelection of one or more condition-specific protocols.Completion of ePRO and e-Form design.Telemedicine configuration where needed.Activation of regenerative therapy characterization.Opening of patient enrolment.Creation of inCytes Circle(s) and invitation of additional members.Scheduling of patient engagement and education/training.Initial Comparative Analysis Meeting.Key performance indicatorsNumber of patients enrolled.Quantification of outcome/satisfaction improvement.Robustness of regenerative therapy characterization system.Pertinence of education and training.

According to the most recent KPMG/RAPS survey of 230 medical device manufacturers, 83% of respondents cited the clinical evaluation report (CER) requirements of the EU’s new Medical Device Regulation (MDR) as a challenge. While the 12-month delay to the date of application of the MDR provides invaluable breathing space for manufacturers to get in line with the revised post-marketing clinical follow-up (PMCF) and post-marketing surveillance (PMS) requirements, continued social distancing related to COVID-19 make data collection using traditional approaches more difficult.This scenario provides the opportunity for renewed focus with the objective of exploiting the extra time to gain broader advantage. Because PMS/PMCF must comprise performance data from humans and must extend over the entire lifetime of devices, coupling these activities to product lifecycle management would produce strategic sales/marketing and growth benefits.The generation of RWE, real world (clinical) evidence, is one approach that is gaining recognition. Regen Med’s inCytes™ platform allows delegation of remote data input to patients using any type of device, thereby overcoming historic hurdles, including data collection compliance by investigators as well as new barriers, such as COVID-19 social distancing. The capability to construct observational protocols using a combination of standard PROM’s and custom queries, to implement ad hoc scoring systems and to form Circles among multiple users, in addition to remote data entry by patients, has attracted numerous device manufacturers to Regen Med’s Solution.