Regeneris Medical Uses Clinical Research IO Software For Anti-Aging Trial
CAMBRIDGE, MA- Regeneris Medical, a Massachusetts-based anti-aging research center, is sponsoring a series of trials to measure the efficacy of regenerative cellular therapies on a wide range of indications, including musculoskeletal conditions such as rheumatoid arthritis, degenerative joint disease and osteoarthritis as well as hair loss, neurologic and autoimmune disorders, lupus, multiple sclerosis, Parkinson's disease and stroke recovery.
The company is exploring the use of Stromal Vascular Fraction and Platelet Rich Plasma to stimulate production of regenerative stem cells, which can then trigger the body's natural healing processes.
"Using the power of your own cells to heal, regenerative medicine offers new hope for treating a host of diseases. Our study focuses on the use of stem cells and other cells found in one's own adipose (or fat) tissue to release growth factors which are known to help heal", said Ryan Welter, M.D., PhD, founder of Regeneris Medical.
The open-label trials plan to enroll a total of 300 patients. Regeneris Medical is developing a network of physician sites across the country in various specialties to enroll these patients.
Managing multiple sites, many of them naive to clinical research, was a challenge for Regeneris for this trial. "We looked at the traditional model whereby a CRA is hired to visit sites to review their paper source and source data verify against EDC entry," said Gabrielle Lewis, the trial's project manager. "However, the cost was prohibitive, and this model would have hampered our ability to provide the kind of real-time, hands-on oversight we wanted."
To solve the problem, the company chose Clinical Research IO as the source data platform. Launched in 2016, the CRIO system allows investigators and site staff to collect data electronically, on a tablet. Real-time alerts guide the user through the process, ensuring better quality data upfront.
"With CRIO, I can log in remotely and see the source data," said Lewis. "This allows us to perform QC on an ongoing basis, instead of every 6 weeks at a CRA visit." She points out that this type of real-time oversight is especially helpful when onboarding sites new to research.
Dr. Welter believes this nimble, technology-driven approach could be a future research model for start-ups. "So much innovation in medicine is done by small companies like us," he said. "These companies need a cost-effective solution to scale quickly. I believe eSource and companies like CRIO are the future of research."
Since 2009, Regeneris Medical has been a leader in patient care, research and education in the field of regenerative medicine. For more information, visit www.regenerismedical.com.
CRIO is the leading eSource solution for clinical research sites. Since its launch in September, 2016, it has signed up 90 research sites, and is now deployed on over 180 studies. For more information, visit www.clinicalresearch.io.