Steadman Philippon Research Institute has been granted the prestigious Regenerative Medicine Innovation Project Investigator-Initiated Clinical Trials award from the National Institutes of Health. Steadman Philippon Research Institutes Chief Scientific Officer Johnny Huard, Ph.D. will serve as the principal investigator.
Marc J. Philippon, M.D., who serves as managing partner of The Steadman Clinic and co-chair of SPRI and Scott Tashman, Ph.D., director of biomedical engineering at SPRI, will serve as co-principal investigators. The clinical trials are expected to begin enrolling in the fall of 2020.
The award, administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, ranks as one of the most significant in SPRIs history, both in size and recognition. Given the potential of regenerative medicine to enhance human health and treat disease, the United States Congress included a provision in the 21st Century Cures Act a law passed in December 2016 to accelerate medical discovery and innovation to support the NIH-established Regenerative Medicine Innovation Project.
The Regenerative Medicine Innovation Project aims to accelerate the field by supporting clinical research on adult stem cells while promoting the highest standards for protecting patient safety during the conduct of research.
This is a really great honor for SPRI, said Huard in a news release. Past recipients of these RMIP awards have been Albert Einstein College of Medicine, Boston Childrens Hospital, Columbia University Health Sciences, Childrens Hospital of Philadelphia, Harvard University, University of Colorado Denver and Yale University.So, we are in very good company.
Huard first came to Vail in 2015 and has served as the director of the Center for Regenerative Sports Medicine in addition to his role as the institutes chief scientific officer.
The grant anticipates over $2.8 million from the NIH and requires a 1:1 match from SPRI over the next five years, pending availability of federal funds. The clinical trials and resulting publications and reports will take place over the next five years. A generous SPRI benefactor committed to fund the first year of the match, and Dr. Huard is hopeful that with the NIH matching the funds, more philanthropists will be inspired to become involved in this groundbreaking project.
Our donors have been so generous in supporting all that we do here at SPRI, Huard said. And I am very grateful and confident that we will raise the funds necessary to complete these trials over the next five years.
The trial is entitled, The Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis. Huard explains in laypersons terms:
The idea behind the trial is to delay osteoarthritis in the knee, Huard said. Our goal is to delay the need for that first knee replacement in a patient for as long as we can. Over time SPRI intends to expand this area of research to other joints including hip and shoulder.
This clinical trial is designed to determine whether senolytic and/or antifibrotic agents will improve the beneficial effect of bone marrow stem cells for the treatment of symptomatic knee osteoarthritis. The trial will include four groups, totaling 100 patients, to investigate the teams hypothesis that the use of these agents will improve patient outcomes.
One of the great things that I love about this particular clinical trial is that we are actively involving our orthopedic surgeons and our biomotion lab staff as well, Huard said. This will truly be a team effort over the next five years.
Those world-class surgeons are led by Dr. Philippon, considered one of the worlds foremost orthopedic surgeons. The biomotion lab is under the direction of Dr. Tashman. The contributions of these two leaders and the talented roster of surgeons, clinicians and technicians in their departments will be critical to the success of the upcoming clinical trials. SPRIs Center for Outcomes-Based Orthopaedic Research and its director, Grant Dornan, are also participating in this project by contributing the statistical outcomes.
Dr. Philippon is not only a world-class surgeon but he is also an innovator, Huard said. He always wants to improve and is still willing to try new things to enhance patient outcomes. Dr. Tashman is the same way. Like everyone here at SPRI and The Steadman Clinic, they are embracing the cutting-edge technology available to them and finding new and better ways to treat patients and, most importantly, reduce patients recovery time and get them back to their active lives as quickly and safely as possible.
Huard notes that the rare combination of a globally recognized research institute like SPRI and a world-class orthopedic surgery clinic like The Steadman Clinic in the same building is one of the key factors in the awarding of this RMIP grant.
Weve got something here in Vail that many other research institutes dont have, Huard said. We have one of the worlds finest orthopedic clinics right next door, working hand-in-hand with us every day.
Dr. Huard and Dr. Tashman along with Suzanne Liv Page, J.D., our director of grants and contracts have worked diligently to prepare and gain acceptance of this grant proposal from the NIH, Philippon said. Our surgeons here at The Steadman Clinic eagerly await the opportunity to participate in the trial. Johnny, Scott and their staff have put SPRI into position to undertake major trials and studies like this one and we are all very honored that the NIH has given SPRI this incredible opportunity.
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