August 29, 2019

Gerstner Regenerative Medicine Initiative: Tracking Outcomes and Supporting Clinical Trials

By Jen Schutz
Image of an outcomes registry tablet used during consultations.
Outcomes registry tablet used during consults.

One of the challenges of integrating regenerative medicine into daily patient care is that it is so new, there is not a lot of available data to consider when determining best practices. A recent grant will help track information on how patient do after clinical trials.

The Gerstner Regenerative Medicine Initiative, funded through a grant from The Louis V. Gerstner Jr. Fund at Vanguard Charitable, is leading the design and implementation of a regenerative medicine outcomes registry and supporting ongoing osteoarthritis research and clinical trials at Mayo Clinic.

Regenerative Evidence-Based Outcomes Registry
The Regenerative Evidence-Based Outcomes Registry (REBO) is a digital platform used to track patient experience and patient outcomes for regenerative medicine procedures. It is one of three aims of the Gerstner Regenerative Medicine Initiative. In addition to a data collection repository, REBO is designed to be a digital learning platform that can show prospective patients outcome data in terms of effective treatments based on clinical conditions and other factors in order to help guide patient decision making and provide greater opportunities to make regenerative therapies available elsewhere in the Mayo Clinic practice.

“In order to contribute to high-quality real-world data and real-world evidence, we have created the REBO registry to track patients over time,” says Shane Shapiro, M.D., associate professor of orthopedic surgery and medical director of the Regenerative Medicine Therapeutic Suites in Florida who heads the Gerstner Regenerative Medicine Initiative. “Unlike traditional outcomes registries, we include additional elements that incorporate ethics and social information related to health outcomes of these innovative therapies.”

This means that researchers can apply real-world data in addition to rigorous clinical study data to expedite understanding of treatments and further the development of regenerative medicine products while also using this information to inform patients about regenerative options.

“Clinical research trials are tightly controlled and often start with small patient numbers which will exclude a larger representation of our patient population,” says Dr. Shapiro. “There are many additional sources of real world data including the electronic health record, insurance claims and even data that patients are willing to share with their providers from their phones and devices.”

Dr. Shapiro and his team intend to combine their real-world data with ongoing clinical studies to advance regenerative medicine therapeutics. The data can also be pooled with that of other practitioners and investigators in the field.

Jennifer Arthurs ARNP handing a outcomes registry tablet to a patient
Jennifer Arthurs, ARNP, handing an outcomes registry tablet to a patient.

The registry is built on a digital platform that can be customized to the needs of the practitioner as well as the health care field as a whole. This includes the ability to analyze the effect of medical comorbidities as well as behavioral concerns and mental health. The registry also weaves several medical and humanities specialties while educating and informing patients.

One of the first studies to use the REBO registry will track patient outcomes of shoulder and hip procedures.

“Almost all regenerative medicine clinical research is being conducted with knees,” says Dr. Shapiro. “By tracking patient outcomes for other joints, we can learn more about these procedures without even conducting additional trials.”

Regenerative Therapies for Knee Osteoarthritis
In addition to the REBO registry, Dr. Shapiro, through the Gerstner Regenerative Medicine Initiative, is spearheading a study to develop evidence-based best practices for dosing and frequency of regenerative therapies for knee osteoarthritis. The trial uses stromal vascular fraction (SVF) cells, or stem cells from a patient’s own fat, to treat pain from knee arthritis.

“There are many clinics out there irresponsibly marketing SVF cells directly to patients without approval from FDA,” says Dr. Shapiro. “This is an important trial because it is one of the first using SVF cells conducted in a legitimate scientific fashion to determine safety and efficacy, with all of the appropriate regulatory approvals.”

In all, the Gerstner Family Grant supports five initiatives across Mayo Clinic’s Arizona, Florida and Minnesota sites. Two of the five initiatives funded through the grant are designated to advance patient care through enterprise-wide regenerative medicine research and clinical trials at Mayo Clinic. Read more about the Gerstner family donation on the Mayo Clinic News Network.  

Watch an interview with Dr. Shapiro’s on how the Mayo Clinic Center for Regenerative Medicine is collecting real-world data to help inform patients, courtesy of The Evidence Base:

Tags: Dr. Shane Shapiro, Gerstner Regenerative Medicine Initiative, osteoarthritis, Practice, Regenerative Evidence-Based Outcome Registry, regenerative medicine, stem cells

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