Joint restoration with RECLAIM

A team of Mayo Clinic orthopedic and regenerative medicine researchers is developing a knee joint restoration procedure called REcycled CartiLage Auto/Allo IMplantation (RECLAIM). The project is led by Daniel B. F. Saris, M.D., Ph.D., an orthopedic surgeon at Mayo Clinic in Rochester, Minnesota.

RECLAIM is a one-stage innovative procedure for the knee that enables tissue growth and restoration of damaged cartilage in the joint.

In the RECLAIM procedure, cartilage is removed from the damaged knee and cartilage cells are extracted to the level of the chondron, which is the structural and functional unit of cartilage. These autologous chondrons from the patient are mixed with healthy donor (allogeneic) mesenchymal stem cells (MSCs). The mixture is placed into fibrin glue, which allows the surgeon to inject it into the damaged knee. This procedure enables the body to repair the damaged cartilage, something it otherwise wouldn't be able to do.

The RECLAIM joint restoration procedure was performed as an investigational new drug (IND) in a phase 1 clinical trial that ran from September 2018 to September 2024. Investigators hope to expand the clinical trial and to eventually use the procedure in other damaged joints.

RECLAIM FDA public disclosure

Dr. Saris, the Mayo Clinic sponsor-investigator, has been granted regenerative medicine advanced therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for RECLAIM.

This public disclosure of the expanded access policy for RECLAIM is being provided in accordance with section 561A(f)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDCA authorizes the FDA to oversee and regulate the production, sale and distribution of food, drugs, medical devices and cosmetics.

RECLAIM is not available on an expanded access basis. Get more information from ClinicalTrials.gov about the associated investigational new drug clinical trial.

RECLAIM is manufactured by the Center for Regenerative Biotherapeutics at Mayo Clinic in Rochester, Minnesota.

Mayo Clinic may revise this policy at any time.