Mayo Clinic preclinical discovery triggers wound healing, skin regeneration

ROCHESTER, Minn. — Difficult-to-treat, chronic wounds in preclinical models healed with normal scar-free skin after treatment with an acellular product discovered at Mayo Clinic. Derived from platelets, the purified exosomal product, known as PEP, was used to deliver healing messages into cells of preclinical animal models of ischemic wounds. The Mayo Clinic research team documented restoration of skin integrity, hair follicles, sweat glands, skin oils and normal hydration.

Ischemic wounds occur when arteries are clogged or blocked, preventing important nutrients and oxygen from reaching the skin to drive repair. This groundbreaking study titled, “TGF-β Donor Exosome Accelerates Ischemic Wound Healing,” is published in Theranostics.

“This paper documents that PEP, an off-the-shelf, room-temperature-stable exosome, is capable of healing wounds that are depleted of adequate blood supply. Wounds healed with only a single application of exosome,” says Steven Moran, M.D., a Mayo Clinic plastic surgeon and senior co-author on the study. “I was surprised that this product regenerated healthy skin with normal biomechanical properties — not scar tissue. As this technology is now scaled and biomanufactured for clinical applications, it creates the potential for huge advancement in medical science and the field of plastic surgery.”

This study has laid the foundation for Food and Drug Administration approval to begin a first-in-class clinical trial to test safety of using the purified exosomal product for wound healing in patients. This research is supported by Mayo Clinic’s Center for Regenerative Medicine, which is a leader in advancing new, validated regenerative procedures from research into practice.

ROCHESTER, Minn. — Difficult-to-treat, chronic wounds in preclinical models healed with normal scar-free skin after treatment with an acellular product discovered at Mayo Clinic. Derived from platelets, the purified exosomal product, known as PEP, was used to deliver healing messages into cells of preclinical animal models of ischemic wounds. The Mayo Clinic research team documented restoration of skin integrity, hair follicles, sweat glands, skin oils and normal hydration.

Ischemic wounds occur when arteries are clogged or blocked, preventing important nutrients and oxygen from reaching the skin to drive repair. This groundbreaking study titled, “TGF-β Donor Exosome Accelerates Ischemic Wound Healing,” is published in Theranostics.

“This paper documents that PEP, an off-the-shelf, room-temperature-stable exosome, is capable of healing wounds that are depleted of adequate blood supply. Wounds healed with only a single application of exosome,” says Steven Moran, M.D., a Mayo Clinic plastic surgeon and senior co-author on the study. “I was surprised that this product regenerated healthy skin with normal biomechanical properties — not scar tissue. As this technology is now scaled and biomanufactured for clinical applications, it creates the potential for huge advancement in medical science and the field of plastic surgery.”

This study has laid the foundation for Food and Drug Administration approval to begin a first-in-class clinical trial to test safety of using the purified exosomal product for wound healing in patients. This research is supported by Mayo Clinic’s Center for Regenerative Medicine, which is a leader in advancing new, validated regenerative procedures from research into practice.

The research

The research team replicated wounds with low blood supply in large animal models. They treated some of the wounds with the purified exosomal product and compared them to wounds that were treated with the hydrogel alone. They found wounds treated with the purified exosomal product were able to heal with skin restored to its normal architecture.

“We found that this exosome therapy has the ability to enhance regeneration of blood vessels in damaged tissues. Without treatment, chronic ischemic wounds grow larger and more problematic,” says Ao Shi, Ph.D., a student in the Regenerative Sciences Training Program in Mayo Clinic Graduate School of Biomedical Sciences and first author.

Dr. Behfar is the co-founder of Rion LLC, which Mayo Clinic has licensed to manufacture the purified exosomal product. Mayo Clinic and Dr. Behfar have a financial interest in the technology referenced in this news release.

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About Mayo Clinic’s Center for Regenerative Medicine
Mayo Clinic’s Center for Regenerative Medicine seeks to integrate, develop and deploy new regenerative medicine products and services that continually differentiate Mayo’s practice to draw patients from around the world for complex care. Learn more on Mayo Clinic’s Center for Regenerative Medicine website.

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news. For information on COVID-19, including Mayo Clinic’s Coronavirus Map tracking tool, which has 14-day forecasting on COVID-19 trends, visit the Mayo Clinic COVID-19 Resource Center.

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