Chronic wounds difficult to treat in preclinical models healed with normal scar-free skin after treatment with an acellular product discovered at the Mayo Clinic. Derived from platelets, the purified exosomal product, known as PEP, has been used to deliver healing messages in cells of preclinical animal models of ischemic wounds. The Mayo Clinic research team documented restoration of the integrity of the skin, hair follicles, sweat glands, skin oils, and normal hydration.
Ischemic wounds occur when arteries become clogged or blocked, preventing important nutrients and oxygen from reaching the skin to cause repair. This groundbreaking study entitled “TGF-β donor exosome accelerates ischemic wound healing”, is published in Theranostic.
“This article shows that PEP, a commercially available exosome that is stable at room temperature, is able to heal wounds with insufficient blood supply. Wounds healed with just one exosome application, ”says Steven Moran, MD, a Mayo Clinic plastic surgeon and study co-lead author. “I was surprised that this product regenerates healthy skin with normal biomechanical properties – not scar tissue. As this technology is now scaled up and bioproduced for clinical applications, it creates the potential for tremendous advancement in medical science and the field of plastic surgery.
This study laid the groundwork for Food and Drug Administration approval to begin a first-rate clinical trial to test the safety of using the purified exosomal product for wound healing in patients. This research is supported by the Mayo Clinic Center for Regenerative Medicine, which is a leader in advancing new validated regeneration procedures from research to practice.
Chronic ischemic wounds are common in people with conditions such as diabetes, pressure sores, hardening of the arteries, traumatic injuries, or side effects of radiation therapy. Standard treatments for these wounds include bandage, topical gels, and surgery. Although these measures offer some relief, they often cannot completely close the wound. As a result, about 7 million people in the United States have wounds that don’t heal properly, and efforts to find solutions have turned into a multibillion-dollar industry, according to research funded by the National Institutes of Health. As the condition progresses, non-healing wounds lead to amputation of a limb.
The purified exosomal product is an extracellular vesicle that carries cargo from one cell to another, targeting exactly the tissues in need of repair. This technology is manufactured under strict quality control measures and formulated as a dry powder to allow long term storage at room temperature. In the operating room or at the patient’s bedside, the powder is mixed with a hydrogel solution on the spot and can be applied directly to the wound. Unlike cell products, it doesn’t need to be sent to an outside lab to be grown and scaled.
“What we are seeing with this technology is not only that the wound is closed, but also that the blood supply to the tissues is restored. Our effort which resulted in the development of this exosomal technology was to create a therapy which can be offered to all patients in need by eliminating the logistical limitations often seen with more traditional regenerative therapy, ”says Atta Behfar, MD, Ph.D., Deputy Director of Translation, Center for Medicine Mayo Clinic Regenerative and Lead Author. “Our research hopes to find out whether this may be a novel healing solution for patients with chronic non-healing wounds.” Dr Behfar is Director of the Regenerative Cardiac Medicine Program at Mayo Clinic Van Cleve, where the purified exosomal product was discovered.
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 treated with the hydrogel alone. They found that wounds treated with the purified exosomal product could heal with the skin restored to its normal architecture.
“We have found that this exosome therapy has the ability to improve the regeneration of blood vessels in damaged tissue. Left untreated, chronic ischemic wounds get bigger and more problematic, ”says Ao Shi, Ph.D., a student in the Regenerative Sciences training program at the Mayo Clinic Graduate School of Biomedical Sciences and first author.
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