The Therapeutic Potential of Exosomes

In recent years, several universities and research hospitals have conducted small-scale phase I clinical trials using exosomes. So far, only a few companies have transitioned to human clinical trials. Testing a new treatment method in human is an important step from the laboratory bench to any new treatment used in the clinic.

On May 11, 2018, Aegle Therapeutics announced that the FDA has approved its first IND application to initiate clinical trials of exosomes for patients with severe second-degree burns. The company initiated a Phase 1/2a clinical trial of its leading product AGLE-102 at the end of 2018. This makes it the first extracellular vesicle (EV) company approved by the FDA to enter human clinical trials. Aegle has two products under development, AGLE-102 for burn treatment and AGLE-103 for the management of epidermolysis bullosa (EB).

On January 28, 2020, Exopharm announced its first administration in a human clinical trial, becoming the first company to test the ability of exosomes to heal wounds. The phase I study is testing Plexaris, the product of Exopharm, which is a cell-free platelet exosomal preparation that has shown regeneration effects in preclinical animal studies, improved wound healing and reduced scars.

On June 26, 2019, United Therapeutics announced that its phase I trial based on exosomes for the treatment of bronchopulmonary dysplasia (BDP) was approved. BDP is a common disease in preterm infants receiving assisted ventilation and supplemental oxygen. Recruitment has started, but the dosage has not yet been announced. The symptom of BDP is that the growth and development of the lungs are blocked, and the health effects can last into adulthood.

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