Trial Underway Testing Stem Cell Particles for Burns

Exosome illustration (NIH)

16 Aug. 2023. A clinical trial has begun testing an experimental treatment for burns using off-the-shelf therapeutic particles derived from human bone marrow stem cells. The study is sponsored and conducted by the biotechnology company Aegle Therapeutics Corp. in Woburn, Massachusetts, testing its biologic drug candidate code-named AGLE-102, developed for treating burns and rare skin disorders.

AGLE-102 is made of extracellular vesicles, also known as exosomes, tiny bubble-like particles emitted from cells, often carrying proteins or nucleic acids like DNA or RNA to nearby cells in the body. In this case, the extracellular vesicles are released by mesenchymal stem cells, so-called adult stem cells found in bone marrow that transform into connective tissue cells, including those found in bone, cartilage, muscle, and fat. The Aegle Therapeutics process is based on research by its scientific founder Evangelos Badiavas, professor of dermatology at University of Miami medical school, who studies mesenchymal stem cells as treatments for burns and other chronic wounds.

Aegle Therapeutics says extracellular vesicles emitted by mesenchymal stem cells contain messenger and micro-RNA molecules that promote paracrine signaling, which sends growth factor proteins to nearby cells. The company says its extracellular vesicles also transfer two types of collagen proteins needed for developing skin membranes, and unlike earlier attempts, are designed to promote healing without scarring or inflammatory responses. In addition, says Aegle, its process makes possible allogeneic or off-the-shelf nanoscale particles from extracellular vesicles derived from donated mesenchymal stem cells that go into AGLE-102 and other therapies.

Measure burn wound closure and skin regeneration

The company says the first patient in the early- and mid-stage clinical trial received a dose of AGLE-102. The study is enrolling 10 patients at two sites with deep second-degree burns, the most common type of burns that cause blisters, discolored or shiny skin, and pain. Participants are treated with AGLE-102 within 48 hours of the injury, then two more treatments about one and two weeks later. The trial has no control or comparison group.

The study team is looking primarily for adverse effects from AGLE-102 for up to a year following the treatments. The researchers are also measuring closure of burn wounds and other indicators of skin tissue regeneration, such as restoring pigmentation and hair growth, at eight weeks following treatment. And, the team is assessing blood pressure rates in participants’ treated and unburned skin with Doppler laser, for up to a year following treatments.

“This milestone,” says Aegle Therapeutics CEO Shelley Hartman in a company statement released through Cision, “highlights our commitment to advancing extracellular therapy as an important multi-faceted approach to treating severe dermatological and immune based conditions.” The company plans a similar clinical trial for AGLE-102 as a treatment for epidermolysis bullosa, a rare inherited disorder where skin is fragile and easily blisters, in the fourth quarter of 2023.

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