Researchers are evaluating a platelet-derived exosome product for its safety and possible regenerative impact on collagen and elastin.
Rion Aesthetics announced that the US Food and Drug Administration (FDA) has allowed an Investigational New Drug (IND) application to proceed for a phase 1 investigator-initiated trial evaluating Purified Exosome Product (PEP) injected into the dermis.
The study is sponsored and independently conducted by Clinical Testing Center of Beverly Hills and is being led by John H. Joseph, MD, a double board-certified facial plastic surgeon based in California.
PEP, a shelf-stable lyophilized powder derived from human platelets, is an investigational product, developed by Rion, a clinical-stage regenerative medicine company. PEP is being evaluated in research for its potential effects on cellular processes relating to tissue repair, including cell growth, angiogenesis, inflammation modulation, and cellular protection.
The investigator-initiated trial will evaluate the safety and tolerability of PEP when injected intradermally into healthy adults undergoing planned elective abdominoplasty surgery. Rion Aesthetics is providing PEP, the investigational product, and research support for this independent trial. Following FDA allowance of the IND application, dosing of the first participants began this month.
“This trial marks an important step in expanding the scientific understanding of PEP exosomes,” says Alisa Lask, CEO of Rion Aesthetics, in a release. “We’re proud to support independent scientific research into PEP as part of our commitment to advancing innovation in regenerative aesthetics.”
The phase 1 clinical trial will enroll up to nine healthy adult participants undergoing abdominoplasty surgery. This trial is designed to evaluate the safety and tolerability of intradermally administered, platelet-derived PEP exosomes in healthy volunteers. Additional endpoints will include tissue analyses to assess PEP’s regenerative potential on biological markers such as collagen and elastin.
Photo caption: Purified Exosome Product
Photo credit: Rion Aesthetics
