Rion Aesthetics announced that the United States Food and Medicines Administration (FDA) has allowed a new research drug application (IND) to procession 1 initiated by the researcher to evaluate the purified exosome product (PEP) injected into the dermis.
The study is sponsored and carried out independently by the Beverly Hills Clinical Test Center and is being directed by John H. Joseph, MD, a double -certified facial plastic surgeon based in California.
Pep, a stable liophilized powder derived from human platelets, is a research product, developed by Rion, a clinical stage regenerative medicine company. PEP is evaluated in research for its possible effects on cellular processes related to tissue repair, including cell growth, angiogenesis, inflammation modulation and cell protection.
The essay initiated by the researcher will evaluate the safety and tolerability of PEP when they are injected intradermally into healthy adults subjected to planned elective abdominoplasty surgery. Rion Aesthetics is providing PEP, the research product and research support for this independent essay. After the assignment of the FDA of the IND application, the dosage of the first particles begged this month.
“This test marks an important step to expand the scientific understanding of PEP exosomes,” says Alisa Lask, CEO of Rion Aesthetics, in a statement. “We are proud to support independent scientific research in PEP as part of our commitment to advance innovation in regenerative aesthetics.”
The phase 1 clinical trial will register up to nine healthy adult participants undergoing abdominoplasty surgery. This essay is designed to evaluate the safety and tolerability of PEP Exosomes of platelets administered intradermically in healthy volunteers. Additional final points will include tissue analysis to evaluate PEP regenerative potential in biological markers such as collagen and elastin.