An investigator-led clinical trial has successfully treated its first patient in a study of BioTime’s (NYSE MKT: BTX) Premvia as a carrier for stromal vascular fraction cells (SVF) for the treatment of age-related volume loss in the face.
This is the first clinical trial to study Premvia in a purely cosmetic application. The objective of the investigator-led study is to evaluate the safety and performance of Premvia as a carrier for autologous SVF in non-HIV patients. The single-arm study is designed to evaluate 10 subjects who each receive a treatment of Premvia and SVF.
The study’s primary endpoint is meant to change in volume of each side of the face from baseline six months post treatment, with secondary endpoints being hemi-facial volume change at one, two, three and 12 months from baseline.
“Premvia has the potential to address the limitations that we see with autologous fat transfer,” Dr. Joel Aronowitz, a leading Beverly Hills-based plastic surgeon who is conducting the study, said in a statement.
Separately, BioTime reached agreement on terms to sublicense certain HyStem rights to Processa Pharmaceuticals for creation of a sustained-release delivery platform.
“This initiative will combine the expertise and experience of the Processa team with our HyStem platform, and together we hope to leverage the technology beyond the local delivery programs we are pursuing at BioTime,” said Adi Mohanty, co-CEO of BioTime.
“I believe that securing this potential sublicensing arrangement further validates and supports BioTime’s key strategic initiatives,” he added.