FDA approves phase 2 clinical trials of autologous adipose-derived stem cells
Antria announced it has gained FDA approval to begin phase 2 clinical trials using its autologous adipose-derived stem cells for plastic surgery.
The company is the first to receive FDA approval for such purposes, according to a company press release.
The process uses liposuction to extract the patient’s own fat cells, and within 1 hour, stem cells are created from that material. Next, clinicians inject the stem cells under the patient’s facial skin to reduce wrinkles, scars and sagging skin, according to the press release.
Unlike with other methods, this process does not involve artificial dermal fillers and non-augmented fat grafts, according to the release. In using the patient’s own cells, the company hopes to create a more natural appearance that will last longer.
A critical component to the process is the isolation of stem cells using the company’s proprietary product, Adipolyx — a collagen-based reagent that could also help patients suffering from arthritis, wound healing, ischemic limbs, multiple sclerosis, impotence and urinary incontinence, the release stated.
During the second phase of study, Antria plans to incorporate a larger participant group and is set to begin enrollment within the next 90 days in Gainesville, Fla.