Three years after they started the application process, an Indiana-based group of doctors and researchers has been approved by the U.S. Food and Drug Administration to begin testing the use of stem cells during plastic surgery.
Dr. Leonard Maliver, CEO of Antria, said the group will begin to enroll patients for the first phase of clinical trials in the next few weeks.
“We’re the first company to get FDA approval to start doing clinical trials,” he said. “We just kept trying and trying.”
A spokesperson from the FDA said they do not comment on any applications or whether Antria is the first to be approved.
Antria, located on Hospital Road, is working to develop a process to remove adult stem cells from a patient’s fat tissue, condense and activate them, then insert them back into the patient. Because such stem cells have the ability to grow into anything — like blood vessels or cartilage — the idea is that they can be used to help the human body restore itself. Eventually, the researchers hope to show the stem cells can be used to restore circulation to a diabetic’s dead limb (the cells would form new blood vessels), or to grow knew cartilage in a destroyed joint.
But the clinical trial approved by the FDA is simpler: to improve facial augmentation procedures. Now, when a plastic surgeon uses fat tissue as a filler for a procedure, the lack of oxygen to the fat cells can cause them to die off and shrink over time. But stem cells, the argument goes, would form new blood vessels, restoring oxygen to the fat cells and keeping them healthy.
The first phase, approved by the FDA, involves six patients. Maliver said they will work out of Dr. Francis John’s office in Greensburg, and that the first phase simply proves that using stem cells will not cause harm.
Later, a second phase involving more patients would prove that they actually work, he said.
The process involves removing fat tissue through liposuction; separating the stem cells from the fat cells; condensing and activating them; then inserting them back into the tissue that will be used in the facial augmentation. From start to finish it takes less than two hours.
Antria formed in 2010 and, while applying to the FDA, has conducted pre-clinical trials testing the fat-derived stem cells in test tubes to show how they change and grow. They have also developed a chemical cocktail used to activate the stem cells that they hope to eventually sell as a kit to other companies.
For now, though, they’re focusing on the clinical trials.
“We’re celebrating, but now is the start of a lot more work,” Maliver said.