Doctors seek next phase for clinical trial
An Indiana-based company has completed the first phase of clinical trials using stem cells in plastic surgery procedures, and is negotiating with the U.S. Food and Drug Administration to move on to the second phase.
“As far as we know, no one else in the United States has been able to do this,” said Dr. Leonard Maliver, CEO of Antria. “We’re just a little company trying to do our best.”
Antria was formed in 2010 out of Maliver’s offices on Hospital Road, using Indiana Regional Medical Center’s laboratory. The company has developed and patented a system to isolate, remove and activate stem cells in fat tissue; because such stem cells have the ability to grow into anything — such as 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 new cartilage in a destroyed joint.
But the current effort is to use those stem cells in facial augmentation procedures, allowing the surgery to last. 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 and the procedure has to be done again.
But stem cells, the argument goes, would form new blood vessels, restoring oxygen to the fat cells and keeping them healthy.
Antria received permission to begin the first phase of clinical trials last March, proving simply that their procedure would not cause problems (for example, tumors or other growths) for the six patients enrolled in the trials out of the Greensburg office of Dr. Francis Johns.
The procedure lasts under two hours, and involves removing fat tissue from a patient; removing, condensing and activating the stem cells; inserting them back into the fat tissue and then using that tissue as filler in the facial augmentation surgery.
It’s been more than a month since the last surgery was performed, and “all our patients look beautiful,” Maliver said.
They are required to monitor the patients for six years, but after three months may move on to the second phase, enrolling more patients to prove that the procedure does that they expect it too.
They’re currently working with the FDA to receive approval, and while Maliver hopes to move on to the second phase within a year, it’s up to the FDA, he said.
Meanwhile, they’ve been invited to conferences for plastic surgeons in New York City and Florida to talk about their procedure, he said.
And he’s excited to have accomplished what larger companies with ties to universities and funding have not.
“We’re just a tiny company, just four partners, no university, just friends and family (funding us). We’re trying to get people to look at us and say, ‘this is the real deal,’” he said.