People who have suffered from severe burns may have a new treatment option, instead of having to undergo painful skin grafts that require anesthesia. New technology could make repairing skin as easy as misting cells from a gun-type device.
Created by New York biotech firm RenovaCare, the CellMist System incorporates groundbreaking cell research by harvesting a patient’s stem cells from a one square inch area of unwounded skin. The skin patch is then suspended in a water-based solution, and the SkinGun sprays the solution onto the wound. New skin then grows from the cellular level.
“We don’t modify the cells,” said Thomas Bold, an engineer and president and CEO of RenovaCare. “We don’t do anything with the cells. We just isolate them from the surrounding tissue, put them in a syringe within a water-based solution, and we spray them.
“What we’re doing is all natural,” he added.
The survival cells that shoot out of the patented SkinGun are crucial to the process because cells “injured” in the process of being sprayed out of the gun might not grow properly. But 97 percent of the cells in the syringe remain viable, so it creates a great success rate of healing the wound, according to Bold.
Not FDA-Approved, But Treatments Successful
The SkinGun has not yet been approved by the Food and Drug Administration (FDA), but experimental treatments have been done in Pennsylvania. The journal Burns published a case report, citing both experts inside and outside the company who said it would take years for the product to be commercially viable and available to the public. But post-treatment images seemed promising. Photos provided by the company showed that patients were left with very little scarring after receiving treatment.
“We’ve seen already a couple dozen patients, and we’re very happy about the results,” Bold said.
Dr. Jörg Gerlach, lead author of the case report, a professor in the department of surgery at the University of Pittsburgh, and who also receives royalties from RenoCare for his work, agreed that initial studies have been successful.
“Our work in Pittsburgh on the pre-product procedure really shows only good results, with now 47 patient treatments at UPMC Mercy Hospital Burn and Trauma Units,” said Gerlach. He added that he and his colleagues are “only now entering the phase of planning clinical studies with RenovaCare.”
Further Studies Necessary Before FDA Approval
Dr. Robert Glatter, an emergency physician at Lenox Hill in New York, believes the advances with CellMist and SkinGun are promising, but cautions that additional trials would have to be conducted before the device is used as a solution for burn treatments.
Gladder, who is not affiliated with RenovaCare said, “Human studies have shown that this is feasible, but it’s certainly experimental at this point.” And while the the SkinGun technology is an improvement over current stem cell research, results “need to be borne out in further studies” before it can be embraced by the burn center community.
But the first step involves SkinGun getting federal recognition. “Gaining FDA approval,” Bold said, “is what we are working on right now.”