Patient's stem cells are harvested, treated, sprayed on a burn with a SkinGun
Nearly 500,000 burn injuries require medical treatment each year
An experimental technology offers new hope to patients who have suffered a severe burn.
The product, from New York biotech firm RenovaCare, is rooted in cutting-edge stem cell research. The CellMist System harvests a patient’s stem cells from a small area of unwounded skin (usually one square inch) and suspends them in a water-based solution. The SkinGun sprays the solution onto the wound, where new skin begins to grow at 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 of cells shooting out of the SkinGun is instrumental, since cells “injured” in the process of spraying might not grow properly. According to Bold, 97% of the cells in the syringe remain viable, and so the chances of healing the wound are great.
Feasible but experimental
Though the patented product has not been approved by the Food and Drug Administration, experimental treatments (PDF) have been conducted in Pennsylvania.
“We’ve seen already a couple dozen patients, and we’re very happy about the results,” Bold said.
A case report was published in the journal Burns, though experts outside the company as well as insiders say it may take years to commercialize the product. Photos from the company show remarkably little scarring after treatment.
“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 Dr. Jörg Gerlach, lead author of the case report and a professor in the department of surgery at the University of Pittsburgh. He added that he and his colleagues are “only now entering the phase of planning clinical studies with RenovaCare.”
Gerlach receives royalties from RenovaCare for his work.
Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York, believes CellMist and SkinGun are promising, based on his knowledge of existing studies as well as one ongoing human trial in Argentina using stem cells to heal wounds.
“Human studies have shown that this is feasible, but it’s certainly experimental at this point,” said Glatter, who is not affiliated with RenovaCare. He added that the SkinGun technology is an improvement on current stem cell research, though the results “need to be borne out in further studies” before it can be embraced by the burn center community.
Though a lot of stem cell research for use in healing burns is happening now, “unfortunately, there are very few big randomized controlled studies to date,” noted Dr. Tom Rohrer, a dermatologic surgeon and board member of national organizations including the American Society for Dermatologic Surgery and the American Society for Laser Medicine and Surgery.
“Researchers have used stem cells from bone marrow, fat and skin cells,” said Rohrer, who is not affiliated with RenovaCare. “It appears as if the stem cells from bone marrow and fat work better than those from the skin, but it is a bit too early to tell.”
“Gaining FDA approval is what we are working on right now,” Bold said.
The company is hoping to expand the range of possible applications of the CellMist System. Not only is the SkinGun an effective treatment for burns and other skin disorders, according to Bold, the scarring is also minimal compared with grafting.
Burn victims may seek the help of a dermatologist after they’ve healed, since they often have debilitating scars, noted Dr. Cameron Rokhsar, an associate professor of dermatology at Mount Sinai Hospital and fellow of the American Society for Dermatologic Surgery.
Recently, another innovative product has transformed this often-necessary aftercare for burn patients.
Help after healing
Not only are patients bothered psychologically, sometimes, their “scars are painful, they’re itchy, they’re thick, and they cause loss of function,” said Rokhsar, who is not affiliated with RenovaCare. Function loss is a result of “contracture,” in which the scar tissue constricts and lessens mobility. After they heal, some burn victims cannot use their limbs.
“One of the breakthroughs in the past couple of years is the use of fractionated CO2 lasers to release the tension on those type of scars, where people can actually get function back,” Rokhsar said. He explained that these lasers have been in use for various purposes about 10 years.
“The laser evaporates tiny microscopic zones of tissue, almost like it drills tiny holes in the skin in a microscopic fashion, and that allows the scar to remodel itself,” Rokhsar said. He added that the efficacy has been established in studies involving veterans who were burned in explosions. Today, many dermatologists use these lasers on burn victims “post facto”: once they’ve healed.
“We’ve been using it. It’s pretty amazing,” Rokhsar said, adding tha