Компания из Лас-Вегаса вырастает кожу в лаборатории для лечения ожогов

Las Vegas company grows patients’ skin in lab to treat severe burns Severe burns cause one of the most excruciating forms of pain a person can endure and the subsequent treatment has often proved more painful than the initial trauma. For all the advances in modern medicine, severe burn care has long been limited to grueling skin grafting in which the most effective option transplants healthy skin from a part of a patient’s body to cover a wound. Regenicin, a biotechnology company in Las Vegas with a lab at Roseman (University) Bioventures, is working on a better solution. Simply put, instead of taking a lot of healthy skin from a severely burned patient, it takes a small postage-stamp size piece of skin and grows it in the lab into a piece up to 100 times larger in about 28 days before putting it on the patient’s wound. “I was completely shocked when I learned about Regenicin and got the opportunity to work at this lab,” said Josh Axtell, a grad student and lab assistant at Roseman who is writing his thesis on the company. “I knew skin grafts were possible, but I didn’t know autologous skin cell culture was a thing (where a patient’s own skin cells are grown and multiplied in a lab). “I didn’t realize that there are companies that take skin cells from patients and they grow them and then they put them on those same patients because it reduces the chance of rejection. It’s an amazing process and it’s really interesting to see how everything works.” Regenicin is now preparing a new FDA-regulated clinical program for its product — an autologous cultured skin substitute that will be called Tiscela (formerly known as NovaDerm) — that will treat catastrophic burns. “If you have a significant enough part of your body that’s been burnt, there’s really very little that they can do to help you,” said Dr. K.E. Castro, director of clinical trials for Regenicin. “The first thing doctors do is they remove all the damaged skin, which leaves your frayed nerves open. They patch it temporarily, but most unnatural patches, or things that aren’t part of your body, are going to be rejected because of your immune system. “The best method currently for treating this is to take patches of skin from other parts of the person’s body, stretch them out and then apply those to the damaged area. But the patient has already lost a lot of skin and now you’re taking their healthy skin and you’re moving it over. … So it’s painful on both sides, and it’s very difficult to get enough skin to patch up 50 percent of your body.” Regenicin’s FDA Investigational New Drug (IND) application will be for patients with burns over at least 20 percent of their body. “But we’re expecting that most of our burn victims will be one-third of their bodies or 50 percent,” Castro said. “When it gets to be 20 percent or more is when you really start to need this. Your nerves are frayed and it’s permanent.” Castro said the process begins by taking a 35-millimeter patch of skin from the patient, usually from the inner thigh. In the lab, they then grow millions of skin cells into billions. “We then take those cells, put them on a collagen scaffold that we developed … and they grow together, much like your natural skin would do when it was healing a part of your body,” she said. “Then those patches become our cultured skin substitute. We’re literally creating the transplant. “Ultimately we may be able to do more, but the goal right now is to be able to provide a replacement for the current treatment, allowing the patient to heal and basically feel far less pain in the process.” Fully funded Regenicin, which was founded in 2010, originally intended to finalize an IND application in 2016. “Going back and forth 15 or 20 years to develop a product that is going to be used on humans is not abnormal. In fact, it’s the typical time frame,” Castro said. “It takes a lot to get to clinical trials and approved. You need a lot of money and a lot of expertise to get there. “The company’s gone through a lot of shifts and changes and funding issues. Until 2022, we didn’t have the funding to completely get through the clinical trial. But our strongest point right now is we’re fully funded. We have enough to finish our initial clinical trial.” Castro, who has lived in Las Vegas since 1996 and earned one of her five college degrees at UNLV, said the company received almost $50 million in presale funding in 2022 and 2023. Part of that funding covered the cost of the lab at Roseman, where Regenicin’s headquarters have been since 2024. “Regenicin’s approach brings donor-specific skin cell regeneration closer to reality, addressing a significant unmet need for patients with burns and other complex wounds,” Roseman Bioventures managing director Titus Plattel said. “Roseman Bioventures is excited to support the advancement of this promising technology and help bring innovative healthcare solutions to patients in Nevada and beyond.” Orphan-Drug Designation Castro said the path toward FDA approval might be helped by the fact that the FDA previously gave the product an Orphan-Drug Designation — a special status granted to medicines intended to prevent, diagnose or treat rare diseases or conditions. “It’s a designation for solutions to medical issues that have no good solution. In this case, they recognize that the current solution is not a good one,” Castro said. “As a result, we’ve been told before by the FDA that we can do a very small clinical trial and get approval upon success.” In April, Regenicin partnered with Made Scientific, a cell therapy contract development and manufacturing organization in Princeton, New Jersey, to advance Tiscela toward a U.S. FDA orphan product approval. Castro said the next steps for the company are to file the IND application and then conduct its first in-human clinical trials. “We’re really close,” she said. “Hopefully we get clearance to start a clinical trial next year and have our contracts with our burn centers during that time. If our orphan-drug application is successful, we may get approval by the end of next year. So 2027 would be the best of timelines. That is our goal right now. “I’m pretty confident, actually. I’ve watched the skin grow. I’ve looked at the cultured skin substitute.” Contact reporter Todd Dewey at [email protected]. Follow @tdewey33 on X.