When Thomas Bold joined RenovaCare in 2013, he was already familiar with its potentially groundbreaking technology. Bold had served as StemCell Systems CEO in Berlin for many years. He was involved in the development of the CellMist and SkinGun – the platform technologies for RenovaCare Inc.
The technologies represent a shift in thinking about wound care, Bold said. Bold’s goal is to steer publically-traded RenovaCare to “market the world’s most advanced technology for skin repair using a patient’s own stem cells.” The company recently released the results of a case study featuring a burn victim who showed exceptional results. He answered some Medical Design & Outsourcing questions about the nature of RenovaCare’s technology and how he sees it developing in the future.
MDO: Can you describe RenovaCare’s platform technology?
Bold: For patients and surgeons, our development of spray-on stem cells for rapid and scar-free healing of severe second-degree burns is life-changing.
The CellMist system has two components: the CellMist solution, a water-based solution with the patient’s own stem cells, and the SkinGun, an ultra-gentle spray device which deposits the CellMist solution
A small sample of the patient’s healthy skin is processed to liberate the stem cells from surrounding tissue. The cells are suspended in a water-based solution, placed into a syringe, the syringe is attached to the SkinGun. For the spraying process, we use air flow to gently float the cells onto the wound.
With this technology, we are achieving incredible cell survival rates because the cells are never exposed to thrashing or turbulent forces. Cell survival and, consequently, the number of vital cells determine the ability to heal the wound. In-vitro studies have shown that our SkinGun achieves 97% cell survival.
A wound heals from the edges to the middle and the longer that takes the higher is the risk for inflammation and finally scarring.
With our technology, the stem cells act as thousands of little regenerative islands all over the wound where they will connect to each other and finally close the wound with an epithelial layer. Once this layer is closed, the wound is dry and considered to be healed. After this process, the cosmetic healing will happen all naturally and the result should be a skin that looks, feels and functions as it did before.
MDO: How does the treatment application work?
Bold: The entire process, as explained above, takes about 90 minutes from taking the healthy skin sample to spraying the cells onto the wound.
By spraying the patient’s stem cells, the RenovaCare SkinGun overcomes the need for removing large sheets of donor skin and the resultant healing has not required prolonged physical therapy. The spray procedure is gentle, and the skin that regrows looks, feels and functions as the original skin that it replaces.
MDO: What technology challenges have you faced?
Bold: The challenge you have here is how to bring the cells into the wound without killing them. Cell viability and the number of viable cells are essential for the rapid healing process as described before.
With our SkinGun we have designed a device, which meets the “gold-standard” regarding cell viability. Test results from the Charité, Berlin, one of the world’s largest university hospitals, show that human skin stem cells sprayed with the company’s patented SkinGun maintained 97.3% viability.
We have seen that with conventional nozzle technology a lot of cells get killed. Therefore we are avoiding this technology and use an air stream at the end of the syringe needle. Our method creates a cell mist and this way the cells are ultra-gently distributed throughout the entire wound.
Our technology is patented in Germany. At the end of 2016, we were granted an additional United States patent for the SkinGun device.
MDO: How does Skin Gun differ from other treatments on the market?
Bold: Skin grafting has been the traditional treatment for burns and wounds for centuries.
More recently, mesh grafting has become the latest standard of care. This process surgically removes large sheets of healthy skin from the patient. Following this painful donor procedure, the sheet is punctured in a grid-like pattern to form an expandable mesh. Surgeons pull this mesh as wide as feasible and surgically stitch this skin to the patient’s wound. The procedure is extremely painful, creates an additional wound at each donor site, and results very often in poor cosmetic outcomes, often with scarred and deformed skin.
This transplanted skin can result in really bad consequences, restricting joint movement and it is unable to grow with the patient. Consequently, mesh graft patients require months and years of physical therapy and can face also psychological problems from the permanent disfigurement of scarring. In addition, long-term pain management with painkillers is very often necessary.
Mesh grafting is the standard of care today and very important to note here is, that a sheet of meshed skin covers only up to six times its original donor area. The RenovaCare system covers up to 100 times its donor skin sample. This is why the donor skin sample can be so small compared to the injured treatment area.
MDO: What are your next steps?
Bold: The SkinGun technology is currently under development and not approved for clinical use in the United States. In recent years, physicians in Berlin and Pittsburgh, PA have treated dozens of burn patients using our technology under innovative practice and experimental studies with very positive results.
In order to achieve FDA clearance for the CellMist System and the SkinGun, it will be our upcoming steps to prove safety and efficacy within the applicable clinical trial formats and according to the relevant regulatory requirements.
We need to set up the applicable clinical trial formats according to the relevant regulatory requirements. But as a publically traded company, I cannot speculate on a timeline here.
MDO: Do you see your technology as a platform for meeting more medical needs?
Bold: The prospect of spraying a patient’s own stem cells onto burns and wounds to create fast and scar free healing is a promising alternative to today’s painful and disfiguring skin grafting procedures. We are working towards natural, rapid healing, where the patient’s new skin can look and function as well as it once did.
Currently, we are focusing on severe second-degree burns. Besides burns and wounds, we see the RenovaCare technology also applicable for other indications, such as cosmetic procedures targeting skin pigmentation disorders, scar treatment, and other related conditions.
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