RenovaCare is developing breakthrough technologies to address America’s $45 billion wound and burn treatment market. Our flagship CellMist™ System makes use of a patient’s own stem cells, which are sprayed onto wounds using our novel SkinGun™ device.
For patients suffering severe burns and other wounds, the prospect of a quick-healing, gentle spray containing their own stem cells will be a promising alternative to conventional skin graft surgery, which can be painful, prone to complications, and slow-to-heal. Based on preliminary case studies, CellMist™ System patients can be treated within 90 minutes of arriving in an emergency room; a patient’s stem cells are isolated, processed, and sprayed on to wound sites for rapid healing.
Preliminary investigational use in Europe and the United States indicate the potential efficacy and safety of RenovaCare’s technologies. Clinical observations point to the potential for regeneration of new skin in as little as four days, rather than the many weeks of painful and risky recovery required by traditional skin graft techniques. These technologies are the result of nearly a decade of ongoing research and development dedicated to finding the most effective way to access the regenerative properties of a patient’s own skin stem cells, and the most efficient way to deliver these potent cells to heal moderate to severe skin wounds. We believe that RenovaCare’s CellMist™ System and SkinGun™ spray device are the world’s most advanced technologies of their kind.
This device system requires further clinical evaluation and data collection prior to submission of a premarketing application to the US FDA. At this time it is an investigational system and is not available for general use or sales in the United States.
The CellMist™ System RenovaCare’s CellMist™ System is comprised of two components:
- CellMist™ Solution A liquid suspension of the patient’s own stem cells
- SkinGun™ An ultra-gentle spray device which delicately deposits the CellMist™ Solution on to a patient’s wounds
Wikipedia indicates that so far the skin gun treatment has been used exclusively with second degree burns, though there is strong evidence that the treatment will be successful in treating a variety of skin wounds and skin disorders. Patients with infected wounds or with delay in wound healing are suitable for cell grafting treatment. Third-degree burns, however, completely deprive victims of both their epidermis and dermis skin levels, which exposes the tissue surrounding the muscles. The skin gun has not progressed to the point where it can be used for such advanced wounds, and these patients must seek more traditional treatment methods. The skin gun is generally not used for burn victims with anything less than a second-degree burn either. First degree-burns still maintain portions of the epidermis and can readily heal on their own, thus they do not need this expensive technology.
Currently, the skin gun’s applications have not been extended to include the regeneration of skin lost due to other injuries or skin diseases. It is also limited in that it is only effective immediately following the burn incident.
The average healing time for patients with second degree burns is three to four weeks. This is reduced to a matter of days with skin gun treatment
Traditional skin grafting can be risky, in that chances for infection are relatively high. The skin gun alleviates this concern because the increased speed in which the wound heals directly correlates to the decreased time the wound can be vulnerable to infection. Because of the rapid re-epithelialization associated with skin gun treatment, harmful side effects that can result from an open wound are significantly reduced. Applying the skin cells is quick and doesn’t harm the patient because only a thin layer of the patients’ healthy skin is extracted from the body into the aqueous spray. The electronic spray distributes the skin cells uniformly without damaging the skin cells, and patients feel as if they are sprayed with salt water.
Because the skin cells are actually the patient’s own cells, the skin that is regenerated looks more natural than skin grown from traditional methods. During recovery, the skin cells grow into fully functional layers of the skin, including the dermis, epidermis, and blood vessels. The regenerated skin leaves little scarring. The basic idea of optimizing regenerative healing techniques to damaged biological structures demonstrated by the skin gun in the future may also be applied to engineering reconstruction of vital organs, such as the heart and kidneys.
There are major limitations: the method will not work on deep burns that go through bone and muscle, specifically below the dermis. As of 2011, only several dozen patients have been treated; it remains an experimental, not a proven, method. As of 2011, the skin gun was still in its prototyping stage, since it has only treated a dozen patients in Germany and the US, compared to over 50,000 treated with Dermagraft bioengineered skin substitute. There is thus a lack of published peer reviewed clinical evidence, and no knowledge of long-term stability of the newly generated skin
Skingun Procedure – Initially stamp-sized healthy skin of the injured patient is taken and stem cells were collected from it. Then they are harvested by using suitable enzymes. The prepared cell suspension is injected into sterile syringe and inserted into the gun. This gun helps in uniform spreading of the cells on wound. These cells will migrate, multiple, and differentiate forming a new tissue. The complete process occurs with in 2 hr. Full regeneration of skin occurs in 2 weeks and complete formation of texture tools 2-3 months
The CellMist™ Solution is a liquid suspension containing a patient’s own regenerative skin stem cells. A small sample (as little as a square inch) of the patient’s skin is quickly processed to liberate the stem cells from surrounding tissue. The resulting product is referred to as the ‘CellMist™ Solution’. The CellMist™ Solution is placed in the SkinGun™ for spray application onto the patient’s wound.
The CellMist™ Solution, containing the patient’s stem cells, is transferred to the SkinGun™. The SkinGun™ sprays the cells onto wound sites to begin healing. Unlike conventional aerosol and pump systems, our next-generation fluid sprayer does not expose fragile cells to strong forces that can tear them apart. Instead our SkinGun™ gently delivers the CellMist™ Solution directly to the wound site using a positive-pressure air stream.
SOURCES – RenovaCare, Wikipedia, International Journal of Pharmacometrics and Integrated Biosciences (IJPIB)