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The skin cell gun, also known as the skin gun or SkinGun, is a medical device that sprays a patient's own autologous (self-donated) stem cells to treat burns and other wounds. The SkinGun is used to deliver adult stem cells, derived from a small specimen of the patient's own skin using a proprietary enzymatic process, to the wound site. The cells then differentiate and grow into normal skin, healing the wound. This treatment can replace conventional methods, such as skin grafting, for treating severe wounds. This method can achieve donor-to-wound expansion ratios of 1:100 or higher,[1] compared to typical expansion ratios of 1:2 to 1:4 for skin grafts. Studies demonstrate that damaged skin tissue regenerates after SkinGun treatment significantly more quickly than after traditional treatment methods. [2] [3] [4] [5]

The SkinGun, along with related cell isolation methodologies, were acquired by RenovaCare, Inc. in 2013.[6] The company has since bolstered its intellectual property holdings related to these technologies, with US patents in 2016[7] and 2017[8]. RenovaCare continues to develop its technologies and therapeutic protocols for commercial distribution, under the brand names SkinGun and CellMist System.[9] In addition to treating burns, the company is exploring opportunities to expand SkinGun therapies to other indications, including chronic wounds, pigmentation disorders, scar remediation, and cosmetic applications. [10]

Operation

Cells from a small sample of the patient's undamaged skin are isolated using a proprietary enzymatic tissue processing protocol. The resulting cell suspension is transferred to a sterile syringe, which is then inserted into the SkinGun. Using its unique spray mechanism, the device distributes cells directly and uniformly into the wound. The newly introduced stem cells begin to migrate, multiply, and differentiate, creating new skin tissue in a matter of days.

The entire process – from collecting the skin sample, processing it into a cell suspension, and using the SkinGun to spray the stem cells – takes approximately 1.5–2 hours from start to finish. Full re-epithelialization can occur in as little as four days[4], and after a few months the skin will regain its color and texture.[11][12]

History

The first experimental versions of the device were developed by Dr. Jörg Gerlach and StemCell Systems GmbH in Berlin, Germany. Dr. Gerlach and SCS had already developed cell culture bioreactors for culturing usable liver and other solid organ tissues from stem cells, and were seeking a similar platform to culture living skin. They soon discovered that, compared to other organs, the skin is a special case. A skin wound is itself an accessible environment that provides excellent conditions to culture new skin tissue in vivo. This solves the problems of wait times and special challenges in transplanting delicate, cultured tissue inherent to in vitro skin culture technologies.[13]

Researchers developed stem cell isolation techniques that maximize stem cell availability for transplantation.[14] To ensure minimal loss in transplanting the isolated cells, engineers at StemCell Systems designed a deposition device, the SkinGun, to gently deliver the cell suspension without exposing cells to harsh forces in conventional spray devices.[14]

The SkinGun method was first used experimentally at Charité University Hospital on a group of nineteen patients[when?]. The clinician in that study determined that the results from the SkinGun treatment was so significantly better than traditional grafting that he discontinued performing skin grafts on a control group on the basis of medical ethics.[2]

Subsequently several SkinGun procedures have been performed at UPMC Mercy Hospital in Pittsburgh, including patients who have been able to leave hospital within four days of treatment.[4]

Biological basis of wound healing

Main article: Wound healing

After an abrasion, cut, burn, or other injury, the body initiates several different biological processes to repair the skin.[15] Wound healing generally has three different stages: the inflammatory stage, the proliferative stage and the remodeling stage.[16]

Once the skin is damaged, a series of interrelated events take place in close succession in order to repair the skin.[17] Within minutes after an injury occurs, blood platelets collect at the site of injury to form a clot. This clot limits bleeding at the injury site.

The inflammatory phase involves increased white blood cell activity, removing bacteria and debris from the wound. Biochemical signals instruct regenerative cells to begin dividing, to create new skin tissues much more rapidly than normal.

The proliferative phase is marked by the formation of new skin tissue at the injury site and the general shrinking and eventual disappearance of the wound.[18] New blood vessels are also established during the healing process. The wound is made smaller by myofibroblasts, which hold on to the edges of the wound and slowly get smaller by a system similar to the contraction of muscle cells.

During the remodeling phase, the skin acquires its permanent texture and cells that are no longer needed for healing are disposed of through apoptosis.

Applications

To date SkinGun treatment has been used exclusively with second degree burns, though there is strong evidence that the therapy 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.[4] Third-degree burns, however, completely deprive victims of both their epidermis and dermis skin levels, which exposes the tissue surrounding the muscles. The SkinGun 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 SkinGun 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 SkinGun'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.[19]

Benefits and side effects

The average healing time for patients with second degree burns is three to four weeks.[20] This is reduced to a matter of days with SkinGun treatment.[2][3][4]

Traditional skin grafting can be risky, in that chances for infection are relatively high. The SkinGun 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 SkinGun treatment, harmful side effects that can result from an open wound are significantly reduced.[21] 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.[21]

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.[22] The regenerated skin leaves little scarring. The basic idea of optimizing regenerative healing techniques to damaged biological structures demonstrated by the SkinGun in the future may also be applied to engineering reconstruction of vital organs, such as the heart and kidneys.[22]

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 SkinGun 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.

In the media

The SkinGun has been featured in numerous books and television shows, including the following examples.

  • Popular Science magazine's July 2008 issue discusses the SkinGun in an article about new medical technologies in a military context.[23]
  • National Geographic Explorer produced a segment on the SkinGun's use in burn treatments, and featured a patient who was released from hospital four days after treatment.[24] This segment first aired on February 7, 2011.
  • Marvel Comics' Avengers Academy issue #14 (July 2011) features the skin cell gun and Dr. Gerlach in conjunction with a storyline where two of the characters are treated for burns injuries from an explosion.[25]
  • Robin L. Smith, MD discusses the SkinGun along with other stem cell therapies in the 2013 book, "The Healing Cell: How the Greatest Revolution in Medical History is Changing Your Life".[26]
  • Tony Robbins discusses SkinGun technology in his 2014 book, "Money, Master the Game: 7 Steps to Financial Freedom".[27]
  • The SkinGun is featured in DHO Health Science, 8th edition, a 2014 textbook by Louise Simmers, RN.[28]
  • Mashable featured a video of the SkinGun on their Facebook page in November 2016, garnering nearly a million shares.[29]

References

  1. ^ Esteban-Vives, Roger; Young, Matthew T.; Zhu, Toby; Beiriger, Justin; Pekor, Chris; Ziembicki, Jenny; Corcos, Alain; Rubin, Peter; Gerlach, Jörg C. (2016-12-01). "Calculations for reproducible autologous skin cell-spray grafting". Burns. 42 (8): 1756–1765. doi:10.1016/j.burns.2016.06.013.
  2. ^ a b c Hartmann B., et al. Sprayed cultured epithelial autografts for deep dermal burns of the face and neck. Ann Plast Surg. 2007 Jan;58(1):70-3. (link retrieved Feb 4, 2015)
  3. ^ a b Gerlach, J. C. et al. Method for autologous single skin cell isolation for regenerative cell spray transplantation with non-cultured cells. Int J Artif Organs 2011; 34(3): 271 - 279 (link retrieved Feb 4, 2015)
  4. ^ a b c d e Gerlach, J. C. et al. Autologous skin cell spray-transplantation for a deep dermal burn patient in an ambulant treatment room setting. Burns 37, e19-e23 (2011) (link retrieved Feb 4, 2015)
  5. ^ Esteban-Vives, Roger; Choi, Myung S.; Young, Matthew T.; Over, Patrick; Ziembicki, Jenny; Corcos, Alain; Gerlach, Jörg C. (2016-11-01). "Second-degree burns with six etiologies treated with autologous noncultured cell-spray grafting". Burns. 42 (7): e99–e106. doi:10.1016/j.burns.2016.02.020.
  6. ^ RenovaCare, Inc. (formerly Janus Resources, Inc.) SEC form 8-K/A filed on November 21, 2013.. (link retrieved Feb 4, 2015)
  7. ^ Device for cell spraying, manufacturing of the device, method for spraying with the device and a cell suspension sprayed with the device, 29 Nov 2016, retrieved 2017-10-12 {{citation}}: Unknown parameter |inventor-first= ignored (help); Unknown parameter |inventor-last= ignored (help)
  8. ^ "Cell spraying device, method and sprayed cell suspension". Reinhard Bornemann, RENOVACARE SCIENCES CORP., RENOVACARE SCIENCES CORP. 2013-12-20. {{cite journal}}: Cite journal requires |journal= (help)CS1 maint: others (link)
  9. ^ "Our Technology | RenovaCare". RenovaCare. Retrieved 2017-10-13.
  10. ^ RenovaCare, Inc. Website Technology Q&A (link retrieved Feb 4, 2015)
  11. ^ Ellis, Bob (3 Feb 2011). "Skin Gun Uses Adult Stem Cells". Dakota Voice. Retrieved 20 April 2011.
  12. ^ Lorianna De Giorgio, "Skin gun that sprays stem cells being used on burn victims", Toronto Star, February 7, 2011
  13. ^ RenovaCareInc.com 'About' page(link retrieved Feb 10, 2015)
  14. ^ a b Gerlach, JC; Johnen, C; Ottomann, C; Bräutigam, K; Plettig, J; Belfekroun, C; Münch, S; Hartmann, B. "Method for autologous single skin cell isolation for regenerative cell spray transplantation with non-cultured cells". Int J Artif Organs. 34: 271–9. PMID 21480179.
  15. ^ Nguyen, D.T., Orgill D.P., Murphy G.F. (2009).The Pathophysiologic Basis for Wound Healing and Cutaneous Regeneration. New York pg. 234 .
  16. ^ Quinn, J.V. . Tissue Adhesives in Wound Care. B.C. Decker. Hamilton Decker Inc., Ont. B.C. ,1998
  17. ^ Stadelmann, WK; Digenis, AG; Tobin, GR . "Physiology and healing dynamics of chronic cutaneous wounds.". American journal of surgery 1998. pg 176
  18. ^ N/A Biomaterials For Treating Skin Loss. Woodhead Publishing (UK/Europe) & CRC Press (US), Cambridge/Boca Raton, pg 25-57.
  19. ^ "Skin gun sprays stem cells for fast recovery from serious burns." RobAid, February 6, 2011. Accessed March 26, 2011. [1]
  20. ^ Scott & White Healthcare, “Second-Degree Burn” “Second-Degree Burn”
  21. ^ a b Hanlon, Tegan. "Skin-cell Gun Expedites Burn Victim Recovery Time." The Pitt News (Pittsburgh), February 2, 2011. Accessed March 29, 2011. [2]
  22. ^ a b Underwood, Anne. "Military Medicine: The War on Wounds - Newsweek." Newsweek. 10 May 2008. Web. 10 May 2011. [3].
  23. ^ "Rebuilding the Troops", Popular Science, July 2008, p. 29.
  24. ^ Skin Gun segment video, nationalgeographic.com.
  25. ^ Avengers Academy, Marvel Comics, Issue 14, July 2011 (story synopsis)
  26. ^ Smith, R., et al., The Healing Cell: How the Greatest Revolution in Medical History is Changing Your Life, Center Street Publishing, 2013.
  27. ^ Robbins, Tony, Money, Master the Game: 7 Steps to Financial Freedom, Simon & Schuster, New York, 2014, pp. 551-2.
  28. ^ Simmers, L, et al., DHO Health Sciences, 8th ed., Cenage Learning, Stamford, CT, 2014, p 518.
  29. ^ "Mashable". www.facebook.com. Retrieved 2017-10-17.
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