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RenovaCare, Inc.
	File:RenovaCare Logo.png
Company type	Public
Industry	Regenerative medicine, Medical devices
Founded	January 7, 2014; 10 years ago in New York, NY, USA
Headquarters	Pittsburgh, United States
Products	SkinGun and CellMist System
Website	www.renovacareinc.com

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RenovaCare, Inc. is a regenerative medicine company based in Pittsburgh, headed by CEO Thomas Bold. The company is the developer of the SkinGun and CellMist System for autologous stem cell spray grafting to treat burns and other skin injuries. The company is publicly listed (OTCQB:RCAR).

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+{{Infobox company
-The '''skin cell gun''', also known as the '''skin gun''' or '''SkinGun''', is a [[medical device]] that sprays a [[patient]]'s own [[Autologous stem cell transplantation|autologous]] (self-donated) [[stem cell]]s to treat [[burn]]s and other [[wound]]s.  The SkinGun is used to deliver [[adult stem cell]]s, derived from a small specimen of the patient's own [[Human skin|skin]] using a proprietary [[Enzyme|enzymatic]] process, to the wound site.  The cells then [[Cellular differentiation|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,<ref>{{Cite journal|last=Esteban-Vives|first=Roger|last2=Young|first2=Matthew T.|last3=Zhu|first3=Toby|last4=Beiriger|first4=Justin|last5=Pekor|first5=Chris|last6=Ziembicki|first6=Jenny|last7=Corcos|first7=Alain|last8=Rubin|first8=Peter|last9=Gerlach|first9=Jörg C.|date=2016-12-01|title=Calculations for reproducible autologous skin cell-spray grafting|url=http://www.sciencedirect.com/science/article/pii/S0305417916301851|journal=Burns|volume=42|issue=8|pages=1756–1765|doi=10.1016/j.burns.2016.06.013}}</ref> compared to typical expansion ratios of 1:2 to 1:4 for skin grafts.  Studies demonstrate that damaged skin tissue [[regeneration (biology)|regenerates]] after SkinGun treatment significantly more quickly than after traditional treatment methods.
+| name = RenovaCare, Inc.
-<ref name="Plast Surg 58">Hartmann B., et al. [https://www.ncbi.nlm.nih.gov/pubmed/17197946 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)</ref>
+| logo = RenovaCare Logo.png
-<ref name="Artif Organs 34">Gerlach, J. C. et al. [https://www.ncbi.nlm.nih.gov/pubmed/21480179 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)</ref>
+| type = [[Public Company|Public]]
-<ref name="Burns 37">Gerlach, J. C. et al. [https://www.ncbi.nlm.nih.gov/pubmed/21334816 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)</ref>
+| industry = [[Regenerative medicine]], [[Medical device]]s
-<ref>{{Cite journal|last=Esteban-Vives|first=Roger|last2=Choi|first2=Myung S.|last3=Young|first3=Matthew T.|last4=Over|first4=Patrick|last5=Ziembicki|first5=Jenny|last6=Corcos|first6=Alain|last7=Gerlach|first7=Jörg C.|date=2016-11-01|title=Second-degree burns with six etiologies treated with autologous noncultured cell-spray grafting|url=http://www.sciencedirect.com/science/article/pii/S0305417916000802|journal=Burns|volume=42|issue=7|pages=e99–e106|doi=10.1016/j.burns.2016.02.020}}</ref>
+| fate =
+| predecessor = <!-- or: | predecessors = -->
+| successor = <!-- or: | successors = -->
+| founded = {{Start date and age|2014|01|07}} in [[New York]], [[NY]], [[USA]]
+| founder = <!-- or: | founders = -->
+| defunct = <!-- {{End date|YYYY|MM|DD}} -->
+| hq_location_city = [[Pittsburgh]]
+| hq_location_country = [[United States]]
+| area_served = <!-- or: | areas_served = -->
+| key_people =
+| products = [[SkinGun]] and CellMist System
+| owner = <!-- or: | owners = -->
+| num_employees =
+| num_employees_year = <!-- Year of num_employees data (if known) -->
+| parent =
+| website = {{URL|www.renovacareinc.com}}
+}}RenovaCare, Inc. is a regenerative medicine company based in Pittsburgh, headed by CEO Thomas Bold.  The company is the developer of the [[SkinGun]] and CellMist System for [[autologous]] [[stem cell]] spray grafting to treat burns and other skin injuries.  The company is publicly listed (OTCQB:RCAR).
+{{Company-stub}}{{Stub medicine}}
-The SkinGun, along with related cell isolation methodologies, were acquired by RenovaCare, Inc. in 2013.<ref name="Edgar 23011121">[https://www.sec.gov/Archives/edgar/data/1016708/000147793213005819/jani_ex101.htm RenovaCare, Inc. (formerly Janus Resources, Inc.) SEC form 8-K/A filed on November 21, 2013.].  (link retrieved Feb 4, 2015)</ref>  The company has since bolstered its intellectual property holdings related to these technologies, with US [[Patent|patents]] in 2016<ref>{{Citation|title=Device for cell spraying, manufacturing of the device, method for spraying with the device and a cell suspension sprayed with the device|date=29 Nov 2016|url=http://www.google.ch/patents/US9505000|inventor-last=Bornemann|inventor-first=Reinhard|issue=US9505000 B2|accessdate=2017-10-12}}</ref> and 2017<ref>{{Cite journal|date=2013-12-20|others=Reinhard Bornemann, RENOVACARE SCIENCES CORP., RENOVACARE SCIENCES CORP|title=Cell spraying device, method and sprayed cell suspension|url=https://patents.google.com/patent/US9610430B2/en}}</ref>. RenovaCare continues to develop its technologies and therapeutic protocols for commercial distribution, under the brand names SkinGun and CellMist System.<ref>{{Cite news|url=https://renovacareinc.com/technology/|title=Our Technology {{!}} RenovaCare|work=RenovaCare|access-date=2017-10-13|language=en-US}}</ref>  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.
-<ref name="RCAR FAQ">[http://renovacareinc.com/investors/faqs/ RenovaCare, Inc. Website Technology Q&A] (link retrieved Feb 4, 2015)</ref>
-==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<ref name="Burns 37" />, and after a few months the skin will regain its color and texture.<ref name="Ellis, Bob">{{cite news |title= Skin Gun Uses Adult Stem Cells|author= Ellis, Bob |url= http://www.dakotavoice.com/2011/02/skin-gun-uses-adult-stem-cells |newspaper= Dakota Voice |date= 3 Feb 2011|accessdate=20 April 2011}}</ref><ref>Lorianna De Giorgio, [https://www.thestar.com/news/world/article/934581--skin-gun-that-sprays-stem-cells-being-used-on-burn-victims "Skin gun that sprays stem cells being used on burn victims"], ''Toronto Star'', February 7, 2011</ref>
-==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.<ref name="RCARabout">[http://renovacareinc.com/corporate/about/ RenovaCareInc.com 'About' page](link retrieved Feb 10, 2015)<!-- need better reference here --></ref>
-Researchers developed stem cell isolation techniques that maximize stem cell availability for transplantation.<ref name="Johnen">{{cite journal | pmid = 21480179 | volume=34 | title=Method for autologous single skin cell isolation for regenerative cell spray transplantation with non-cultured cells | journal=Int J Artif Organs | pages=271-9 | last1 = Gerlach | first1 = JC | last2 = Johnen | first2 = C | last3 = Ottomann | first3 = C | last4 = Bräutigam | first4 = K | last5 = Plettig | first5 = J | last6 = Belfekroun | first6 = C | last7 = Münch | first7 = S | last8 = Hartmann | first8 = B}}</ref> 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.<ref name="Johnen"/>
-The SkinGun method was first used experimentally at [[Charité|Charité University Hospital]]  on a group of nineteen patients{{when|date=December 2016}}. 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.<ref name="Plast Surg 58"/>
-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.<ref name="Burns 37"/>
-==Biological basis of wound healing==
-{{Main|Wound healing}}
-After an abrasion, cut, burn, or other injury, the body initiates several different biological processes to repair the skin.<ref>Nguyen, D.T., Orgill D.P., Murphy G.F. (2009).The Pathophysiologic Basis for Wound Healing and Cutaneous Regeneration. New York pg. 234 .</ref> Wound healing generally has three different stages: the [[Inflammation|inflammatory]] stage, the [[Cell growth|proliferative]] stage and the [[Wound healing#Maturation and remodeling|remodeling]] stage.<ref>Quinn, J.V. . Tissue Adhesives in Wound Care. B.C. Decker. Hamilton Decker Inc., Ont. B.C. ,1998</ref>
-Once the skin is damaged, a series of interrelated events take place in close succession in order to repair the skin.<ref>Stadelmann, WK; Digenis, AG; Tobin, GR . "Physiology and healing dynamics of chronic cutaneous wounds.". American journal of surgery 1998. pg 176</ref> Within minutes after an injury occurs, blood [[platelet]]s 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.<ref>N/A Biomaterials For Treating Skin Loss. Woodhead Publishing (UK/Europe) & CRC Press (US), Cambridge/Boca Raton, pg 25-57.</ref> 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.<ref name="Burns 37"/>  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.<ref>"Skin gun sprays stem cells for fast recovery from serious burns." RobAid, February 6, 2011. Accessed March 26, 2011. [http://www.robaid.com/bionics/skin-cell-gun-sprays-stem-cells-for-fast-recovery-from-serious-burns.htm]</ref>
-==Benefits and side effects==
-The average healing time for patients with second degree burns is three to four weeks.<ref name="2DegHeal">Scott & White Healthcare, “Second-Degree Burn”  [http://www.sw.org/HealthLibrary?page=Second-Degree%20Burn “Second-Degree Burn”]</ref>  This is reduced to a matter of days with SkinGun treatment.<ref name="Plast Surg 58"/><ref name="Artif Organs 34"/><ref name="Burns 37"/>
-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.<ref name="pittnews.com">Hanlon, Tegan. "Skin-cell Gun Expedites Burn Victim Recovery Time." The Pitt News (Pittsburgh), February 2, 2011. Accessed March 29, 2011. [http://pittnews.com/newsstory/skin-cell-gun-expedites-burn-victim-recovery-time]</ref>
-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.<ref name="pittnews.com"/>
-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.<ref name="newsweek.com">Underwood, Anne. "Military Medicine: The War on Wounds - Newsweek." Newsweek. 10 May 2008. Web. 10 May 2011. [http://www.newsweek.com/2008/05/10/war-on-wounds.html].</ref> 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.<ref name="newsweek.com"/>
-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.<ref name="PopSci">"Rebuilding the Troops", [https://books.google.com/books?id=9jsEAAAAMBAJ&lpg=PA29&dq=%22skin%20gun%22&pg=PA29#v=onepage&q=%22skin%20gun%22&f=false Popular Science], July 2008, p. 29.</ref>
-* [[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.<ref name="NatGeo">[http://channel.nationalgeographic.com/explorer/videos/the-skin-gun/ Skin Gun segment video, nationalgeographic.com.]</ref>  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.<ref name="AA14">Avengers Academy, Marvel Comics, Issue 14, July 2011 ([http://uncannyxmen.net/comics/issue/avengers-academy-14 story synopsis])</ref>
-* 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".<ref name="RSmith">Smith, R., et al., [https://books.google.com/books?id=SMpsy3ZVzzkC&lpg=PT44&dq=%22skin%20gun%22&pg=PT44#v=onepage&q=%22skin%20gun%22&f=false The Healing Cell: How the Greatest Revolution in Medical History is Changing Your Life], Center Street Publishing, 2013.</ref>
-*[[Tony Robbins]] discusses SkinGun technology in his 2014 book, "Money, Master the Game: 7 Steps to Financial Freedom".<ref name="TRobbins">Robbins, Tony, [http://books.simonandschuster.com/MONEY-Master-the-Game/Tony-Robbins/9781476757803 Money, Master the Game: 7 Steps to Financial Freedom], Simon & Schuster, New York, 2014, pp. 551-2.</ref>
-* The SkinGun is featured in DHO Health Science, 8th edition, a 2014 textbook by Louise Simmers, RN.<ref name="LSimmers">Simmers, L, et al., [https://books.google.com/books?id=hZobBQAAQBAJ&lpg=PA518&dq=%22skin%20gun%22&pg=PA518#v=onepage&q=%22skin%20gun%22&f=false DHO Health Sciences, 8th ed.], Cenage Learning, Stamford, CT, 2014, p 518.</ref>
-*[[Mashable]] featured a video of the SkinGun on their [[Facebook]] page in November 2016, garnering nearly a million shares.<ref>{{Cite web|url=https://www.facebook.com/mashable/videos/10154664312809705/|title=Mashable|website=www.facebook.com|language=en|access-date=2017-10-17}}</ref>
-==References==
-{{Reflist|2}}
-[[Category:Skin|cell gun]]
-[[Category:Medical devices]]
-[[Category:Emergency medicine]]
-[[Category:Dermatology]]
-[[Category:Stem cells]]