Deep Full-thickness Burn Injury (Disorder)Phase 1/2NCT03695939
Evaluation of Safety and Efficacy of realSKIN® (Skin Xenotransplant) for Complete Closure of Severe Burn Wounds
A Phase 1/2 study testing realSKIN (skin xenotransplant) and Human Cadaver Allograft in people with Deep Full-thickness Burn Injury (Disorder), run by XenoTherapeutics, Inc. at 2 sites in United States.
Trial summary
This is a Phase 1/2, Open-label, Multi-center, Clinical Trial to evaluate the safety, tolerability, and efficacy of realSKIN® to provide complete wound closure of severe and extensive deep-partial and full-thickness burn wounds. Approximately 25 total subjects will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Full-thickness Burn Injury (Disorder)
- What is being tested?
- realSKIN (skin xenotransplant) and Human Cadaver Allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2019to 30 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject provides written informed consent to participate in this study
- Males or females age greater than 18 years old
- Females must have a negative serum pregnancy test at Screening and at Baseline and must not be nursing
- Male and female subjects must agree to use a protocol-approved method of contraception for a minimum of 3 months following Xeno-Skin® placement, which includes a barrier method plus one or more of the following:
- Hormonal contraceptives (e.g., birth control pills, skin patches, vaginal rings, and the Depo- Provera shot)
- Intrauterine device (IUD)
Show all 13Show fewer
- Male or female condoms with spermicide
- Diaphragm with spermicide
- Permanent tubal occlusive birth control system
- Total Body Surface Area (TBSA) <30%, to include deep-partial thickness or full-thickness burn wounds
- Burn injuries would otherwise require debridement and tangential excision
- Burn injury requiring temporary grafting with human cadaver allograft skin, based on clinical judgment prior to definitive wound closure via autologous grafting
- Sufficient area of burn wound for Xeno-Skin® placement and not located on face or hands or having an engraftment site centered on high-impact areas such as joints, weight-bearing areas (e.g. soles of feet), or the inguinal region, per Investigator's judgment
Who cannot join
- Pregnant or lactating women
- Documented history of infection with human immunodeficiency virus (HIV) or other condition(s) that in the opinion of the Investigator may compromise patient safety or study objectives
- Immunosuppressive medication regimens e.g. antineoplastics, high dose steroids (> 10 mg prednisone/day), TNF alpha inhibitors, calcineurin inhibitors (cyclosporine, tacrolimus), anti-proliferative agents, and other immunomodulators
- Known allergy to penicillins (such as ampicillin), ceftazidime or aztreonam, glycopeptide antibiotics (such as vancomycin) or amphotericin B
- Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 years. Non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed
- Use of any experimental or investigational drugs within 30 days prior to placement of Xeno-Skin®
Show all 25Show fewer
- Previously received a porcine or other xenogeneic tissue product, including but not limited to: glutaraldehyde fixed porcine or bovine bioprosthetic heart valve replacements and glutaraldehyde fixed porcine dermal matrix (e.g., EZ Derm)
- BMI > 40 kg/m2
- HbA1c ≥ 7.0%
- Treatment with systemic corticosteroids within 30 days before screening (not including inhaled steroids)
- Electrical, chemical, or radiation burns
- History of chronic end stage renal disease defined as an MDRD CrCl < 15 mL/min, or receiving chronic dialysis
- History of chronic liver disease or cirrhosis (Child-Pugh Score C). Evidence of acute or chronic hepatitis B infection based on documented HBV serology testing
- Known documented history of Hepatitis B, Hepatitis C, Treponema pallidum, Cytomegalovirus, herpes or varicella zoster Note: Successfully treated hepatitis C patients without evidence of end stage liver disease is allowed. If HCV antibody reactive, then HCV RNA must be undetectable.
- Recent (within 3 months prior to study enrollment) MI, unstable angina leading to hospitalization, uncontrolled, CABG, PCI, carotid surgery or stenting, cerebrovascular accident, transient ischemic attack (TIA), endovascular procedure or surgical intervention for peripheral vascular disease or plans to undergo a major surgical or interventional procedure (eg, PCI, CABG, carotid or peripheral revascularization)
- Presence of venous or arterial vascular disorder directly affecting the area of burn wound
- Pre-existing haemolytic anemia
- Chronic malnourishment as determined by Investigator
- Significant pulmonary compromise
- Systemic anticoagulation at the time of treatment or INR > 2
- Documented evidence of wound infection at Screening or Baseline
- Evidence of sepsis and/or end organ damage
- Acute lung injury
- Life expectancy of less than 180 days
- Subject who is unable to self-consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
JMS Burn Center at Doctors Hospital
Augusta, Georgia, 30909
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: An Open-label Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of realSKIN® (Skin Xenotransplant) for Complete Closure of Severe and Extensive Deep-Partial and Full-Thickness Burn Wounds
This is a Phase 1/2, Open-label, Multi-center, Clinical Trial to evaluate the safety, tolerability, and efficacy of realSKIN® to provide complete wound closure of severe and extensive deep-partial and full-thickness burn wounds.
Approximately 25 total subjects will be enrolled. Subjects who meet eligibility criteria and provide written informed consent will receive realSKIN® placement at a single burn wound site. The designated realSKIN® product size will be placed on the burn wound following wound site preparation, including necessary debridement and tangential excision as determined by burn surgeon and secured in place via suturing or stapling. The remaining burn wound will be covered with human cadaver allograft and treated according to local standard of care with care to avoid any overlap or significant contact of the two temporary wound dressings. The Investigator will assess the wounds and identify the matched pair of burn sites then the treatments will be randomly assigned to the sites.
Read more
realSKIN® will remain in place until intentional removal per Investigator's direction consistent with subject's overall clinical course, or if it is deemed to no longer provide effective wound closure and barrier function to the wound bed. The Investigator will follow local standard of care relevant to wound care and dressing changes while the realSKIN® is in place. Standard of care burn management will be provided by the Investigator.
Routine vital sign assessments, photography, laboratory tests (hematology, chemistry, and urinalysis), physical exams, and adverse event monitoring will occur while realSKIN® is in place and for up to 1 year following initial placement. Subjects will be monitored via a passive and active screening program using blood samples collected at time points throughout the study period, as adapted from FDA Guidance for Industry.
The risk of transmission of infectious disease is expected to be extremely low and while limited human trial data are available there have been no reports of transmission of porcine microorganisms to humans, and to date, there have been no adverse events (AEs) related to the use of realSKIN® observed or reported, and independent analysis of PERV data and medical records by the Safety Review Committee has indicated no evidence of zoonotic transmission in this trial.
Read the detailed description
Product Name: realSKIN®
Chemical Name: alpha-1,3-galactosyltransferase knock-out (GalT-KO) porcine (Sus scrofa) epidermal and dermal layers.
Chemical Structure: realSKIN® a biologically active, split-thickness, xenotransplantation skin product. realSKIN® is derived from specialized, genetically engineered (alpha 1,3 galactosyltransferase knockout [GalT-KO]), Designated Pathogen Free (DPF), porcine donors, containing vital, metabolically active (i.e., non-terminally sterilized) porcine cells within the dermal and epidermal tissue layers.
Proposed Indication: realSKIN is indicated for the treatment of mixed-depth, full-thickness burn wounds requiring hospitalization, surgical excision, and skin grafting.
Drug Type: realSKIN® is classified as a Live Biotherapeutic Product (LBP). (Guidance to Industry, Early Clinical Trials with Live Biotherapeutic Products, Section 1.b.)
Active Ingredient: Live (i.e. non-terminally sterilized) porcine cells, including endothelial cells of intact vasculature and those comprising the dermal and epidermal tissue layers
Product Structure: realSKIN® has an approximate thickness of 0.022 inches (0.55mm) and is currently provided in one investigational size: approximately 5x15 cm2 (22.5g/75 cm2).
Formulation: Each lot or releasable batch of realSKIN® is derived from a single source animal and each batch is independently processed and tested for various adventitious agents, histology, morphology, sterility, and purity.
Route of Administration: Surgical engraftment, via sutures or staples
Dosing Regimen: A single topical application of realSKIN has an approximate size of 150 cm2, with dimensions of 5 cm x 15 cm, meshed in a 2:1 ratio, and has an approximate thickness of 0.022 inches (0.55 mm).
realSKIN is intended for a one-time, topical application to a surgically prepared wound bed via sutures or staples and may be trimmed to fit the shape and size of the actual wound area. realSKIN can be used in the treatment of an overall injury size of up to 30% TBSA burn injury.
Drug's Mechanism of Action: realSKIN is intended for topical use directly on debrided, severe and extensive, mixed-depth and full-thickness burn wounds to provide complete and durable wound closure.
As a living skin transplant, realSKIN forms microvascular connections with host vessels in the burn wound bed which leads to wound closure. realSKIN replaces elements of whole, living skin that are analogous and functionally equivalent to those found in healthy human skin. realSKIN does not remain permanently engrafted but is replaced by the patient's own cells over time.
This mechanism of action distinguishes realSKIN from traditional xenograft products which are terminally sterilized, rendering the cells inactive, limiting their therapeutic capability to effect complete and durable wound closure.
Drug Packaging: Each realSKIN® product is individually packaged in a clear plastic, externally threaded, 10-ml polypropylene vial with threaded seal-cap, stored on a rolled, sterile nylon mesh backing on the dermal-side of the realSKIN® product that serves to support and protect the graft during processing and transport. Within this container, each realSKIN® product is individually immersed in 7-ml of sterile cryoprotective medium with 5% dimethyl sulfoxide (DMSO) (CryoStor CS5, BioLifeSolutions). Source animal serum is NOT included or used in this process. The contents are cryopreserved via controlled rate, phase freezer and stored at -80o C until use. All packaging materials are removed prior to the surgical procedure and dressing placement.
- Being tested
- realSKIN (skin xenotransplant), Human Cadaver Allograft
- Keywords
- xenotransplant, skin, burns, temporary, allograft, porcine, closure, dressing, live biotherapeutic, xenograft, pig, genetically engineered, alpha-Gal, GalT-KO
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
realSKIN (skin xenotransplant)Biological
3+3 Dose-escalation Study Design; 2 dosage strengths will be utilized during this Phase 1/2 Trial; an expansion cohort (9 patients) receive the highest dose.
Human Cadaver AllograftBiological
Also called Human Allograft Skin, HCA
HCA is used as a temporary wound dressing between debridement and definitive closure in many well-resourced contexts.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment: realSKIN (skin xenotransplant) | Experimental | In the experimental arm, patients are treated with the investigational drug, realSKIN®, in a side-by-side comparison to the active comparator, thus, each patient serves as their own control. The designated realSKIN® product size will be placed on the burn wound and secured in place via suturing or stapling. The Investigator will assess the wounds and identify the matched pair of burn sites then the treatments will be randomly assigned to the sites. Receives: Biological: realSKIN (skin xenotransplant) |
| Active Comparator: Human Allograft Skin | Active comparator | In the active comparator arm, patients are treated with human cadaver allograft, in a side-by-side comparison to the investigational drug, thus, each patient serves as their own control.
The allograft active comparator will be placed adjacently to the investigational drug, in the same anatomical location, on wound sites following debridement and secured via suture or staples. All other treatment aspects were consistent with the standard of care. The Investigator will assess the wounds and identify the matched pair of burn sites then the treatments will be randomly assigned to the sites. Receives: Biological: Human Cadaver Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporary Wound Closure
To assess the capability of realSKIN® to improve wound healing by providing supportive care until definitive closure can be accomplished by functioning as a barrier, much like human skin, as compared to similar wound site(s) treated with human cadaver allograft (HCA).
Measured: Prior to autograft placement (within 14 days)
Long-term Safety and Tolerability
To further demonstrate the long-term safety and tolerability of realSKIN®, to include evidence that Xeno-Skin® does not significantly impede wound healing.
Measured: Prior to autograft placement (continued follow up through 6 months)
Secondary outcomes (2)
Definitive Wound Closure
To assess the quality of healing, to include scarring, contour and feel of healed skin, or normalization of skin markings or pigmentation, at wound treatment sites that received temporary closure with realSKIN®, as compared to that of wound treatment site(s) that received temporary closure with human cadaver allograft (HCA).
Measured: Post autograft placement (continued follow up through 1 year)
Improved Wound Healing
To assess the capability of realSKIN® to improve wound healing by providing supportive care until definitive closure can be accomplished by functioning as a barrier, much like human skin, as compared to similar wound site(s) treated with human cadaver allograft (HCA).
Measured: Post autograft placement (continued follow up through 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start15 Mar 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Deep Full-thickness Burn Injury (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a Phase 1/2, Open-label, Multi-center, Clinical Trial to evaluate the safety, tolerability, and efficacy of realSKIN® to provide complete wound closure of severe and extensive deep-partial or full-thickness burn wounds. Approximately 25 total subjects will be enrolled. The designated realSKIN® product size will be placed on the burn wound following wound site preparation, including necessary debridement and tangential excision as determined by burn surgeon and secured in place via suturing or stapling. The remaining burn wound will be covered with human cadaver allograft and treated according to local standard of care with care to avoid any overlap or significant contact of the two temporary wound dressings. The Investigator will assess the wounds and identify the matched pair of burn sites then the treatments will be randomly assigned to the sites.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- XenoTherapeutics, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Joseph M. Still Research Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeremy Goverman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695939
- Sponsor's protocol ID
- 2018P001839
- Status last verified
- Dec 2023
- First submitted
- 28 Sep 2018
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albritton A, Leonard DA, Leto Barone A, Keegan J, Mallard C, Sachs DH, Kurtz JM, Cetrulo CL Jr. Lack of cross-sensitization between alpha-1,3-galactosyltransferase knockout porcine and allogeneic skin grafts permits serial grafting. Transplantation. 2014 Jun 27;97(12):1209-15. doi: 10.1097/TP.0000000000000093.
PubMed 24798308Bruccoleri RE, Matthew MK, Schulz JT. Methods in obtaining split-thickness skin grafts from skin reduction surgery specimens. Springerplus. 2016 May 25;5(1):690. doi: 10.1186/s40064-016-2330-2. eCollection 2016.
PubMed 27350924Burd A, Chiu T. Allogenic skin in the treatment of burns. Clin Dermatol. 2005 Jul-Aug;23(4):376-87. doi: 10.1016/j.clindermatol.2004.07.019.
PubMed 16023933Denner J. Paving the Path toward Porcine Organs for Transplantation. N Engl J Med. 2017 Nov 9;377(19):1891-1893. doi: 10.1056/NEJMcibr1710853. No abstract available.
PubMed 29117497Deschamps JY, Roux FA, Sai P, Gouin E. History of xenotransplantation. Xenotransplantation. 2005 Mar;12(2):91-109. doi: 10.1111/j.1399-3089.2004.00199.x.
PubMed 15693840Ericsson TA, Takeuchi Y, Templin C, Quinn G, Farhadian SF, Wood JC, Oldmixon BA, Suling KM, Ishii JK, Kitagawa Y, Miyazawa T, Salomon DR, Weiss RA, Patience C. Identification of receptors for pig endogenous retrovirus. Proc Natl Acad Sci U S A. 2003 May 27;100(11):6759-64. doi: 10.1073/pnas.1138025100. Epub 2003 May 9.
PubMed 12740431Fishman JA. Screening of source animals and clinical monitoring for xenotransplantation. Xenotransplantation. 2007, 349-352.
Fishman JA, Scobie L, Takeuchi Y. Xenotransplantation-associated infectious risk: a WHO consultation. Xenotransplantation. 2012 Mar-Apr;19(2):72-81. doi: 10.1111/j.1399-3089.2012.00693.x.
PubMed 22497509Godehardt AW, Rodrigues Costa M, Tonjes RR. Review on porcine endogenous retrovirus detection assays--impact on quality and safety of xenotransplants. Xenotransplantation. 2015 Mar-Apr;22(2):95-101. doi: 10.1111/xen.12154. Epub 2015 Jan 31.
PubMed 25641488Herndon DN. Total Burn Care, Expert Consult - Online. Elsevier Health Sciences; 2012.
Johnson RM, Richard R. Partial-thickness burns: identification and management. Adv Skin Wound Care. 2003 Jul-Aug;16(4):178-87; quiz 188-9. doi: 10.1097/00129334-200307000-00010.
PubMed 12897674Kitala D, Kawecki M, Klama-Baryla A, Labus W, Kraut M, Glik J, Ryszkiel I, Kawecki MP, Nowak M. Allogeneic vs. Autologous Skin Grafts in the Therapy of Patients with Burn Injuries: A Restrospective, Open-label Clinical Study with Pair Matching. Adv Clin Exp Med. 2016 Sep-Oct;25(5):923-929. doi: 10.17219/acem/61961.
PubMed 28028957Leonard DA, Mallard C, Albritton A, Torabi R, Mastroianni M, Sachs DH, Kurtz JM, Cetrulo CL Jr. Skin grafts from genetically modified alpha-1,3-galactosyltransferase knockout miniature swine: A functional equivalent to allografts. Burns. 2017 Dec;43(8):1717-1724. doi: 10.1016/j.burns.2017.04.026. Epub 2017 Jun 8.
PubMed 28602591Leto Barone AA, Mastroianni M, Farkash EA, Mallard C, Albritton A, Torabi R, Leonard DA, Kurtz JM, Sachs DH, Cetrulo CL Jr. Genetically modified porcine split-thickness skin grafts as an alternative to allograft for provision of temporary wound coverage: preliminary characterization. Burns. 2015 May;41(3):565-74. doi: 10.1016/j.burns.2014.09.003. Epub 2014 Oct 16.
PubMed 25406888Organ Procurement and Transplantation Network. (n.d.). Retrieved May 01, 2017, from https://optn.transplant.hrsa.gov/
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of realSKIN® (Skin Xenotransplant) for Complete Closure of Severe and Extensive Deep-Partial and Full-Thickness Burn Wounds
- ClinicalTrials.gov ID
- NCT03695939
- Acronym / sponsor ID
- 2018P001839
- Keywords
- xenotransplant, skin, burns, temporary, allograft, porcine, closure, dressing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- XenoTherapeutics, Inc.University, hospital or other
- Collaborators
- Massachusetts General Hospital, Joseph M. Still Research Foundation, Inc.
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1/2, Open-label, Multi-center, Clinical Trial to evaluate the safety, tolerability, and efficacy of realSKIN® to provide complete wound closure of severe and extensive deep-partial and full-thickness burn wounds.
Approximately 25 total subjects will be enrolled. Subjects who meet eligibility criteria and provide written informed consent will receive realSKIN® placement at a single burn wound site. The designated realSKIN® product size will be placed on the burn wound following wound site preparation, including necessary debridement and tangential excision as determined by burn surgeon and secured in place via suturing or stapling. The remaining burn wound will be covered with human cadaver allograft and treated according to local standard of care with care to avoid any overlap or significant contact of the two temporary wound dressings. The Investigator will assess the wounds and identify the matched pair of burn sites then the treatments will be randomly assigned to the sites.
realSKIN® will remain in place until intentional removal per Investigator's direction consistent with subject's overall clinical course, or if it is deemed to no longer provide effective wound closure and barrier function to the wound bed. The Investigator will follow local standard of care relevant to wound care and dressing changes while the realSKIN® is in place. Standard of care burn management will be provided by the Investigator.
Routine vital sign assessments, photography, laboratory tests (hematology, chemistry, and urinalysis), physical exams, and adverse event monitoring will occur while realSKIN® is in place and for up to 1 year following initial placement. Subjects will be monitored via a passive and active screening program using blood samples collected at time points throughout the study period, as adapted from FDA Guidance for Industry.
The risk of transmission of infectious disease is expected to be extremely low and while limited human trial data are available there have been no reports of transmission of porcine microorganisms to humans, and to date, there have been no adverse events (AEs) related to the use of realSKIN® observed or reported, and independent analysis of PERV data and medical records by the Safety Review Committee has indicated no evidence of zoonotic transmission in this trial.
Detailed description
Product Name: realSKIN®
Chemical Name: alpha-1,3-galactosyltransferase knock-out (GalT-KO) porcine (Sus scrofa) epidermal and dermal layers.
Chemical Structure: realSKIN® a biologically active, split-thickness, xenotransplantation skin product. realSKIN® is derived from specialized, genetically engineered (alpha 1,3 galactosyltransferase knockout [GalT-KO]), Designated Pathogen Free (DPF), porcine donors, containing vital, metabolically active (i.e., non-terminally sterilized) porcine cells within the dermal and epidermal tissue layers.
Proposed Indication: realSKIN is indicated for the treatment of mixed-depth, full-thickness burn wounds requiring hospitalization, surgical excision, and skin grafting.
Drug Type: realSKIN® is classified as a Live Biotherapeutic Product (LBP). (Guidance to Industry, Early Clinical Trials with Live Biotherapeutic Products, Section 1.b.)
Active Ingredient: Live (i.e. non-terminally sterilized) porcine cells, including endothelial cells of intact vasculature and those comprising the dermal and epidermal tissue layers
Product Structure: realSKIN® has an approximate thickness of 0.022 inches (0.55mm) and is currently provided in one investigational size: approximately 5x15 cm2 (22.5g/75 cm2).
Formulation: Each lot or releasable batch of realSKIN® is derived from a single source animal and each batch is independently processed and tested for various adventitious agents, histology, morphology, sterility, and purity.
Route of Administration: Surgical engraftment, via sutures or staples
Dosing Regimen: A single topical application of realSKIN has an approximate size of 150 cm2, with dimensions of 5 cm x 15 cm, meshed in a 2:1 ratio, and has an approximate thickness of 0.022 inches (0.55 mm).
realSKIN is intended for a one-time, topical application to a surgically prepared wound bed via sutures or staples and may be trimmed to fit the shape and size of the actual wound area. realSKIN can be used in the treatment of an overall injury size of up to 30% TBSA burn injury.
Drug's Mechanism of Action: realSKIN is intended for topical use directly on debrided, severe and extensive, mixed-depth and full-thickness burn wounds to provide complete and durable wound closure.
As a living skin transplant, realSKIN forms microvascular connections with host vessels in the burn wound bed which leads to wound closure. realSKIN replaces elements of whole, living skin that are analogous and functionally equivalent to those found in healthy human skin. realSKIN does not remain permanently engrafted but is replaced by the patient's own cells over time.
This mechanism of action distinguishes realSKIN from traditional xenograft products which are terminally sterilized, rendering the cells inactive, limiting their therapeutic capability to effect complete and durable wound closure.
Drug Packaging: Each realSKIN® product is individually packaged in a clear plastic, externally threaded, 10-ml polypropylene vial with threaded seal-cap, stored on a rolled, sterile nylon mesh backing on the dermal-side of the realSKIN® product that serves to support and protect the graft during processing and transport. Within this container, each realSKIN® product is individually immersed in 7-ml of sterile cryoprotective medium with 5% dimethyl sulfoxide (DMSO) (CryoStor CS5, BioLifeSolutions). Source animal serum is NOT included or used in this process. The contents are cryopreserved via controlled rate, phase freezer and stored at -80o C until use. All packaging materials are removed prior to the surgical procedure and dressing placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Phase 1/2, Open-label, Multi-center, Clinical Trial to evaluate the safety, tolerability, and efficacy of realSKIN® to provide complete wound closure of severe and extensive deep-partial or full-thickness burn wounds. Approximately 25 total subjects will be enrolled. The designated realSKIN® product size will be placed on the burn wound following wound site preparation, including necessary debridement and tangential excision as determined by burn surgeon and secured in place via suturing or stapling. The remaining burn wound will be covered with human cadaver allograft and treated according to local standard of care with care to avoid any overlap or significant contact of the two temporary wound dressings. The Investigator will assess the wounds and identify the matched pair of burn sites then the treatments will be randomly assigned to the sites.
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment: realSKIN (skin xenotransplant) | Experimental | Biological: realSKIN (skin xenotransplant)In the experimental arm, patients are treated with the investigational drug, realSKIN®, in a side-by-side comparison to the active comparator, thus, each patient serves as their own control. The designated realSKIN® product size will be placed on the burn wound and secured in place via suturing or stapling. The Investigator will assess the wounds and identify the matched pair of burn sites then the treatments will be randomly assigned to the sites. |
| Active Comparator: Human Allograft Skin | Active comparator | Biological: Human Cadaver AllograftIn the active comparator arm, patients are treated with human cadaver allograft, in a side-by-side comparison to the investigational drug, thus, each patient serves as their own control. The allograft active comparator will be placed adjacently to the investigational drug, in the same anatomical location, on wound sites following debridement and secured via suture or staples. All other treatment aspects were consistent with the standard of care. The Investigator will assess the wounds and identify the matched pair of burn sites then the treatments will be randomly assigned to the sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The subject provides written informed consent to participate in this study
- Males or females age greater than 18 years old
- Females must have a negative serum pregnancy test at Screening and at Baseline and must not be nursing
- Male and female subjects must agree to use a protocol-approved method of contraception for a minimum of 3 months following Xeno-Skin® placement, which includes a barrier method plus one or more of the following:
- Total Body Surface Area (TBSA) <30%, to include deep-partial thickness or full-thickness burn wounds
Key exclusion criteria (25 listed)
- Pregnant or lactating women
- Documented history of infection with human immunodeficiency virus (HIV) or other condition(s) that in the opinion of the Investigator may compromise patient safety or study objectives
- Immunosuppressive medication regimens e.g. antineoplastics, high dose steroids (> 10 mg prednisone/day), TNF alpha inhibitors, calcineurin inhibitors (cyclosporine, tacrolimus), anti-proliferative agents, and other immunomodulators
- Known allergy to penicillins (such as ampicillin), ceftazidime or aztreonam, glycopeptide antibiotics (such as vancomycin) or amphotericin B
- Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 years. Non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| realSKIN (skin xenotransplant)3+3 Dose-escalation Study Design; 2 dosage strengths will be utilized during this Phase 1/2 Trial; an expansion cohort (9 patients) receive the highest dose. | Biological | Experimental Treatment: realSKIN (skin xenotransplant) |
| Human Cadaver AllograftAlso: Human Allograft Skin, HCAHCA is used as a temporary wound dressing between debridement and definitive closure in many well-resourced contexts. | Biological | Active Comparator: Human Allograft Skin |
Primary outcome
Temporary Wound Closure
Time frame: Prior to autograft placement (within 14 days)
To assess the capability of realSKIN® to improve wound healing by providing supportive care until definitive closure can be accomplished by functioning as a barrier, much like human skin, as compared to similar wound site(s) treated with human cadaver allograft (HCA).
Long-term Safety and Tolerability
Time frame: Prior to autograft placement (continued follow up through 6 months)
To further demonstrate the long-term safety and tolerability of realSKIN®, to include evidence that Xeno-Skin® does not significantly impede wound healing.
2 secondary outcomes
Definitive Wound Closure
Time frame: Post autograft placement (continued follow up through 1 year)
Improved Wound Healing
Time frame: Post autograft placement (continued follow up through 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 24798308Albritton A, Leonard DA, Leto Barone A, Keegan J, Mallard C, Sachs DH, Kurtz JM, Cetrulo CL Jr. Lack of cross-sensitization between alpha-1,3-galactosyltransferase knockout porcine and allogeneic skin grafts permits serial grafting. Transplantation. 2014 Jun 27;97(12):1209-15. doi: 10.1097/TP.0000000000000093.
- Background: PubMed 27350924Bruccoleri RE, Matthew MK, Schulz JT. Methods in obtaining split-thickness skin grafts from skin reduction surgery specimens. Springerplus. 2016 May 25;5(1):690. doi: 10.1186/s40064-016-2330-2. eCollection 2016.
- Background: PubMed 16023933Burd A, Chiu T. Allogenic skin in the treatment of burns. Clin Dermatol. 2005 Jul-Aug;23(4):376-87. doi: 10.1016/j.clindermatol.2004.07.019.
- Background: PubMed 29117497Denner J. Paving the Path toward Porcine Organs for Transplantation. N Engl J Med. 2017 Nov 9;377(19):1891-1893. doi: 10.1056/NEJMcibr1710853. No abstract available.
- Background: PubMed 15693840Deschamps JY, Roux FA, Sai P, Gouin E. History of xenotransplantation. Xenotransplantation. 2005 Mar;12(2):91-109. doi: 10.1111/j.1399-3089.2004.00199.x.
- Background: PubMed 12740431Ericsson TA, Takeuchi Y, Templin C, Quinn G, Farhadian SF, Wood JC, Oldmixon BA, Suling KM, Ishii JK, Kitagawa Y, Miyazawa T, Salomon DR, Weiss RA, Patience C. Identification of receptors for pig endogenous retrovirus. Proc Natl Acad Sci U S A. 2003 May 27;100(11):6759-64. doi: 10.1073/pnas.1138025100. Epub 2003 May 9.
- BackgroundFishman JA. Screening of source animals and clinical monitoring for xenotransplantation. Xenotransplantation. 2007, 349-352.
- Background: PubMed 22497509Fishman JA, Scobie L, Takeuchi Y. Xenotransplantation-associated infectious risk: a WHO consultation. Xenotransplantation. 2012 Mar-Apr;19(2):72-81. doi: 10.1111/j.1399-3089.2012.00693.x.
- Background: PubMed 25641488Godehardt AW, Rodrigues Costa M, Tonjes RR. Review on porcine endogenous retrovirus detection assays--impact on quality and safety of xenotransplants. Xenotransplantation. 2015 Mar-Apr;22(2):95-101. doi: 10.1111/xen.12154. Epub 2015 Jan 31.
- BackgroundHerndon DN. Total Burn Care, Expert Consult - Online. Elsevier Health Sciences; 2012.
- Background: PubMed 12897674Johnson RM, Richard R. Partial-thickness burns: identification and management. Adv Skin Wound Care. 2003 Jul-Aug;16(4):178-87; quiz 188-9. doi: 10.1097/00129334-200307000-00010.
- Background: PubMed 28028957Kitala D, Kawecki M, Klama-Baryla A, Labus W, Kraut M, Glik J, Ryszkiel I, Kawecki MP, Nowak M. Allogeneic vs. Autologous Skin Grafts in the Therapy of Patients with Burn Injuries: A Restrospective, Open-label Clinical Study with Pair Matching. Adv Clin Exp Med. 2016 Sep-Oct;25(5):923-929. doi: 10.17219/acem/61961.
- Individual participant dataSharing planned: No
Related trials for Deep Full-thickness Burn Injury (Disorder)
RecruitingPhase 3
Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
Burns Degree Third, Burn (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Goverman, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing realSKIN (skin xenotransplant) and Human Cadaver Allograft in people with Deep Full-thickness Burn Injury (Disorder), run by XenoTherapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporary Wound Closure (time frame: Prior to autograft placement (within 14 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695939, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.