Back to results

Evaluation of Safety, Tolerability and Efficacy of Xeno-Skin® for Temporary Closure of Severe Burn Wounds

Primary Purpose

Deep Full-thickness Burn Injury (Disorder)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Xeno-Skin™

Human Cadaver Allograft

About this trial

This is an interventional treatment trial for Deep Full-thickness Burn Injury (Disorder) focused on measuring xenotransplant, skin, burns, temporary, allograft, porcine, closure, dressing, live biotherapeutic, xenograft, pig, genetically engineered, alpha-Gal, GalT-KO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. Hormonal contraceptives (e.g., birth control pills, skin patches, vaginal rings, and the Depo- Provera shot)
2. Intrauterine device (IUD)
3. Male or female condoms with spermicide
4. Diaphragm with spermicide
5. 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

Exclusion Criteria:

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®
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

Sites / Locations

JMS Burn Center at Doctors Hospital
Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Treatment: Xeno-Skin®

Active Comparator: Human Allograft Skin

Arm Description

In the experimental arm, patients are treated with the investigational drug, Xeno-Skin®, in a side-by-side comparison to the active comparator, thus, each patient serves as their own control. The designated Xeno-Skin® 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.

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.

Outcomes

Primary Outcome Measures

Temporary Wound Closure

To assess the capability of Xeno-Skin® 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

To further demonstrate the long-term safety and tolerability of Xeno-Skin®, to include evidence that Xeno-Skin® does not significantly impede wound healing.

Secondary Outcome Measures

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 Xeno- Skin®, as compared to that of wound treatment site(s) that received temporary closure with human cadaver allograft (HCA).

Improved Wound Healing

Full Information

NCT ID

NCT03695939

First Posted

September 28, 2018

Last Updated

June 28, 2022

Sponsor

XenoTherapeutics, Inc.

Collaborators

Massachusetts General Hospital, Joseph M. Still Research Foundation, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03695939

Brief Title

Evaluation of Safety, Tolerability and Efficacy of Xeno-Skin® for Temporary Closure of Severe Burn Wounds

Official Title

An Open-label Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of Xeno-Skin® for Temporary Closure of Severe and Extensive Deep-Partial and Full-Thickness Burn Wounds

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

March 15, 2019 (Actual)

Primary Completion Date

June 6, 2022 (Actual)

Study Completion Date

June 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

XenoTherapeutics, Inc.

Collaborators

Massachusetts General Hospital, Joseph M. Still Research Foundation, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a Phase 1/2, Open-label, Multi-center, Clinical Trial to evaluate the safety, tolerability, and efficacy of Xeno-Skin® to provide temporary wound closure of severe and extensive deep-partial or full-thickness burn wounds until definitive wound closure can be achieved via permanent autografting. Approximately 15 total subjects will be enrolled. Subjects who meet eligibility criteria and provide written informed consent will receive Xeno-Skin® placement at a single burn wound site. The designated Xeno-Skin® 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. Xeno-Skin® 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 Xeno- Skin® 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 Xeno-Skin® 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 Xeno-Skin® 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: Xeno-Skin® Chemical Name: alpha-1,3-galactosyltransferase knock-out (GalT-KO) porcine (Sus scrofa) split-thickness skin Chemical Structure: Xeno-Skin® is a live biotherapeutic, split-thickness, xenotransplantation skin product derived from specialized, genetically engineered (alpha 1,3 galactosyltransferase knockout [GalT-KO]), Designated Pathogen Free (DPF), porcine donors containing live (i.e. non-terminally sterilized) porcine cells, including endothelial cells of intact vasculature and those comprising the dermal and epidermal tissue layers. Proposed Indication: Xeno-Skin® is indicated for the treatment of a serious condition and unmet medical need: severe and extensive deep-partial and full-thickness burn wounds requiring hospitalization, surgical excision, and skin grafting. Drug Type: Xeno-Skin® 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: Xeno-Skin® 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 Xeno-Skin® 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: Surgical engraftment, via sutures or staples, to provide temporary wound closure of severe and extensive deep-partial and full-thickness burn wounds requiring hospitalization, surgical excision, and skin grafting. The amount is of temporary wound dressing is based on the depth and size (TBSA) of the burn injury. Drug's Mechanism of Action: Patients with severe burns are at high risk of mortality due to a devastating sequela of complications such as increased capillary leak and release of inflammatory cytokines, infection from opportunistic pathogens, immune-compromise, hypovolemia, hypothermia, electrolyte and pH imbalances, and other detrimental deviations to pre-injury homeostasis as a result of a disruption in the skin barrier that contributes to organ failure and often death. Xeno-Skin® provides a temporary barrier against infection, helps prevent fluid loss, and helps restore the functional skin barrier prior to definitive wound closure with the placement of an autograft. Xeno-Skin®'s inclusion of viable epithelial, epidermal, and dermal porcine cells permits revascularization of the wound bed, critical for efficient re-epithelialization and wound healing. This mechanism of action closely mirrors today's clinical standard, human cadaver allograft. The same progression of wound healing processes occurs in both human cadaver allograft and Xeno-Skin®. This mechanism of action distinguishes Xeno-Skin® from traditional xenografts products on the market today, which are terminally sterilized, rendering the cells inactive, limiting their therapeutic capability. Drug Packaging: Each Xeno-Skin® 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 Xeno-Skin® product that serves to support and protect the graft during processing and transport. Within this container, each Xeno-Skin® 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Full-thickness Burn Injury (Disorder)

Keywords

xenotransplant, skin, burns, temporary, allograft, porcine, closure, dressing, live biotherapeutic, xenograft, pig, genetically engineered, alpha-Gal, GalT-KO

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Treatment: Xeno-Skin®

Arm Type

Experimental

Arm Description

Arm Title

Active Comparator: Human Allograft Skin

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Xeno-Skin™

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Human Cadaver Allograft

Other Intervention Name(s)

Human Allograft Skin, HCA

Intervention Description

HCA is used as a temporary wound dressing between debridement and definitive closure in many well-resourced contexts.

Primary Outcome Measure Information:

Title

Temporary Wound Closure

Description

Time Frame

Prior to autograft placement (within 14 days)

Title

Long-term Safety and Tolerability

Description

To further demonstrate the long-term safety and tolerability of Xeno-Skin®, to include evidence that Xeno-Skin® does not significantly impede wound healing.

Time Frame

Prior to autograft placement (continued follow up through 6 months)

Secondary Outcome Measure Information:

Title

Definitive Wound Closure

Description

Time Frame

Post autograft placement (continued follow up through 1 year)

Title

Improved Wound Healing

Description

Time Frame

Post autograft placement (continued follow up through 1 year)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) 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 Exclusion Criteria: 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® 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeremy Goverman, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

JMS Burn Center at Doctors Hospital

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24798308

Citation

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.

Results Reference

background

PubMed Identifier

27350924

Citation

Bruccoleri 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.

Results Reference

background

PubMed Identifier

16023933

Citation

Burd 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.

Results Reference

background

PubMed Identifier

29117497

Citation

Denner 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.

Results Reference

background

PubMed Identifier

15693840

Citation

Deschamps 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.

Results Reference

background

PubMed Identifier

12740431

Citation

Ericsson 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.

Results Reference

background

Citation

Fishman JA. Screening of source animals and clinical monitoring for xenotransplantation. Xenotransplantation. 2007, 349-352.

Results Reference

background

PubMed Identifier

22497509

Citation

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.

Results Reference

background

PubMed Identifier

25641488

Citation

Godehardt 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.

Results Reference

background

Citation

Herndon DN. Total Burn Care, Expert Consult - Online. Elsevier Health Sciences; 2012.

Results Reference

background

PubMed Identifier

12897674

Citation

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.

Results Reference

background

PubMed Identifier

28028957

Citation

Kitala 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.

Results Reference

background

PubMed Identifier

28602591

Citation

Leonard 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.

Results Reference

background

PubMed Identifier

25406888

Citation

Leto 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.

Results Reference

background

Citation

Organ Procurement and Transplantation Network. (n.d.). Retrieved May 01, 2017, from https://optn.transplant.hrsa.gov/

Results Reference

background

PubMed Identifier

17081300

Citation

Martin SI, Wilkinson R, Fishman JA. Genomic presence of recombinant porcine endogenous retrovirus in transmitting miniature swine. Virol J. 2006 Nov 2;3:91. doi: 10.1186/1743-422X-3-91.

Results Reference

background

PubMed Identifier

20642677

Citation

Meije Y, Tonjes RR, Fishman JA. Retroviral restriction factors and infectious risk in xenotransplantation. Am J Transplant. 2010 Jul;10(7):1511-6. doi: 10.1111/j.1600-6143.2010.03146.x.

Results Reference

background

PubMed Identifier

27677465

Citation

Morozov VA, Wynyard S, Matsumoto S, Abalovich A, Denner J, Elliott R. No PERV transmission during a clinical trial of pig islet cell transplantation. Virus Res. 2017 Jan 2;227:34-40. doi: 10.1016/j.virusres.2016.08.012. Epub 2016 Sep 24.

Results Reference

background

PubMed Identifier

10455044

Citation

Paradis K, Langford G, Long Z, Heneine W, Sandstrom P, Switzer WM, Chapman LE, Lockey C, Onions D, Otto E. Search for cross-species transmission of porcine endogenous retrovirus in patients treated with living pig tissue. The XEN 111 Study Group. Science. 1999 Aug 20;285(5431):1236-41. doi: 10.1126/science.285.5431.1236.

Results Reference

background

PubMed Identifier

9055854

Citation

Patience C, Takeuchi Y, Weiss RA. Infection of human cells by an endogenous retrovirus of pigs. Nat Med. 1997 Mar;3(3):282-6. doi: 10.1038/nm0397-282.

Results Reference

background

PubMed Identifier

19708462

Citation

Sachs DH. The lure of transplantation. Clin Transpl. 2008:287-305. No abstract available.

Results Reference

background

Citation

Schaffer A. Cadaver Skin Fills the Gap in Burn Cases. New York Times. May 2, 2006.

Results Reference

background

PubMed Identifier

19903300

Citation

Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.

Results Reference

background

PubMed Identifier

10208382

Citation

Sheridan RL, Tompkins RG. Skin substitutes in burns. Burns. 1999 Mar;25(2):97-103. doi: 10.1016/s0305-4179(98)00176-4. No abstract available.

Results Reference

background

PubMed Identifier

19414036

Citation

Shi M, Wang X, Okamoto M, Takao S, Baba M. Inhibition of porcine endogenous retrovirus (PERV) replication by HIV-1 gene expression inhibitors. Antiviral Res. 2009 Aug;83(2):201-4. doi: 10.1016/j.antiviral.2009.04.011. Epub 2009 May 3.

Results Reference

background

Citation

Thorton JF and Gosman AA. Skin Grafts and Skin Substitutes. Baylor University Medical Center. 2004 10(1): 2-78

Results Reference

background

PubMed Identifier

20522247

Citation

Weiner J, Yamada K, Ishikawa Y, Moran S, Etter J, Shimizu A, Smith RN, Sachs DH. Prolonged survival of GalT-KO swine skin on baboons. Xenotransplantation. 2010 Mar-Apr;17(2):147-52. doi: 10.1111/j.1399-3089.2010.00576.x.

Results Reference

background

PubMed Identifier

12568344

Citation

Wilhelm M, Fishman JA, Pontikis R, Aubertin AM, Wilhelm FX. Susceptibility of recombinant porcine endogenous retrovirus reverse transcriptase to nucleoside and non-nucleoside inhibitors. Cell Mol Life Sci. 2002 Dec;59(12):2184-90. doi: 10.1007/s000180200017.

Results Reference

background

PubMed Identifier

14963150

Citation

Wood JC, Quinn G, Suling KM, Oldmixon BA, Van Tine BA, Cina R, Arn S, Huang CA, Scobie L, Onions DE, Sachs DH, Schuurman HJ, Fishman JA, Patience C. Identification of exogenous forms of human-tropic porcine endogenous retrovirus in miniature Swine. J Virol. 2004 Mar;78(5):2494-501. doi: 10.1128/jvi.78.5.2494-2501.2004.

Results Reference

background

Citation

World Health Organization Burn Fact Sheet. http://www.who.int/en/news-room/fact-sheets/detail/burns. March 6, 2018.

Results Reference

background

PubMed Identifier

24801820

Citation

Wynyard S, Nathu D, Garkavenko O, Denner J, Elliott R. Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand. Xenotransplantation. 2014 Jul-Aug;21(4):309-23. doi: 10.1111/xen.12102. Epub 2014 May 7.

Results Reference

background

PubMed Identifier

26439047

Citation

Yue S, Zhang Y, Gao Y. A study on the susceptibility of allogeneic human hepatocytes to porcine endogenous retrovirus. Eur Rev Med Pharmacol Sci. 2015 Sep;19(18):3486-91.

Results Reference

background

PubMed Identifier

27606556

Citation

Holzer PW, Leonard DA, Shanmugarajah K, Moulton KN, Ng ZY, Cetrulo CL Jr, Sachs DH. A Comparative Examination of the Clinical Outcome and Histological Appearance of Cryopreserved and Fresh Split-Thickness Skin Grafts. J Burn Care Res. 2017 Jan/Feb;38(1):e55-e61. doi: 10.1097/BCR.0000000000000431.

Results Reference

background

Learn more about this trial

Evaluation of Safety, Tolerability and Efficacy of Xeno-Skin® for Temporary Closure of Severe Burn Wounds

We'll reach out to this number within 24 hrs