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Trial record 1 of 1 for:    NCT03695939
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Evaluation of Safety, Tolerability and Efficacy of Xeno-Skin® for Temporary Closure of Severe Burn Wounds

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ClinicalTrials.gov Identifier: NCT03695939
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : October 21, 2021
Sponsor:
Collaborators:
Massachusetts General Hospital
Joseph M. Still Research Foundation, Inc.
Information provided by (Responsible Party):
XenoTherapeutics, Inc.

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.


Condition or disease Intervention/treatment Phase
Deep Full-thickness Burn Injury (Disorder) Biological: Xeno-Skin™ Biological: Human Cadaver Allograft Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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. 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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Treatment: Xeno-Skin®
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.
Biological: Xeno-Skin™
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.

Active Comparator: Active Comparator: Human Allograft Skin

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.

Biological: Human Cadaver Allograft
HCA is used as a temporary wound dressing between debridement and definitive closure in many well-resourced contexts.
Other Names:
  • Human Allograft Skin
  • HCA




Primary Outcome Measures :
  1. Temporary Wound Closure [ Time Frame: Prior to autograft placement (within 14 days) ]
    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).

  2. 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 Xeno-Skin®, to include evidence that Xeno-Skin® does not significantly impede wound healing.


Secondary Outcome Measures :
  1. Definitive Wound Closure [ Time Frame: Post autograft placement (continued follow up through 1 year) ]
    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).

  2. Improved Wound Healing [ Time Frame: Post autograft placement (continued follow up through 1 year) ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject provides written informed consent to participate in this study
  2. Males or females age greater than 18 years old
  3. Females must have a negative serum pregnancy test at Screening and at Baseline and must not be nursing
  4. 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
  5. Total Body Surface Area (TBSA) <30%, to include deep-partial thickness or full-thickness burn wounds
  6. Burn injuries would otherwise require debridement and tangential excision
  7. Burn injury requiring temporary grafting with human cadaver allograft skin, based on clinical judgment prior to definitive wound closure via autologous grafting
  8. 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:

  1. Pregnant or lactating women
  2. 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
  3. 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
  4. Known allergy to penicillins (such as ampicillin), ceftazidime or aztreonam, glycopeptide antibiotics (such as vancomycin) or amphotericin B
  5. 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
  6. Use of any experimental or investigational drugs within 30 days prior to placement of Xeno-Skin®
  7. 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)
  8. BMI > 40 kg/m2
  9. HbA1c ≥ 7.0%
  10. Treatment with systemic corticosteroids within 30 days before screening (not including inhaled steroids)
  11. Electrical, chemical, or radiation burns
  12. History of chronic end stage renal disease defined as an MDRD CrCl < 15 mL/min, or receiving chronic dialysis
  13. 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
  14. 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.
  15. 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)
  16. Presence of venous or arterial vascular disorder directly affecting the area of burn wound
  17. Pre-existing haemolytic anemia
  18. Chronic malnourishment as determined by Investigator
  19. Significant pulmonary compromise
  20. Systemic anticoagulation at the time of treatment or INR > 2
  21. Documented evidence of wound infection at Screening or Baseline
  22. Evidence of sepsis and/or end organ damage
  23. Acute lung injury
  24. Life expectancy of less than 180 days
  25. Subject who is unable to self-consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695939


Contacts
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Contact: Jon Adkins, MBA (617) 939-7892 clinicaltrials@xenotherapeutics.org
Contact: Adkins

Locations
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United States, Georgia
JMS Burn Center at Doctors Hospital Not yet recruiting
Augusta, Georgia, United States, 30909
Contact: Joan Wilson, MSN, MHA, RN    706-364-2966    joan.wilson@jmsresearchfoundation.org   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeremy Goverman, MD    617-726-3712      
Sponsors and Collaborators
XenoTherapeutics, Inc.
Massachusetts General Hospital
Joseph M. Still Research Foundation, Inc.
Investigators
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Principal Investigator: Jeremy Goverman, MD Massachusetts General Hospital
Publications:
Fishman JA. Screening of source animals and clinical monitoring for xenotransplantation. Xenotransplantation. 2007, 349-352.
Herndon DN. Total Burn Care, Expert Consult - Online. Elsevier Health Sciences; 2012.
Organ Procurement and Transplantation Network. (n.d.). Retrieved May 01, 2017, from https://optn.transplant.hrsa.gov/
Schaffer A. Cadaver Skin Fills the Gap in Burn Cases. New York Times. May 2, 2006.
Thorton JF and Gosman AA. Skin Grafts and Skin Substitutes. Baylor University Medical Center. 2004 10(1): 2-78
World Health Organization Burn Fact Sheet. http://www.who.int/en/news-room/fact-sheets/detail/burns. March 6, 2018.

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Responsible Party: XenoTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03695939    
Other Study ID Numbers: 2018P001839
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by XenoTherapeutics, Inc.:
xenotransplant
skin
burns
temporary
allograft
porcine
closure
dressing
live biotherapeutic
xenograft
pig
genetically engineered
alpha-Gal
GalT-KO
Additional relevant MeSH terms:
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Burns
Wounds and Injuries