Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    xenograft | severe burns
Previous Study | Return to List | Next Study

Evaluation of Safety of Xeno-Skin™ for Treatment of Severe and Extensive, Partial and Full Thickness Burns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03695939
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
XenoTherapeutics, Inc.

Brief Summary:
To assess the Safety and Tolerability of Xeno-Skin™ for the treatment of severe and extensive, deep partial and full thickness burn wounds as a first-line treatment, and temporary coverage prior to definitive wound closure.

Condition or disease Intervention/treatment Phase
Burn Wound Biological: Xeno-Skin™ Phase 1

Detailed Description:

This Phase 1 Study is a 2 cohort, open-label, non-randomized trial, to assess the safety and tolerability of Xeno-Skin™ for the treatment of severe and extensive, deep partial and full thickness burn wounds as a first-line treatment, and temporary coverage prior to definitive wound closure.

Subjects who meet eligibility criteria and provide informed consent will receive placement of Xeno-Skin™ on a single burn wound site.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase 1 Study to Evaluate the Safety and Tolerability of Xeno-Skin™ for Temporary Coverage of Severe and Extensive, Deep Partial and Full Thickness Burn Wounds
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Xeno-Skin™
Single arm trial
Biological: Xeno-Skin™
3+3 Dose-escalation Study Design; 2 dosage strengths will be utilized during this Phase 1 Trial




Primary Outcome Measures :
  1. Safety and Tolerability: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  2. Clinically Relevant Response [ Time Frame: daily through 4 weeks, 6 months ]
    To assess the quality and duration of temporary barrier function afforded by Xeno-Skin™(as determined by the Clinical Wound Assessment Scale, adapted from Branski et al 2011). Six characteristics are assessed: Graft dislocation; Graft adherence, Granulation tissue; Hyper-granulation; Hematoma; and Fibrin deposit. Each characteristic is assessed on an independent 0-5 scale and subscale scores are reported. It is expected that some characteristics may not be assessible at all stages of the grafting process and NA may be recorded.

  3. Time of Graft Adherence. [ Time Frame: daily through 4 weeks ]
    To assess the duration of temporary barrier function afforded by Xeno-Skin™



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 or, when applicable, the subject's legally authorized representative, provides written informed consent to participate in this study
  2. Age greater than 18 years old
  3. Male or female of non-childbearing potential. Females must be:

    a. Naturally postmenopausal defined as ≥1 year without menses and: i. ≥55 years, or ii. <55 years with follicle-stimulating hormone (FSH) ≥40.0 IU/L; or iii. Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation.

  4. Total Burn Surface Area (TBSA) <30% to include deep partial thickness or full thickness burn wound
  5. Burn injury requiring excision
  6. Burn injury requiring temporary allograft coverage of wound based on clinical judgement prior to definitive wound closure with autologous skin grafts
  7. Sufficient area of burn wound for Xeno-Skin™ placement, not previously treated with allograft, and not located on face or hands.

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), antiproliferative agents, and other immunomodulators
  4. Known allergy to penicillin, aminoglycosides (such as streptomycin) 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

  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 or chemical 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, endovascular procedure or surgical intervention for peripheral vascular disease or plans to undergo a major surgical or interventional procedure (e.g., 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 prior to treatment
  22. Evidence of sepsis and/or end organ damage
  23. Acute lung injury
  24. Life expectancy of less than 180 days

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
Layout table for location contacts
Contact: Paul Holzer (617) 939-7892 clinicaltrials@xenotherapeutics.org
Contact: Krysta Moulton (617) 939-7892 clinicaltrials@xenotherapeutics.org

Locations
Layout table for location information
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
Investigators
Layout table for investigator information
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.

Layout table for additonal information
Responsible Party: XenoTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03695939    
Other Study ID Numbers: 2018P001839
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: XenoTherapeutics plans to share the Individual Participant Dataset of all collected individual participant data. The following supporting information will also be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
URL: http://www.xenotherapeutics.org

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by XenoTherapeutics, Inc.:
xenograft, allograft, burns, severe burns, temporary coverage, porcine.
Additional relevant MeSH terms:
Layout table for MeSH terms
Burns
Wounds and Injuries