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Trial record 1 of 1 for:    XenoTherapeutics
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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.

Tracking Information
First Submitted Date  ICMJE September 28, 2018
First Posted Date  ICMJE October 4, 2018
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE March 15, 2019
Estimated Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • 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
  • 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.
  • Time of Graft Adherence. [ Time Frame: daily through 4 weeks ]
    To assess the duration of temporary barrier function afforded by Xeno-Skin™
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • 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
  • 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, Scale 0-5 for 6 independent parameters for wound assessment Branski et al 2011)
  • Time of Graft Adherence. [ Time Frame: daily through 4 weeks ]
    To assess the duration of temporary barrier function afforded by Xeno-Skin™
Change History Complete list of historical versions of study NCT03695939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety of Xeno-Skin™ for Treatment of Severe and Extensive, Partial and Full Thickness Burns
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burn Wound
Intervention  ICMJE Biological: Xeno-Skin™
3+3 Dose-escalation Study Design; 2 dosage strengths will be utilized during this Phase 1 Trial
Study Arms  ICMJE Experimental: Xeno-Skin™
Single arm trial
Intervention: Biological: Xeno-Skin™
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2020
Estimated Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paul Holzer (617) 939-7892 clinicaltrials@xenotherapeutics.org
Contact: Krysta Moulton (617) 939-7892 clinicaltrials@xenotherapeutics.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03695939
Other Study ID Numbers  ICMJE 2018P001839
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
URL: http://www.xenotherapeutics.org
Responsible Party XenoTherapeutics, Inc.
Study Sponsor  ICMJE XenoTherapeutics, Inc.
Collaborators  ICMJE Massachusetts General Hospital
Investigators  ICMJE
Principal Investigator: Jeremy Goverman, MD Massachusetts General Hospital
PRS Account XenoTherapeutics, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP