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.
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 31, 2021
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.
- Biological: Xeno-Skin™
- 3+3 Dose-escalation Study Design; 2 dosage strengths will be utilized during this Phase 1 Trial
Arms, Groups and Cohorts
- Experimental: Xeno-Skin™
- Single arm trial
Clinical Trial Outcome Measures
- 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™
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- XenoTherapeutics, Inc.
- Massachusetts General Hospital
- Provider of Information About this Clinical Study
- Overall Official(s)
- Jeremy Goverman, MD, Principal Investigator, Massachusetts General Hospital
- Overall Contact(s)
- Paul Holzer, (617) 939-7892, email@example.com
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