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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

April 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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™

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

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

Phase 1

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Biological: Xeno-Skin™
3+3 Dose-escalation Study Design; 2 dosage strengths will be utilized during this Phase 1 Trial

Study Arms

Experimental: Xeno-Skin™
Single arm trial

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2019

Estimated Primary Completion Date

April 2019 (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

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

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

Plan to Share IPD:

Yes

Responsible Party

，

Study Sponsor ^ICMJE

XenoTherapeutics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Jeremy Goverman, MD Massachusetts General Hospital
Study Director: Curtis Cetrulo, MD Massachusetts General Hospital
Study Chair: Jay Fishman, MD Massachusetts General Hospital

PRS Account

Verification Date

October 2018

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

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