realSKIN® for Burns

Recruiting at 4 trial locations

Overseen By Kaitlyn Rogers, PhD(C)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: XenoTherapeutics, Inc.

Must not be taking: Immunosuppressants, Experimental drugs

Disqualifiers: Pregnancy, HIV, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate the safety and efficacy of realSKIN® to provide complete wound closure of mixed-depth, full-thickness burn wounds as an alternative treatment to autografting.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are on immunosuppressive medications or have used experimental drugs within 30 days before the trial.

What data supports the effectiveness of the treatment realSKIN® for Burns?

Research indicates that bioengineered skin substitutes, like realSKIN®, are effective in managing burns by providing a temporary cover that helps heal the wound. These substitutes are part of evolving treatments that improve survival rates in burn patients by enhancing wound care techniques. ^{1 2 3 4 5}

Is realSKIN® safe for use in humans?

There is no specific safety data available for realSKIN® or similar treatments like Autografting in the provided research articles. ^{6 7 8 9 10}

What makes the treatment realSKIN® unique for treating burns?

realSKIN® is a novel treatment for burns that likely involves advanced skin substitute technology, aiming to replicate the natural skin's protective barrier and promote healing. Unlike traditional methods, it may incorporate biocompatible and biodegradable materials to support both the epidermis and dermis, potentially offering improved outcomes for severe burn patients. ^{1 11 12 13 14}

Research Team

Bounthavy Homsombath, MD

Principal Investigator

JMS BURN CENTER AT DOCTORS HOSPITAL OF AUGUSTA

Eligibility Criteria

This trial is for individuals with mixed-depth, full-thickness burn wounds. It's designed to see if realSKIN® can help heal these burns as an alternative to the standard treatment of autografting, where a patient's own skin is used.

Inclusion Criteria

My burn wound is not on my face, hands, joints, feet soles, or groin area.

Less than half of my body has severe burns needing surgery.

All subjects must agree to use a protocol-approved method of contraception for a minimum of 3 months following realSKIN placement, which includes a barrier method plus one or more of the following: Hormonal contraceptives, Intrauterine device (IUD), Male or female condoms with spermicide, Diaphragm with spermicide, Permanent tubal occlusive birth control system

Exclusion Criteria

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)

Documented evidence of wound infection at Screening

My latest HbA1c level is 10% or higher.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Preparation

Surgical excision to remove nonviable tissue or previously applied temporary wound dressings

1 week

1 visit (in-person)

Treatment

Participants receive approximately 100 square centimeters of realSKIN at a predesignated wound site and autografting at an alternate site

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for complete wound closure and residual porcine cell populations

4 months

Monthly visits (in-person)

Treatment Details

Interventions

• Autograft(ing)
• realSKIN®

Trial Overview The study tests the safety and effectiveness of realSKIN®, a new potential treatment for serious burns, against autografting. Participants will be assigned to receive either realSKIN® or undergo traditional autograft surgery.

Participant Groups

Group I: Skin Xenotransplant Experimental Treatment 1 Intervention

After surgical preparation of the wound beds, subjects will receive approximately 100 square centimeters of realSKIN® at one site, and autograft at the other site, per the standard of care, in accordance with the randomization schedule.

Group II: Autograft Active Control 1 Intervention

The comparator control for the study is autografting: the current standard of care procedure for the treatment of severe burns involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound to achieve complete and durable wound closure.

Who Is Running the Clinical Trial?

XenoTherapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

80+

Joseph M. Still Research Foundation, Inc.

Collaborator

Trials

9

Recruited

360+

Findings from Research

From 2004 to 2016, only 166 adverse events related to baby personal care products were reported to the FDA, with most cases involving skin reactions like rashes, and nearly half of these incidents required a healthcare visit.

The study highlights the need for pediatric dermatologists to actively report adverse events and encourage consumers to do the same, as current reporting is low and may not fully capture the safety concerns associated with these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants. Cornell, E., Kwa, M., Paller, AS., et al.[2018]

Over a 38-month period, drug therapy was linked to an average of 243 reported deaths annually in infants and young children under 2 years old, with a significant number occurring in the first month and year of life.

A substantial portion of adverse events (24%) were associated with drug exposure from the mother during pregnancy, delivery, or lactation, highlighting the need for careful consideration of medication risks during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reported adverse drug events in infants and children under 2 years of age. Moore, TJ., Weiss, SR., Kaplan, S., et al.[2022]

Between 2004 and 2017, 41% of all adverse events related to cosmetics reported to the FDA were cancer-related, totaling 4427 reports, with a significant number linked to ovarian cancer and talc powders.

The current data from the FDA's adverse event reporting system is limited due to high rates of redaction and potential reporter bias, indicating a need for improved reporting practices and regulatory science to better assess the safety of cosmetic products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cosmetics and Cancer: Adverse Event Reports Submitted to the Food and Drug Administration. Jacob, SL., Cornell, E., Kwa, M., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Commercialization of skin substitutes for third-degree burn wounds. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Bioengineered skin substitutes for the management of burns: a systematic review. [2018]

3. England pubmed.ncbi.nlm.nih.gov

A guide to biological skin substitutes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Improving survival in the burned patient. [2006]

5. Israel pubmed.ncbi.nlm.nih.gov

Skin substitutes. [2006]

6. England pubmed.ncbi.nlm.nih.gov

Skin safety evaluation of laundry detergent products. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Pre-validation of an in vitro skin irritation test for medical devices using the reconstructed human tissue model EpiDerm™. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Reported adverse drug events in infants and children under 2 years of age. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Cosmetics and Cancer: Adverse Event Reports Submitted to the Food and Drug Administration. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Integra artificial skin in use for full-thickness burn surgery: benefits or harms on patient outcome. [2005]

12. Iran pubmed.ncbi.nlm.nih.gov

In vitro co-culture of human skin keratinocytes and fibroblasts on a biocompatible and biodegradable scaffold. [2022]

13. France pubmed.ncbi.nlm.nih.gov

[Skin substitutes and skin culture]. [2006]

14. England pubmed.ncbi.nlm.nih.gov

Skin tissue engineering advances in severe burns: review and therapeutic applications. [2022]