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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called realSKIN® to determine its effectiveness in healing severe burn wounds. Instead of using skin from another part of the patient's body (autografting), realSKIN® is applied directly to the burn to promote healing. The trial aims to assess whether realSKIN® is as safe and effective as the traditional method. Individuals with deep burn wounds requiring skin grafting, excluding those on the face or hands, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that realSKIN®, a treatment for burn wounds, has undergone safety testing in earlier studies. In one study, 22 patients with various types of burn wounds received realSKIN®. The results showed that the treatment was well-tolerated, with no serious side effects directly linked to it. Additionally, some patients did not require further procedures, such as using their own skin to cover wounds.

These findings suggest that realSKIN® is safe for use in humans, as previous studies have not reported major safety issues. This information can reassure those considering joining a trial that earlier research has checked the treatment for safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard burn treatment of autografting, which involves taking healthy skin from another part of the patient's body, realSKIN® offers a different approach. This treatment uses a skin xenotransplant, meaning it involves transplanting skin from a non-human source, which could potentially reduce the need for additional surgeries and donor site wounds. Researchers are excited about realSKIN® because it aims to simplify the healing process and lessen the burden on patients by providing an alternative that doesn't rely solely on their own skin for recovery.

What evidence suggests that realSKIN® is effective for burn wound closure?

This trial will compare realSKIN® with autografting for treating severe burns. Research has shown that realSKIN®, which uses genetically modified pig skin, can effectively heal severe burn wounds. Specifically, previous patients demonstrated that this treatment can completely and permanently close wounds. Clinical data indicate that realSKIN® serves as a strong alternative to traditional methods like autografting, where a patient's own skin is used. These findings suggest that realSKIN® could effectively provide extensive skin coverage for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Bounthavy Homsombath, MD

Principal Investigator

JMS BURN CENTER AT DOCTORS HOSPITAL OF AUGUSTA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03695939

Evaluation of Safety and Efficacy of realSKIN® (Skin ... This is a Phase 1/2, Open-label, Multi-center, Clinical Trial to evaluate the safety, tolerability, and efficacy of realSKIN® to provide complete wound ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10652578/

The clinical outcomes of xenografts in the treatment of burn ... Although autografts showed promising results in treating burns, patients with extensive burns require temporary coverages with allografts, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06223269

Safety and Efficacy of realSKIN® to Provide Complete ... 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 ...

4. academic.oup.com academic.oup.com/jbcr/article/45/Supplement_1/263/7648928

Complete Wound Closure of Mixed-Depth Burns via Porcine ... These clinical data demonstrate the ability of a live, genetically altered skin xenotransplant to facilitate complete and durable wound closure ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417918301529

Skin xenotransplantation: Historical review and clinical ... We summarize the current status of research into skin xenotransplantation for burns, with special emphasis on developments in genetic engineering of pigs.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11023421/

Complete Wound Closure of Mixed-Depth Burns via ... 22 patients with mixed-depth burn wounds were enrolled in Phase 1/2/2b US-FDA clinical trials to evaluate the safety and efficacy of skin ...

7. academic.oup.com academic.oup.com/jbcr/article-pdf/45/Supplement_1/263/57260343/irae036.345.pdf

Abstract citation ID: irae036.344 804 First-in-Human ... In 3 cases, mixed-depth burns treated with the skin xenotransplant did not require autografting. Conclusions: These clinical data demonstrate ...