Cellularized Integra® for Burns

(Integra®-SC Trial)

Not yet recruiting at 1 trial location

Overseen By Marc G Jeschke, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hamilton Health Sciences Corporation

Disqualifiers: HIV, Hepatitis B, Pregnancy, others

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

Compensation: Varies

Number of Visits: 30

Duration: 1-4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for severe burn injuries. Researchers combine a patient's own stem cells with a skin substitute called Integra® to determine if it improves healing and reduces scarring. The trial aims to assess the safety and effectiveness of this combination, known as Integra®-SC. Suitable participants have burns covering at least 5% of their body and require surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Integra®-SC is likely to be safe for humans?

Research shows that treatments using cells, such as Integra®-SC, could aid in healing burn wounds. In studies, these treatments have shown promising results.

However, Integra®-SC is a new treatment and is undergoing its first tests in humans. Researchers are still determining its safety for human use. The primary goal of this initial trial is to assess its safety.

Although the treatment is in early testing, its study indicates hope for its potential. However, it is important to understand that safety information is still being collected. Considering participation in this trial offers an opportunity to contribute to important research and help doctors learn more about the treatment's safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Integra®-SC for treating burns because it represents an innovative approach to wound healing. Unlike traditional treatments that primarily focus on skin grafts, Integra®-SC is a cellularized version of Integra®, which means it incorporates living cells into its structure. This cellular component could potentially enhance the healing process by promoting better integration with the patient's tissue and reducing healing time. Additionally, by applying Integra®-SC to areas opposite where standard Integra® is used, researchers can directly compare its effectiveness, offering insights that could lead to faster recovery and improved outcomes for burn patients.

What evidence suggests that Integra®-SC might be an effective treatment for burns?

Research has shown that cell-based treatments for burn wounds are very promising. Studies have found that combining stem cells with skin substitutes like Integra® can enhance wound healing and improve scar quality. Previous research demonstrated faster healing and less scarring with these treatments compared to traditional methods. In this trial, participants will receive either Integra®-SC, which combines a patient's own stem cells with Integra®, or the control treatment where Integra® is applied without stem cells. Integra®-SC aims to boost benefits by utilizing the body’s natural healing cells. Although this is the first study of its kind in humans, early results suggest that stem cells can improve the healing process in burn patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Marc G Jeschke, MD PhD

Principal Investigator

Hamilton Health Sciences Corporation

Are You a Good Fit for This Trial?

Adults with burns covering at least 5% of their body, needing surgery, and admitted within 120 hours after the burn can join. The trial is not for those with active cancer treatments, severe health conditions, certain infections (HIV, Hepatitis B/C, HTLV, Syphilis or West Nile Virus), burns only on face/hands or if pregnant.

Inclusion Criteria

Injury location includes a contralateral area

At least 5% of my body is affected.

I have a severe burn that needs surgery.

Exclusion Criteria

Pregnancy

Patients who are moribund

I do not have infections like HIV, Hepatitis B/C, HTLV, Syphilis, or West Nile Virus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Integra® or Integra®-SC applied to the wound surface after removal of temporary wound coverage

1-4 months

Multiple visits during acute hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including scar formation and wound healing

1 year post-discharge

Follow-ups at approximately 30, 60, 90, 180, and 365 days post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Integra®-SC

Trial Overview This study tests a new treatment combining a patient's own stem cells with Integra®, a skin substitute. Named Integra®-SC, it aims to improve wound healing and reduce scarring in burn patients. It's the first time this method is being tried on humans.

How Is the Trial Designed?

Group I: Integra®-SC Experimental Treatment 1 Intervention

After removal of the temporary wound coverage (allograft), Integra®-SC is applied to the contralateral area of the site where Integra® is applied.

Group II: Control Active Control 1 Intervention

After removal of the temporary wound coverage (allograft), Integra® is applied directly onto the wound surface.

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Stem Cell Network

Collaborator

Trials

9

Recruited

600+

Ontario Institute for Regenerative Medicine

Collaborator

Trials

2

Recruited

60+

AFP Innovation Fund

Collaborator

Trials

9

Recruited

1,500+

Published Research Related to This Trial

Integra, an artificial skin substitute, has been increasingly used in Germany for treating extensive full-thickness burns and posttraumatic reconstruction, highlighting its evolving role in burn therapy over the past 6 years.

The study emphasizes the importance of skilled surgical handling of Integra to ensure its effectiveness as a reconstructive dermal substitute for severely burned or posttraumatic patients, and aims to provide guidelines for its proper use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the use of collagen/glycosaminoglycate skin substitute-six years of experiences with artificial skin in 15 German burn centers. Heitland, A., Piatkowski, A., Noah, EM., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05344521

Study Details | NCT05344521 | A Phase I, Single-blind, ... The investigators hypothesize that Integra®-SC will result in improved wound healing, better scar quality, and decreased scar formation at one-year post-injury.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11373270/

Advancements in cell-based therapies for thermal burn ... Our study showed that employing cell-based therapies for the treatment of burn wounds have significant results in clinical studies and are promising approaches.

3. withpower.com withpower.com/trial/phase-1-burns-4-2022-fcb96

Cellularized Integra® for Burns · Info for Participants What data supports the effectiveness of the treatment Integra®-SC for burns? ... effectiveness after treatment, including scar formation and wound healing.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022480424000131

Current Approaches to Wound Repair in Burns: How far ... In superficial burn wounds or split-thickness donor sites, FSGs have been found to accelerate wound healing, reduce pain, reduce the need for dressing changes, ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/p900033s042b.pdf

Summary of Safety and Effectiveness Data - accessdata.fda.gov This 19.3% treatment difference was statistically significant (p-value = 0.0007). Secondary Effectiveness Outcomes. Complete Wound Closure – ...