Cellularized Integra® for Burns

(Integra®-SC Trial)

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

29 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Integra®-SC for burns?

Integra, an artificial skin, has been shown to decrease the length of hospital stay for severely injured burn patients, especially those with multiple risk factors. It also provides protection against fluid loss and bacterial invasion, leading to functionally and aesthetically acceptable scar formation. ^{1 2 3 4 5}

Is Cellularized Integra® safe for use in humans?

Integra, an artificial skin substitute, has been used in treating burns and has shown to be generally safe, though infections are a common complication. In a study, 42% of patients experienced infections, often involving bacteria like Pseudomonas aeruginosa and Staphylococcus aureus, suggesting that careful application and monitoring are important to reduce infection risks. ^{2 4 5 6 7}

How does the treatment Integra®-SC differ from other treatments for burns?

Integra®-SC is unique because it is an artificial skin substitute that provides immediate full-thickness reconstruction for burns, using a collagen/glycosaminoglycane matrix and a silicon layer to protect tissue and promote the formation of a new dermis. This approach is particularly beneficial for massive burns where donor skin is limited, offering superior functional and cosmetic outcomes compared to traditional methods. ^{2 3 4 5 8}

What is the purpose of this trial?

Burn injuries are one of the most severe skin injuries and lead to a complex wound healing response. When the skin is wounded, stem cells in the skin must respond fast to help repair the injured tissue. The damaged skin of burn patients contains cells that are still alive and have typical stem cell characteristics. Because stem cells are so important for wound healing, the investigators have combined them with an existing skin substitute, Integra®, to examine the potential wound healing benefits of these stem cells. This is an investigational treatment and a first in-human trial. The purpose of this study is to test the safety of using a patient's own stem cells combined with Integra®, which the investigators call Integra®-Stem Cells (Integra®-SC). The investigators hypothesize that Integra®-SC will result in improved wound healing, better scar quality, and decreased scar formation at one-year post-injury.

Research Team

Marc G Jeschke, MD PhD

Principal Investigator

Hamilton Health Sciences Corporation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Correlation of clinical outcome of integra application with microbiologic and pathological biopsies. [2018]

2. France pubmed.ncbi.nlm.nih.gov

[Incidence and microbiology of infectious complications with the use of artificial skin Integra in burns]. [2022]

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

Use of Integra artificial skin is associated with decreased length of stay for severely injured adult burn survivors. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Administration of Integra on primary burn wounds and unstable secondary scars]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The use of a bilaminate artificial skin substitute (Integra) in acute resurfacing of burns: an early experience. [2005]

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

Longitudinal assessment of Integra in primary burn management: a randomized pediatric clinical trial. [2007]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Functional results of burned hands treated with Integra®. [2022]

8. Netherlands 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. [2018]