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Stem Cell Therapy

Cellularized Integra® for Burns (Integra®-SC Trial)

Phase 1

Waitlist Available

Led By Marc G Jeschke, MD PhD

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Total body surface area (TBSA) ≥ 5%

Full-thickness burn requiring operative procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up discharge to 1 year post-discharge

Awards & highlights

Integra®-SC Trial Summary

This trial is testing whether combining stem cells with an existing skin substitute can improve wound healing for burn patients.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is the first human trial for Integra®-SC, specific side effects are unknown but may include typical risks associated with stem cell therapies such as infection risk at the site of application and potential immune system reactions.

Integra®-SC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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At least 5% of my body is affected.

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I have a severe burn that needs surgery.

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I was admitted to the hospital within 5 days after getting burned.

Integra®-SC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ discharge to 1 year post-discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~discharge to 1 year post-discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and discharge to 1 year post-discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety - Number of participants with non-healing wounds

Safety - Number of participants with surgical site infections

Safety - Number of patients with poor scarring requiring additional (unplanned) operation

Secondary outcome measures

Cicatrization

Quality of skin regeneration - Arterial bleeding from the wound site

Quality of skin regeneration - Detachment of Integra®-SC

+6 more

Integra®-SC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Integra®-SCExperimental Treatment1 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: ControlActive Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,964 Total Patients Enrolled

3 Trials studying Burns

390 Patients Enrolled for Burns

Stem Cell NetworkOTHER

8 Previous Clinical Trials

566 Total Patients Enrolled

Ontario Institute for Regenerative MedicineUNKNOWN

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Integra®-SC (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05344521 — Phase 1

Burns Research Study Groups: Control, Integra®-SC

Burns Clinical Trial 2023: Integra®-SC Highlights & Side Effects. Trial Name: NCT05344521 — Phase 1

Integra®-SC (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05344521 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to enroll in this research study?

"According to clinicaltrials.gov, this investigation is no longer inviting patients; it was first publicized on May 1st 2022 and recently revised on April 21st 2022. Nevertheless, there are 73 other medical trials actively enrolling participants at present."

Answered by AI

Has Integra®-SC been granted clearance by the FDA?

"With limited data regarding efficacy and safety, Integra®-SC is evaluated as a 1 on our scale from 1 to 3. This study has been classified as Phase 1."

Answered by AI

What objectives has this research initiative been designed to accomplish?

"This trial aims to assess the safety of participants with non-healing wounds over a period ranging from 1 to 4 months post hospitalization. Secondary outcomes include evaluating scar formation, signs of wound infection, and arterial bleeding based on photography taken at various points during treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells

Marc Jeschke 2024. "A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05344521.