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NCT Number: NCT05344521

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

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.

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Key information

Conditions

Burns Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location contact

Marc G Jeschke, MD PhD

CONTACT

[email protected]

905-521-2100 ext. 40694

Marc G Jeschke, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 18 years.
  • Total body surface area (TBSA) ≥ 5%.
  • Full-thickness burn requiring operative procedures.
  • Admitted ≤ 120 hours following burn.
  • Injury location includes a contralateral area.

Exclusion criteria

All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:

  • Patients who are moribund.
  • Known infection with any of the following: Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, Human T-lymphotropic Virus (HTLV), Syphilis, or West Nile Virus.
  • Injury location limited to face and/or hands.
  • Pregnancy.
  • Active cancer and currently undergoing treatment.

Treatment and study plan

INTEGRA®

Device

A commercially available dermal bovine matrix that is widely used for wound and burn care, Integra® Dermal Regeneration Template licensed device (Medical Device Active License Listing No. 229).

Integra®-SC

Device

A combination of Integra® incorporated with 5,000-20,000 cells/cm2 of autologous burned derived stem cells.

Primary outcomes

  1. Safety - Number of participants with surgical site infections

    Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)

    The primary outcome of this study is safety. In order to assess the safety of Integra®-SC, surgical site infections that require an additional (unplanned) operation will be recorded as an in-hospital complication.

  2. Safety - Number of participants with non-healing wounds

    Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)

    The primary outcome of this study is safety. In order to assess the safety of Integra®-SC, non-healing wounds that require an additional (unplanned) operation will be recorded as an in-hospital complication.

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

    Time frame: Discharge to to 1 year post-discharge

    The primary outcome of this study is safety. In order to assess the safety of Integra®-SC, poor scarring requiring an additional (unplanned) operation will be recorded as a late-onset complication.

Secondary outcomes

  1. Time of wound healing

    Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)

    Time from wound excision to 95% healing of the burned area will be recorded. Photography and evaluation of wounds will occur at enrollment, operation days, dressing take-downs, and discharge from hospital.

  2. Quality of skin regeneration - Arterial bleeding from the wound site

    Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)

    Arterial bleeding from the wound site will be recorded to assess the quality of skin regeneration. Photography and evaluation of wounds will occur at enrollment, operation days, dressing take-downs, and discharge from hospital.

  3. Quality of skin regeneration - Signs of wound infection

    Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)

    Classic signs of wound infection will be recorded to assess the quality of skin regeneration. Photography and evaluation of wounds will occur at enrollment, operation days, dressing take-downs, and discharge from hospital.

  4. Quality of skin regeneration - Detachment of Integra®-SC

    Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)

    The detachment of the entire Integra®-SC from the wound site will be recorded to assess the quality of skin regeneration. Photography and evaluation of wounds will occur at enrollment, operation days, dressing take-downs, and discharge from hospital.

  5. Quality of skin regeneration - Abnormal scar formation

    Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)

    The formation of hypertrophic scars or keloids will be recorded to assess the quality of skin regeneration. Photography and evaluation of wounds will occur at enrollment, operation days, dressing take-downs, and discharge from hospital.

  6. Scar Formation - Vascularity of the healed area

    Time frame: Discharge to 1 year post-discharge

    Vascularity of the healed area is assessed as part of the Vancouver Scar Scale to evaluate scar formation over time. Vascularity is scored from 0 to 3, with higher scores indicating worse outcomes. Photography and evaluation of treated area for scar formation will be assessed at outpatient follow-ups at approximately 30 days, 60 days, 90 days, 180 days, and 365 days post-discharge (with 2-4 weeks deviation). Follow-ups typically take place in-person at clinic visits, but may take place online via a secure platform.

  7. Scar formation - Pigmentation of the healed area

    Time frame: Discharge to 1 year post-discharge

    Pigmentation of the healed area is assessed as part of the Vancouver Scar Scale to evaluate scar formation over time. Pigmentation is scored from 0 to 2, with higher scores indicating worse outcomes. Photography and evaluation of treated area for scar formation will be assessed at outpatient follow-ups at approximately 30 days, 60 days, 90 days, 180 days, and 365 days post-discharge (with 2-4 weeks deviation). Follow-ups typically take place in-person at clinic visits, but may take place online via a secure platform.

  8. Scar formation - Pliability of the healed area

    Time frame: Discharge to 1 year post-discharge

    Pliability of the healed area is assessed as part of the Vancouver Scar Scale to evaluate scar formation over time. Pliability is scored from 0 to 5, with higher scores indicating worse outcomes. Photography and evaluation of treated area for scar formation will be assessed at outpatient follow-ups at approximately 30 days, 60 days, 90 days, 180 days, and 365 days post-discharge (with 2-4 weeks deviation). Follow-ups typically take place in-person at clinic visits, but may take place online via a secure platform.

  9. Scar formation - Height of the healed area

    Time frame: Discharge to 1 year post-discharge

    The height of the healed area is assessed as part of the Vancouver Scar Scale to evaluate scar formation over time. Height is scored from 0 to 3, with higher scores indicating worse outcomes. Photography and evaluation of treated area for scar formation will be assessed at outpatient follow-ups at approximately 30 days, 60 days, 90 days, 180 days, and 365 days post-discharge (with 2-4 weeks deviation). Follow-ups typically take place in-person at clinic visits, but may take place online via a secure platform.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc G Jeschke, MD PhD

CONTACT

[email protected]

905-521-2100 ext. 40694

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • AFP Innovation Fund
  • Ontario Institute for Regenerative Medicine
  • Stem Cell Network

Registry information

Acronym: Integra®-SC

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 25, 2022
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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