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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burns
• Intervention / Treatment: Device: Integra®; Device: Integra®-SC

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Marc G Jeschke, MD PhD; Phone Number: 40694 905-521-2100; Email: marc.jeschke@hhsc.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
      • Principal Investigator: Marc G Jeschke, MD PhD
      • Contact: Marc G Jeschke, MD PhD; Phone Number: 40694 905-521-2100; Email: marc.jeschke@hhsc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; After removal of the temporary wound coverage (allograft), Integra® is applied directly onto the wound surface.	Device: Integra®; 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).
Experimental: Integra®-SC; After removal of the temporary wound coverage (allograft), Integra®-SC is applied to the contralateral area of the site where Integra® is applied.	Device: Integra®-SC; A combination of Integra® incorporated with 5,000-20,000 cells/cm2 of autologous burned derived stem cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Number of participants with surgical site infections	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.	Acute hospitalization (1-4 months post admission depending on severity of injury)
Safety - Number of participants with non-healing wounds	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.	Acute hospitalization (1-4 months post admission depending on severity of injury)
Safety - Number of patients with poor scarring requiring additional (unplanned) operation	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.	Discharge to to 1 year post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of wound healing	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.	Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Arterial bleeding from the wound site	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.	Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Signs of wound infection	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.	Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Detachment of Integra®-SC	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.	Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Abnormal scar formation	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.	Acute hospitalization (1-4 months post admission depending on severity of injury)
Scar Formation - Vascularity of the healed area	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.	Discharge to 1 year post-discharge
Scar formation - Pigmentation of the healed area	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.	Discharge to 1 year post-discharge
Scar formation - Pliability of the healed area	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.	Discharge to 1 year post-discharge
Scar formation - Height of the healed area	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.	Discharge to 1 year post-discharge

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: AFP Innovation Fund; Stem Cell Network; Ontario Institute for Regenerative Medicine
• Investigators: Principal Investigator: Marc G Jeschke, MD PhD, Hamilton Health Sciences Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Wound Healing; Stem Cells; Cicatrix; Skin, Artificial
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 15229

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes