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

Burns Clinical Trial

— Integra®-SC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05344521
• Other study ID #: 15229
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 2024
• Est. completion date: February 2027

Study information

• Verified date: December 2023
• Source: Hamilton Health Sciences Corporation
• Contact: Marc G Jeschke, MD PhD
• Phone: 905-521-2100
• Email: marc.jeschke[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 29
• Est. completion date: February 2027
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

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

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	AFP Innovation Fund, Ontario Institute for Regenerative Medicine, Stem Cell Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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