Integra®-SC: The Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Safety - Number of participants with surgical site infections [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.
- Safety - Number of participants with non-healing wounds [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.
- Safety - Number of patients with poor scarring requiring additional (unplanned) operation [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 Outcome Measures
- Time of wound healing [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.
- Quality of skin regeneration - Arterial bleeding from the wound site [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.
- Quality of skin regeneration - Signs of wound infection [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.
- Quality of skin regeneration - Detachment of Integra®-SC [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.
- Quality of skin regeneration - Abnormal scar formation [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.
- Scar Formation - Vascularity of the healed area [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.
- Scar formation - Pigmentation of the healed area [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.
- Scar formation - Pliability of the healed area [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.
- Scar formation - Height of the healed area [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged ≥ 18 years.
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Total body surface area (TBSA) ≥ 5%.
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Full-thickness burn requiring operative procedures.
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Admitted ≤ 120 hours following burn.
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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:
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Patients who are moribund.
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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.
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Injury location limited to face and/or hands.
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Pregnancy.
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Active cancer and currently undergoing treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
- AFP Innovation Fund
- Ontario Institute for Regenerative Medicine
Investigators
- Principal Investigator: Marc G Jeschke, MD PhD, Sunnybrook Health Sciences Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 142-2015