BurnsPhase 1Integra®-SCNCT05344521
A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells
A Phase 1 study testing Integra® and Integra®-SC in people with Burns, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Integra® and Integra®-SC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2024to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Marc G Jeschke, MD PhD, 905-521-2100 ext. 40694, marc.jeschke@hhsc.ca
Marc G Jeschke, MD PhD
About this study
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.
- Conditions
- Burns
- Being tested
- Integra®, Integra®-SC
- Keywords
- Stem Cells, Wound Healing, Cicatrix, Skin, Artificial
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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®-SCDevice
A combination of Integra® incorporated with 5,000-20,000 cells/cm2 of autologous burned derived stem cells.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | After removal of the temporary wound coverage (allograft), Integra® is applied directly onto the wound surface. Receives: Device: Integra® |
| Integra®-SC | Experimental | After removal of the temporary wound coverage (allograft), Integra®-SC is applied to the contralateral area of the site where Integra® is applied. Receives: Device: Integra®-SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Discharge to to 1 year post-discharge
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Discharge to 1 year post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study startFeb 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Integra®-SC will be applied to one area of the body and acellular Integra® will be applied to another. Determination of the location of the Integra® control or Integra®-SC application will be assigned using simple randomization. The wound areas will be appropriately matched for body surface area and depth of the wound.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- AFP Innovation Fund, Ontario Institute for Regenerative Medicine, Stem Cell Network
- Responsible party
- Principal investigator, Marc Jeschke, Hamilton Health Sciences Corporation
- Investigators
- Marc G Jeschke, MD PhD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344521
- Sponsor's protocol ID
- 15229
- Acronym
- Integra®-SC
- Status last verified
- Dec 2023
- First submitted
- 24 Mar 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells
- ClinicalTrials.gov ID
- NCT05344521
- Acronym / sponsor ID
- Integra®-SC / 15229
- Conditions
- Burns
- Keywords
- Stem Cells, Wound Healing, Cicatrix, Skin, Artificial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- AFP Innovation Fund, Ontario Institute for Regenerative Medicine, Stem Cell Network
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Integra®-SC will be applied to one area of the body and acellular Integra® will be applied to another. Determination of the location of the Integra® control or Integra®-SC application will be assigned using simple randomization. The wound areas will be appropriately matched for body surface area and depth of the wound.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Integra®After removal of the temporary wound coverage (allograft), Integra® is applied directly onto the wound surface. |
| Integra®-SC | Experimental | Device: Integra®-SCAfter removal of the temporary wound coverage (allograft), Integra®-SC is applied to the contralateral area of the site where Integra® is applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Control |
| Integra®-SCA combination of Integra® incorporated with 5,000-20,000 cells/cm2 of autologous burned derived stem cells. | Device | Integra®-SC |
Primary outcome
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.
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.
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.
9 secondary outcomes
Time of wound healing
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Arterial bleeding from the wound site
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Signs of wound infection
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Detachment of Integra®-SC
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Quality of skin regeneration - Abnormal scar formation
Time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)
Scar Formation - Vascularity of the healed area
Time frame: Discharge to 1 year post-discharge
Scar formation - Pigmentation of the healed area
Time frame: Discharge to 1 year post-discharge
Scar formation - Pliability of the healed area
Time frame: Discharge to 1 year post-discharge
Scar formation - Height of the healed area
Time frame: Discharge to 1 year post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc G Jeschke, MD PhD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Integra® and Integra®-SC in people with Burns, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc G Jeschke, MD PhD (905-521-2100 ext. 40694, marc.jeschke@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Number of participants with surgical site infections (time frame: Acute hospitalization (1-4 months post admission depending on severity of injury)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.