Clinical trial NCT05344521: A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells
Official title: A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Burns
Keywords: Stem Cells
Wound Healing
Cicatrix
Skin, Artificial
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: AFP Innovation Fund
name: Ontario Institute for Regenerative Medicine
name: Stem Cell Network
First posted: 2022-04-25
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety - Number of participants with surgical site infections
timeFrame: Acute hospitalization (1-4 months post admission depending on severity of injury)
measure: Safety - Number of participants with non-healing wounds
timeFrame: Acute hospitalization (1-4 months post admission depending on severity of injury)
measure: Safety - Number of patients with poor scarring requiring additional (unplanned) operation
timeFrame: Discharge to to 1 year post-discharge
Secondary outcomes:
measure: Time of wound healing
timeFrame: Acute hospitalization (1-4 months post admission depending on severity of injury)
measure: Quality of skin regeneration - Arterial bleeding from the wound site
timeFrame: Acute hospitalization (1-4 months post admission depending on severity of injury)
measure: Quality of skin regeneration - Signs of wound infection
timeFrame: Acute hospitalization (1-4 months post admission depending on severity of injury)
measure: Quality of skin regeneration - Detachment of Integra®-SC
timeFrame: Acute hospitalization (1-4 months post admission depending on severity of injury)
measure: Quality of skin regeneration - Abnormal scar formation
timeFrame: Acute hospitalization (1-4 months post admission depending on severity of injury)
measure: Scar Formation - Vascularity of the healed area
timeFrame: Discharge to 1 year post-discharge
measure: Scar formation - Pigmentation of the healed area
timeFrame: Discharge to 1 year post-discharge
measure: Scar formation - Pliability of the healed area
timeFrame: Discharge to 1 year post-discharge
measure: Scar formation - Height of the healed area
timeFrame: Discharge to 1 year post-discharge
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Marc G Jeschke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: