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

NCT05344521 | Not Yet Recruiting Phase 1 DMC FDA Device

• 1 other identifier: 15229
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Stem Cells; Wound Healing; Cicatrix; Skin, Artificial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Time of wound healing

  Acute hospitalization (1-4 months post admission depending on severity of injury)

• Quality of skin regeneration - Arterial bleeding from the wound site

  Acute hospitalization (1-4 months post admission depending on severity of injury)

• Quality of skin regeneration - Signs of wound infection

  Acute hospitalization (1-4 months post admission depending on severity of injury)

• Quality of skin regeneration - Detachment of Integra®-SC

  Acute hospitalization (1-4 months post admission depending on severity of injury)

• Quality of skin regeneration - Abnormal scar formation

  Acute hospitalization (1-4 months post admission depending on severity of injury)

Study Arms (2)

Control

ACTIVE COMPARATOR

After removal of the temporary wound coverage (allograft), Integra® is applied directly onto the wound surface.

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.

Device: Integra®-SC

Interventions

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).

Control

Integra®-SC DEVICE

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

Integra®-SC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• AFP Innovation Fund: collaborator
• Ontario Institute for Regenerative Medicine: collaborator
• Stem Cell Network: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Burns; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc G Jeschke, MD PhD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc G Jeschke, MD PhD

CONTACT

905-521-2100; marc.jeschke@hhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study where the participant will not know which area is covered with Integra®-SC.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Research, Medical Director Burn Unit

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 25, 2022
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

CA (1)