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

NCT ID: NCT05344521

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Burns

Keywords

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Stem Cells Wound Healing Cicatrix Skin, Artificial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
This is a single-blind study where the participant will not know which area is covered with Integra®-SC.

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Integra®

Intervention Type 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®-SC

After removal of the temporary wound coverage (allograft), Integra®-SC is applied to the contralateral area of the site where Integra® is applied.

Group Type EXPERIMENTAL

Integra®-SC

Intervention Type DEVICE

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

Interventions

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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).

Intervention Type DEVICE

Integra®-SC

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

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AFP Innovation Fund

OTHER

Sponsor Role collaborator

Ontario Institute for Regenerative Medicine

UNKNOWN

Sponsor Role collaborator

Stem Cell Network

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Marc Jeschke

Vice President of Research, Medical Director Burn Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc G Jeschke, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

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Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Marc G Jeschke, MD PhD

Role: CONTACT

Phone: 905-521-2100

Email: [email protected]

Facility Contacts

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Marc G Jeschke, MD PhD

Role: primary

Other Identifiers

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15229

Identifier Type: -

Identifier Source: org_study_id