StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )

NCT04123548 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: MNK01053115
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 10

Brief Summary

An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body. StrataGraft skin tissue was an investigational tissue that could be used as an alternative to an autograft.

• StrataGraft skin tissue was in late-stage clinical development for the treatment of adults with deep partial-thickness (DPT) burns.
• There were no safety concerns reported to date. The sponsor submitted a treatment protocol to Food and Drug Administration (FDA) for doctors who participated in the Phase 3 Strata 2016 study (NCT 03005106) to allow for expanded access to StrataGraft before it was commercially available. The main purpose of the study was to allow patients to receive StrataGraft during Biologics License Application review and prior to approval by the FDA for the treatment of DPT burns. The primary outcome measure was the number of participants with adverse events and safety concerns.

Conditions

Deep Partial-thickness Burn

Keywords

Alternative to Autograft

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. A TEAE is defined as an adverse event that started on or after the start of treatment (i.e. placement of StrataGraft).

  AEs were collected on each individual participant for the duration of their study participation, i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).

Study Arms (1)

StrataGraft

EXPERIMENTAL

On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 DPT wound(s) totaling no more than approximately 2000 square centimeters (cm\^2) in area.

Biological: StrataGraft skin tissue

Interventions

StrataGraft skin tissue BIOLOGICAL

StrataGraft skin tissue was delivered as a single topical application to no more than 3 separate burn sites, totaling up to approximately 2000 cm\^2 of treatment area using no more than 20 tissues.

Also known as: Experimental skin tissue

StrataGraft

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent
• Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
• Have protocol-defined thermal burn(s) on the torso, upper extremities and lower extremities:
• that are the right size for treatment areas,
• with intact dermal elements for which excision and autografting are clinically indicated, and
• have not been previously excised and grafted.

You may not qualify if:

• A participant must be excluded from participation if he/she:
• Is pregnant, a prisoner, or expected to live less than 3 months
• Has any other condition that, per protocol or in the opinion of the investigator, may compromise the participant's safety or the study objectives
• Has participated in an investigational study within 90 days before enrollment

Sponsors & Collaborators

• Stratatech, a Mallinckrodt Company: lead

Study Sites (10)

University of California Irvine

Orange, California, 92868-3298, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida (Health Shands Burn Center)

Gainesville, Florida, 32610, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Baton Rouge General

Baton Rouge, Louisiana, 70809, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70113, United States

Location

University of Missouri

Columbia, Missouri, 33136, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

University of Wisconsin Hospital

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Holmes Iv JH, Gibson ALF, Short T, Joe VC, Litt J, Carson J, Carter JE, Wibbenmeyer L, Hahn H, Smiell JM, Rutan R, Wu R, Shupp JW. A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft(R) treatment in adults with deep partial-thickness thermal burns. Burns. 2024 Nov;50(8):2013-2022. doi: 10.1016/j.burns.2024.05.023. Epub 2024 Jun 6.

  PMID: 39043513 DERIVED

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt

medinfo@mnk.com

800-844-2830

Study Officials

• Global Clinical Leader

  Stratatech, a Mallinckrodt Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2019
• First Posted: October 11, 2019
• Study Start: February 18, 2020
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: November 9, 2023
• Results First Posted: November 9, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)