MedPath

Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen

Generic Name
Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen
Brand Names
StrataGraft
Drug Type
Biotech

Overview

Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) is an allogeneic cellularized scaffold product used for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (also known as deep partial-thickness burns). It was developed as an alternative to autografting - the process by which a patient's own skin is harvested and grafted onto the burn site - which has the disadvantage of creating a new wound at the site from which the graft is taken. Stratagraft consists of two kinds of lab-grown skin cells, keratinocytes and dermal fibroblasts, which are grown together on a murine collagen matrix to make a bi-layered construct (i.e. a cellularized scaffold). Sheets containing this scaffold product are applied to the burn site and, as they contain metabolically active and viable cells, provide a variety of human growth factors and cytokines as well as extracellular matrix proteins, all of which are known to be involved in wound repair. The product does not remain permanently engrafted, instead being replaced by the patient's own cells over time, which can reduce or even eliminate the need for autografting. Stratagraft was in the early stages of development as far back as 2009 and was granted full FDA approval in June 2021.

Indication

Stratagraft is an allogeneic cellularized scaffold product indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).

Associated Conditions

  • Deep partial-thickness thermal burn

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2022/08/26
Phase 3
Completed
Stratatech, a Mallinckrodt Company

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Stratatech Corporation
73612-200
TOPICAL
1 cm2 in 1 cm2
1/31/2024
Stratatech Corporation
73612-201
TOPICAL
1 cm2 in 1 cm2
1/31/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.