Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen, sold under the brand name Stratagraft, is a medical treatment used for thermal burns containing intact dermal elements.
Common side effects include pruritus (itching), blisters, hypertrophic scar, and impaired healing (stalled healing process) at the treatment site.
Stratagraft is produced from two kinds of human skin cells (keratinocytes and dermal fibroblasts) grown together to make a bi-layered construct (a cellularized scaffold).
Since the human keratinocyte cells were grown with mouse cells during initial stages of product development, Stratagraft is formally considered to be a xenotransplantation product (involving tissues or cells belonging to different species).
Mouse cells are no longer used in the final manufacturing process.
It was approved for medical use in the United States in June 2021.
[ ]
Medical uses
Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) is
indicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).
History
The US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) evaluated the effectiveness and safety of Stratagraft based on two randomized clinical studies involving a total of 101 adult participants with deep partial thickness thermal burns.
In both studies, two deep partial-thickness burn wounds of comparable area and depth on each participant were identified and randomized to receive either a single topical application of Stratagraft or autograft.
The effectiveness is demonstrated by the percentage of Stratagraft treatment sites that achieved a complete wound closure, and the significantly decreased need for autografts at the Stratagraft treatment sites.
The FDA granted Stratagraft regenerative medicine advanced therapy,
priority review
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program ...
, and
orphan drug
An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by th ...
designations for this indication.
Stratagraft was developed in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
The FDA granted approval to Stratatech, a
Mallinckrodt
Mallinckrodt Pharmaceuticals plc is an American-Irish domiciled manufacturer of specialty pharmaceuticals (namely, adrenocorticotropic hormone), generic drugs and imaging agents. In 2017, it generated 90% of its sales from the U.S. healthcare s ...
company.
References
Medical treatments
Orphan drugs
{{dermatologic-drug-stub