What is STRATAGRAFT or (allogeneic cultured keratinocytes and dermal fibroblasts
in murine collagen-dsat)?
STRATAGRAFT is the trade name of ‘allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat’. It is an innovative therapy developed by Stratatech Corporation, a Mallinckrodt company. STRATAGRAFT is indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns) – As per the US FDA. This is among the first few products to be designated as Regenerative Medicine Advanced Therapy (RMAT). To be precise, STRATAGRAFT is the first approved donor site-free alternative to autograft. It is approved for treating deep partial-thickness burns designed to handle like an autograft and support body’s own ability to heal.
STRATAGRAFT – FDA Approved Cellular and Gene Therapy Product
STRATAGRAFT secured its US FDA approval in June 2021. This approval was based on two randomized clinical studies involving a total of 101 adult patients with deep partial thickness thermal burns. A single tropical application of STRATAGRAFT is compared with autograft. The effectiveness evaluated based on the complete wound closure showed significant outcomes with STRATAGRAFT. A significant reduction in the need for autografts at the treatment sites is noteworthy. This provides burn surgeons a better alternative to possibly eliminate autografting. STRATAGRAFT was granted Priority Review and Orphan Drug designations by the FDA apart from RMAT. More information can be found in the US FDA Press Release.
How does treatment with PROVENGE (Sipuleucel-T) work?
It is a bioengineered, allogeneic cellularized scaffold product that is developed from keratinocytes grown on gelled collagen containing dermal fibroblasts. Supplied as STRATAGRAFT constructs, it is applied to a surgically prepared wound bed. It can be trimmed as per the size and shape of the wound bed. A STRATAGRAFT construct is an approximately 100 cm2 (approximately 8 cm by 12.5 cm) off-white rectangle. STRATAGRAFT is to be prepared in an appropriate surgical environment as per the specifications mentioned in the PI. It is recommended for tropical application only. Caution – STRATAGRAFT contains cells from human donors and may transmit infectious diseases or infectious agents, e.g., viruses, bacteria, or other pathogens, including the agent that causes transmissible spongiform encephalopathy (TSE, also known as Creutzfeldt-Jakob disease (CJD) or variant CJD). Refer to the STRATAGRAFT Prescribing Information for more specific details.
Patients and caregivers can visit www.stratagraft.com for comprehensive information. The website provides avenues to find a treatment center and option to register. Patients can also reach out to the company through StrataGraft Support.
STRATAGRAFT in India – Is there a possibility?
Right now there is limited information about STRATAGRAFT India. There is no active presence of Stratatech Corporation in the Indian market. More information is likely to emerge in the future to come. You can write to us at nhs@noelgenomics.com to express your interest. We are committed to provide authentic access information and assist Indian patients with advanced therapeutic solutions.
