Allogeneic processed thymus tissue

Thymus tissue medical therapy From Wikipedia, the free encyclopedia

Allogeneic processed thymus tissue, sold under the brand name Rethymic, is a thymus tissue therapy used for the treatment of children with congenital athymia.[3] It is administered via a one-time surgical procedure where the tissue slices are implanted into the quadriceps muscle.[2] It takes six months or longer to reconstitute the immune function in treated people.[3]

Trade namesRethymic
Other namesRVT-802,[1] allogeneic processed thymus tissue-agdc
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Allogeneic processed thymus tissue
Clinical data
Trade namesRethymic
Other namesRVT-802,[1] allogeneic processed thymus tissue-agdc
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The most common adverse reactions include high blood pressure, cytokine release syndrome, low blood magnesium levels, rash, low platelets, and graft versus host disease.[3]

It was approved for medical use in the United States in October 2021.[3][4][5] Allogeneic processed thymus tissue is the first thymus tissue product approved by the U.S. Food and Drug Administration (FDA).[3]

Allogeneic processed thymus tissue is composed of human allogeneic (donor-derived) thymus tissue that is processed and cultured, and then implanted into people to help reconstitute immunity (improve immune function) in people who are athymic.[3][6] Dosing is patient customized, determined by the surface area of the allogeneic processed thymus tissue slices and the body surface area of the patient.[3]

Medical uses

Allogeneic processed thymus tissue is indicated for immune reconstitution in children with congenital athymia.[2][5]

History

The safety and efficacy of allogeneic processed thymus tissue were established in clinical studies that included 105 participants, with ages from one month to 16 years, who each received a single administration of allogeneic processed thymus tissue, from 1993 to 2020.[3] Allogeneic processed thymus tissue improved survival of people with congenital athymia, and most people treated with this product survived at least two years.[3]

The U.S. Food and Drug Administration (FDA) granted the application for allogeneic processed thymus tissue a rare pediatric disease voucher and granted approval of Rethymic to Enzyvant Therapeutics, Inc.[3]

References

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