Allogeneic processed thymus tissue
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| Trade names | Rethymic |
| Other names | RVT-802,[1] allogeneic processed thymus tissue-agdc |
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| E number | {{#property:P628}} |
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| ECHA InfoCard | {{#property:P2566}}Lua error in Module:EditAtWikidata at line 29: attempt to index field 'wikibase' (a nil value). |
Allogeneic processed thymus tissue, sold under the brand name Rethymic, is a thymus tissue medical therapy used for the treatment of children with congenital athymia.[4] It takes six months or longer to reconstitute the immune function in treated people.[4]
The most common adverse reactions include high blood pressure, cytokine release syndrome, low blood magnesium levels, rash, low platelets, and graft versus host disease.[4]
It was approved for medical use in the United States in October 2021.[4][5][6] Allogeneic processed thymus tissue is the first thymus tissue product approved by the U.S. Food and Drug Administration (FDA).[4]
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.[4][7] Dosing is patient customized, determined by the surface area of the allogeneic processed thymus tissue slices and the body surface area of the patient.[4]
Medical uses
[edit | edit source]Allogeneic processed thymus tissue is indicated for immune reconstitution in children with congenital athymia.[2][6]
History
[edit | edit source]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.[4] Allogeneic processed thymus tissue improved survival of people with congenital athymia, and most people treated with this product survived at least two years.[4]
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.[4]
References
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Public Domain This article incorporates public domain material from the United States Department of Health and Human Services
Further reading
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