Allogeneic processed thymus tissue

Allogeneic processed thymus tissue is used for immune reconstitution in immune disorders where the patients are severely immunocompromised due to the absence of a functional thymus, such as congenital athymia. As part of the immune system, the thymus is an organ responsible for the maturation and selection of T cells ; thus, patients without a functional thymus experience profound immunodeficiency and are placed at higher risk for developing life-threatening or fatal infections and immune dysregulation. Congenital athymia is a rare condition that leads to the absence of a thymus at birth and a high premature mortality rate, with patients typically dying by age two or three. Multiple factors contribute to the development of congenital athymia, such as genetic abnormalities, congenital syndromes, and environmental factors. Allogeneic processed thymus tissue implantation works by migrating the recipient’s bone marrow-derived stem cells to the implanted cultured thymus tissue that develops immunocompetent naïve T cells. On October 8, 2021, FDA approved allogeneic processed thymus tissue-agdc, under the market name RETHYMIC, as a one-time regenerative tissue-based therapy for immune reconstitution in pediatric patients with congenital athymia: this marks the first and only FDA-approved treatment for such therapeutic indication.

Allogeneic processed thymus tissue is used for immune reconstitution in immune disorders where the patients are severely immunocompromised due to the absence of a functional thymus, such as congenital athymia. As part of the immune system, the thymus is an organ responsible for the maturation and selection of T cells ; thus, patients without a functional thymus experience profound immunodeficiency and are placed at higher risk for developing life-threatening or fatal infections and immune dysregulation. Congenital athymia is a rare condition that leads to the absence of a thymus at birth and a high premature mortality rate, with patients typically dying by age two or three. Multiple factors contribute to the development of congenital athymia, such as genetic abnormalities, congenital syndromes, and environmental factors. Allogeneic processed thymus tissue implantation works by migrating the recipient’s bone marrow-derived stem cells to the implanted cultured thymus tissue that develops immunocompetent naïve T cells. On October 8, 2021, FDA approved allogeneic processed thymus tissue-agdc, under the market name RETHYMIC, as a one-time regenerative tissue-based therapy for immune reconstitution in pediatric patients with congenital athymia: this marks the first and only FDA-approved treatment for such therapeutic indication.

Allogeneic processed thymus tissue is indicated for immune reconstitution in pediatric patients with congenital athymia. It is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).

• Congenital athymia