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Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor's cellular immunotherapy products: the MDR-105-SAE

Kant, Sam ; Kaufman, Dixon B ; Micsa, Lenuta ; Brennan, Daniel C

Current controlled trials in cardiovascular medicine, 2023-03, Vol.24 (1), p.178-178, Article 178 [Periódico revisado por pares]

England: BioMed Central Ltd

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Título:
Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor's cellular immunotherapy products: the MDR-105-SAE
Autor: Kant, Sam ; Kaufman, Dixon B ; Micsa, Lenuta ; Brennan, Daniel C
Assuntos: Clinical trials ; Drug dosages ; Drug withdrawal ; Graft Rejection ; Graft versus host disease ; Health aspects ; Humans ; Immunosuppression ; Immunosuppression Therapy - methods ; Immunosuppressive Agents - adverse effects ; Immunotherapy ; Informed consent ; Kidney transplantation ; Kidney Transplantation - adverse effects ; Kidney transplants ; Kidneys ; Lymphocytes ; Organ transplant recipients ; Patient outcomes ; Social aspects ; Study Protocol ; Tolerance ; Transplantation ; Vital signs
É parte de: Current controlled trials in cardiovascular medicine, 2023-03, Vol.24 (1), p.178-178, Article 178
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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Descrição: Immunosuppression in transplantation continues to be associated with a multitude of adverse effects. Induction of immune tolerance may be a viable strategy to reduce dependence on immunosuppression. Various trials are currently underway to assess the efficacy of this strategy. However, long-term safety data for these immune tolerance regimes has yet to be established. At the completion of primary follow-up of various Medeor kidney transplant studies, subjects receiving cellular immunotherapy products will be followed annually as per protocolized schedule for up to an additional 84 months (7 years) to evaluate long-term safety. Long-term safety will be assessed by summarizing incidence of serious adverse events, adverse events leading to study withdrawal and hospitalization rates. This extension study will be an important step in evaluating safety issues pertaining to immune tolerance regimens, long-term effects of which are largely unknown. These data are essential for furthering an unrealized goal of kidney transplantation- graft longevity without the adverse effects from long-term immunosuppression. The study design utilizes the methodology of a master protocol, wherein multiple therapies can be assessed simultaneously with accompanied gathering of long-term safety data.
Editor: England: BioMed Central Ltd
Idioma: Inglês

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Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor's cellular immunotherapy products: the MDR-105-SAE

Kant, Sam ; Kaufman, Dixon B ; Micsa, Lenuta ; Brennan, Daniel C

England: BioMed Central Ltd

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