Expanded autologous regulatory T-lymphocyte infusions in ALS: A phase I, first-in-human study.

ABSTRACT:

Objective

To determine whether autologous infusions of expanded regulatory T lymphoctyes (Tregs) into patients with amyotrophic lateral sclerosis (ALS) are safe and tolerable during early and later stages of disease.

Methods

Three patients with ALS, with no family history of ALS, were selected based on their differing sites of disease onset and rates of progression. Patients underwent leukapheresis, and Tregs were subsequently isolated and expanded ex vivo. Tregs (1 × 10⁶ cells/kg) were administered IV at early stages (4 doses over 2 months) and later stages (4 doses over 4 months) of disease. Concomitant interleukin-2 (2 × 10⁵ IU/m²/injection) was administered subcutaneously 3 times weekly over the entire study period. Patients were closely

SUBMITTER: Thonhoff JR 

PROVIDER: S-EPMC5961523 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature