Combined Regulatory T-Lymphocyte and IL-2 Treatment Is Safe, Tolerable, and Biologically Active for 1 Year in Persons With Amyotrophic Lateral Sclerosis.

ABSTRACT:

Background and objectives

In a phase 1 amyotrophic lateral sclerosis (ALS) study, autologous infusions of expanded regulatory T-lymphocytes (Tregs) combined with subcutaneous interleukin (IL)-2 were safe and well tolerated. Treg suppressive function increased and disease progression stabilized during the study. The present study was conducted to confirm the reliability of these results.

Methods

Participants with ALS underwent leukapheresis, and their Tregs were isolated and expanded in a current Good Manufacturing Practice facility. Seven participants were randomly assigned in a 1:1 ratio to receive Treg infusions (1 × 10⁶ cells/kg) IV every 4 weeks and IL-2 (2 × 10⁵ IU/m²) injections 3 times/wk or matching placebo in a 24-week randomized con

SUBMITTER: Thonhoff JR 

PROVIDER: S-EPMC9423710 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature