This study is testing a treatment called RAPA-501 Autologous T stem cells for people with Amyotrophic Lateral Sclerosis (ALS). RAPA-501 is made from your own cells, which are specially prepared to have anti-inflammatory properties. The main goal of this study is to see if RAPA-501 is safe and practical to give at a dose of 80 x 10^6 cells per infusion. You might be able to join if you are 18 or older, have been diagnosed with ALS within the last 24 months, and have an ALSFRS-R score (a measure of ALS severity) between 34 and 45. This study is currently unclear about its recruitment status.

Study design

This is an open-label, non-randomized, multi-center study. It is a phase 2/3 expansion cohort, planning to enroll 41 participants.

What's involved

You would undergo an apheresis procedure to collect your cells. You would then receive up to 4 infusions of RAPA-501, given six weeks apart, over 18 weeks.

Compensation

Not stated in the trial record.

Follow-up

The primary endpoint for safety and feasibility is measured through 30 weeks on-study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.