Clinical Trial

T-regulatory Cells in ALS

Study acronym: Tregs in ALS
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated October 6, 2021 (before its estimated May 31, 2022 completion). Its status may not reflect the trial's current state.
Summary
This study is a randomized, placebo-controlled, phase 2a trial to study the biological activity, safety, and tolerability of regulatory T Lymphocytes (Tregs) taken and expanded outside of the body and returned back to the same person whose Treg were removed, given back by IV (intravenously) and in combination with low-dose IL-2 in people with Amyotrophic Lateral Sclerosis (ALS).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2019-08-12; most recent amendment 2026-03-27.
Status change: Active, Not Recruiting → Completed 2026-03-27
Status change: Recruiting → Active, Not Recruiting 2020-02-28
Status change: Not Yet Recruiting → Recruiting 2019-09-18
Trial Details
NCT Number NCT04055623
Lead Sponsor The Methodist Hospital Research Institute
Collaborators: Massachusetts General Hospital, The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston, North East Amyotrophic Lateral Sclerosis Consortium
Conditions ALS (Amyotrophic Lateral Sclerosis)
Enrollment 12 participants
Start Date 2019-08-07
Primary Completion 2022-05-31 (estimated)
Study Completion 2022-08-31 (estimated)
Updated on ClinicalTrials.gov 2021-10-06