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T-regulatory Cells in ALS

Study acronym: Tregs in ALS
StatusActive, Not Recruiting
PhasePhase 2
Started
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.

Record History

  1. Primary completion date: May 31, 2021 to May 31, 2022 Primary endpoint revised · Completion date: Aug 31, 2021 to Aug 31, 2022 · Secondary endpoints: 5 to 3 · 1 morev8 Show 4 more changesShow less
    • Primary endpoint revised
    • Completion date: Aug 31, 2021 to Aug 31, 2022
    • Secondary endpoints: 5 to 3
    • Study description expanded, about 179 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv7
  3. Primary completion date: Sep 1, 2024 to May 31, 2021 Completion date: Nov 30, 2024 to Aug 31, 2021 · Eligibility criteria expanded, about 24 words · Study description revised · 1 morev6 Show 4 more changesShow less
    • Completion date: Nov 30, 2024 to Aug 31, 2021
    • Eligibility criteria expanded, about 24 words
    • Study description revised
    • Study sites revised (2)

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 2 of 2 sitesv5 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  5. Primary endpoint revised Start date: Aug 8, 2019 to Aug 7, 2019 · Secondary endpoints revised (5) · Site details revised at 1 of 2 sitesv4 Show 3 more changesShow less
    • Start date: Aug 8, 2019 to Aug 7, 2019
    • Secondary endpoints revised (5)
    • Site details revised at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Sep 1, 2023 to Sep 1, 2024 · Completion date: Nov 30, 2023 to Nov 30, 2024 · Start date changed from estimate of Sep 1, 2019 to Aug 8, 2019 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Sep 1, 2023 to Sep 1, 2024
    • Completion date: Nov 30, 2023 to Nov 30, 2024
    • Start date changed from estimate of Sep 1, 2019 to Aug 8, 2019
    • Site details revised at 2 of 2 sites
  2. Site contacts updated at 2 of 2 sitesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov