BENITIONSClinical Trial Intelligence

Ph1 T-Regulatory Cells in Amyotrophic Lateral Sclerosis

Phase 1 Completed NCT03241784

ConditionALS
PhasePhase 1
SponsorThe Methodist Hospital Research Institute
StatusCompleted
Enrollment3 participants
InterventionsAutologous T-regulatory lymphocytes, Interleukin-2
Start dateMay 16, 2016
Completion dateJan 5, 2018
Results postedJun 17, 2026

Summary

Open-label pilot study to determine the safety and tolerability of autologous CD4+ CD25+ regulatory T cells infusions with concomitant subcutaneous IL-2 injections taken 3 times per week in 3 participants with ALS.

Number of Participants With Treatment-related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.0) & Medical Dictionary for Regulatory Activities (MedDRA).

Adverse events related to Treg infusions at Baseline to up to two years or study participation, whichever is occurs first. · Participants

Treatment Arm0 Participants

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