At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite by revised El Escorial criteria
- ✓Not taken riluzole for at least 30 days OR on stable riluzole dose for at least 30 days
- ✓Capable of informed consent and following trial procedures
- ✕Prior use of cell therapies
- ✕Concurrent use of other experimental ALS therapies
- ✕Known immune deficiency, history of lymphoma or leukemia, or history of lymphopenia
- ✕History of acquired or inherited immune deficiency syndrome, including leukopenia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Expansion and Infusion of T-Regulatory Cells in Amyotrophic Lateral Sclerosis
In Brief
A Phase 1 clinical trial evaluating Autologous T-regulatory lymphocytes and Interleukin-2 for ALS (Amyotrophic Lateral Sclerosis). Completed, enrolled 3 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
All subjects are enrolled in the one arm consisting of infusions of autologous T-regulatory lymphocytes at a dose of 1x10 to the sixth/kg and subcutaneous injections of Interleukin-2 at a dose of 2x10 to the fifth IU/m2 three times a week.
Interventions
intravenous administration of Autologous T-regulatory lymphocytes at a dose of 1x10 to the sixth /kg.
Subcutaneous Interleukin-2 at a dose of 2x10 to the fifth IU/m2, three times a week.