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T-Regulatory Cells in Amyotrophic Lateral Sclerosis

NCT03241784 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-03-26

No results posted yet for this study

Summary

This is an open-label pilot study to determine the safety and tolerability of infusions of autologous CD4+ CD25+ regulatory T cells with concomitant subcutaneous IL-2 injections in 4 subjects with ALS.

Conditions

  • ALS (Amyotrophic Lateral Sclerosis)

Interventions

BIOLOGICAL

Autologous T-regulatory lymphocytes

intravenous administration of Autologous T-regulatory lymphocytes at a dose of 1x10 to the sixth /kg.

BIOLOGICAL

Interleukin-2

Subcutaneous Interleukin-2 at a dose of 2x10 to the fifth IU/m2, three times a week.

Sponsors & Collaborators

  • Stanley H. Appel, MD

    lead OTHER

Principal Investigators

  • Stanley H Appel, MD · Houston Methodist Neurological Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-16
Primary Completion
2018-02-28
Completion
2018-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03241784 on ClinicalTrials.gov