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Immunotherapy

Treatment arm for Lou Gehrig's Disease

Phase 1
Waitlist Available
Led By Stanley H Appel, MD
Research Sponsored by Stanley H. Appel, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older.
Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria (Appendix 1).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to two years
Awards & highlights

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.

Eligible Conditions
  • Lou Gehrig's Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcome measures
AALS (Appel ALS) Scale
ALSFRS-R (ALS Functional Rating Scale-Revised)
T-Regulatory Cells
+2 more
Other outcome measures
Pulmonary FVC - Exploratory Measure
Pulmonary MIP - Exploratory Measure
Tracheostomy- Exploratory Measure

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment armExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human interleukin-2
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Stanley H. Appel, MDLead Sponsor
Stanley H Appel, MDPrincipal InvestigatorHouston Methodist Neurological Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Tennessee
How old are they?
65+
What site did they apply to?
Methodist Neurological Institute
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Mar 2025