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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to two years
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 moreOther 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
Recent research and studies
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