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Cell Therapy
Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections for Lou Gehrig's Disease (Tregs in ALS Trial)
Phase 2
Waitlist Available
Led By James D. Berry, MD, MPH
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ALS meeting El Escorial criteria for possible, probable, lab-supported probable, or definite ALS.
At least 18 years old.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 24
Awards & highlights
Tregs in ALS Trial Summary
This trial is studying if Tregs taken and expanded outside of the body and returned back to the same person, can help treat ALS when given in combination with low-dose IL-2.
Eligible Conditions
- Lou Gehrig's Disease
Tregs in ALS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTregs in ALS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Treg suppressive function in the blood from baseline to week 24.
Secondary outcome measures
Change in Treg numbers in the blood from baseline to week 24.
Tolerability of Treg infusions for 6 months of treatment
Tolerability of ascending doses of Tregs for 6 months of treatment
Tregs in ALS Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Intravenous infusion of Treg cells + Interleukin-2 injectionsExperimental Treatment1 Intervention
For the first six months: T-regulatory cells taken from a participant will be increased in numbers outside the body in a lab and then returned back to the same participant through intravenous (IV) infusions once per month. The participant will also take Interleukin-2 (IL2) injections three times per week.
Group II: 2nd 6-months Open Label: Treg Infusions + IL-2 injectionsExperimental Treatment1 Intervention
For second six months: All participants will receive their own expanded/increased in numbers Treg cells by monthly infusion plus 3 times per week subcutaneous injections of IL-2.
Group III: Intravenous infusion w/Placebo + matching placebo injectionsPlacebo Group1 Intervention
For the first six months: Participants will receive matching placebo or inactive intravenous (IV) infusions once per month. The participant will also take a matching inactive placebo injection three times per week.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalOTHER
2,922 Previous Clinical Trials
13,193,518 Total Patients Enrolled
The Methodist Hospital Research InstituteLead Sponsor
270 Previous Clinical Trials
80,246 Total Patients Enrolled
The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at HoustonOTHER
5 Previous Clinical Trials
442 Total Patients Enrolled
Frequently Asked Questions
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