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Cell Therapy
Cultured Treg cells for Graft-versus-Host Disease
Phase 1
Waitlist Available
Led By Joseph Pidala, MD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing if Tregs can prevent GVHD in HLA identical sibling transplants.
Eligible Conditions
- Graft-versus-Host Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximally Tolerated dose (MTD)
Secondary outcome measures
Acute GVHD incidence
Non-relapse Mortality
Overall Survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cultured Treg cellsExperimental Treatment1 Intervention
Co-culturing of recipient dendritic cells and donor Treg cells given prior to allogeneic stem cell transplant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cultured Treg cells
2014
Completed Phase 1
~40
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,457 Total Patients Enrolled
Joseph Pidala, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
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