T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs (Treg)
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|ClinicalTrials.gov Identifier: NCT01210664|
Recruitment Status : Completed
First Posted : September 28, 2010
Results First Posted : July 11, 2018
Last Update Posted : July 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Biological: Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Safety Trial of CD4+CD127lo/-CD25+ Polyclonal Treg Adoptive Immunotherapy for the Treatment of Type 1 Diabetes|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||January 2017|
Experimental: Polyclonal Regulatory T Cells
Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells by infusion
Biological: Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells
The researchers will multiply/expand the Tregs in the laboratory using anti-CD3/anti-CD28 coated beads plus IL-2. Then, the Tregs will be infused back into the patient in a single infusion. The first cohort will receive 0.05 x10^8 cells. The second cohort will receive 0.4 x10^8 cells. The third cohort will receive 3.2 x10^8 cells. The fourth cohort will receive 26 x10^8 cells.
Other Name: Tregs
- Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Mean follow-up of 31 months ]The number of AEs are reported by cohort and severity.
- Number of Participants Experiencing Severe or Life Threatening Laboratory Abnormalities [ Time Frame: Mean follow-up of 31 months ]
Laboratory measures tested include: hematology, blood chemistry, endocrine values, autoantibodies, and ophthalmologic exam results
Total number of participants experiencing severe or life-threatening laboratory abnormalities is reported for each cohort. Events reported include hyperglycemia and hypoglycemia.
- Percent Change From Baseline in C-peptide Area Under the Curve [ Time Frame: 26 and 52 weeks from baseline ]Secondary diabetes-related outcome measure: C-peptide response during mixed meal tolerance test at 26 and 52 weeks, reported as the change from baseline in the area under the curve.
- Insulin Use [ Time Frame: up to 104 weeks ]Secondary diabetes-related outcome measure will include insulin use
- Hemoglobin A1c [ Time Frame: Up to 104 weeks ]Secondary diabetes-related outcome measure will include hemoglobin A1c
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210664
|United States, California|
|University of California, San Francisco Medical Center|
|San Francisco, California, United States, 94143|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06519|
|Study Chair:||Stephen E Gitelman, MD||University of California, San Francisco|
|Study Director:||Jeffrey Bluestone, PhD||University of California, San Francisco|
|Principal Investigator:||Kevan Herold, MD||Yale University|