Status:
COMPLETED
T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The investigational therapy under study in this trial, regulatory T cells (Tregs), offers the hope of stabilizing further destruction of insulin producing beta cells in type 1 diabetes. Tregs are a sp...
Detailed Description
Currently, there is no approved medical treatment for preservation of the body's ability to produce insulin in patients with Type 1 Diabetes Mellitus (T1DM), and the progression of the disease can hav...
Eligibility Criteria
Inclusion
- Diagnosis of T1DM within \>3 and \<24 months of screening according to the American Diabetes Association criteria
- Between 18 and 45 years of age
- Positive test for Epstein-Barr antibody
- Positive test for at least one of the following antibodies:
- ICA512-antibody
- ICA
- GAD65-antibody
- Insulin (if assessed within 10 days of the onset of insulin therapy)
- ZnT8
- Peak C-peptide \>0.1 pmol/ml (\>0.3 ng/ml) during MMTT challenge
- Adequate venous access to support draw of 400 ml whole blood and infusion of investigational therapy
Exclusion
- Hemoglobin \<10.0 g/dL; leukocytes \<3,000/µL; neutrophils \<1,500/µL; lymphocytes \<800/µL; platelets \<100,000/µL
- Regulatory T cells present in peripheral blood at \<10 per µl as determined by flow cytometry
- Serologic evidence of HIV-1 or HIV-2 infection
- Evidence of current hepatitis B as demonstrated by HBsAg or circulating hepatitis B genomes
- Serologic evidence of hepatitis C infection
- Detectable circulating EBV or CMV genomes or active infection
- Positive PPD skin test defined as greater than or equal to 10 mm induration
- Chronic use of systemic glucocorticoids or other immunosuppressive agents, or biologic immunomodulators within 6 months prior to study entry. Specifically, subjects who have received over 7 days of treatment with 7.5mg of prednisone (or the equivalent) within 6 months prior to study entry will be excluded.
- History of malignancy ( including squamous cell carcinoma of the skin or cervix) except adequately treated basal cell carcinoma
- Any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial
- Pregnant or breastfeeding women, any female who is unwilling to use a reliable and effective form of contraception for 2 years afer Treg dosing and any male who is unwilling to use a reliable and effective form of contraception for 3 months after Treg dosing.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01210664
Start Date
November 1 2010
End Date
January 1 2017
Last Update
July 11 2018
Active Locations (2)
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1
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
2
Yale University
New Haven, Connecticut, United States, 06519