Trial record 1 of 27 for:
Tregs | Diabetes
T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs (Treg)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Collaborators:
Juvenile Diabetes Research Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01210664
First received: September 23, 2010
Last updated: May 18, 2016
Last verified: May 2016
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| First Received Date ICMJE | September 23, 2010 | |||||||||
| Last Updated Date | May 18, 2016 | |||||||||
| Start Date ICMJE | November 2010 | |||||||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Number of Participants with Adverse events as a Measure of Safety and Tolerability. [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ] Primary outcome measures will be the number of participants with adverse events, laboratory abnormalities and other signs of toxicity. Particular focus will be on the number and severity of infusion reactions, complications related to infection, and any potential negative impact on the course of diabetes. |
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT01210664 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs | |||||||||
| Official Title ICMJE | A Phase I Safety Trial of CD4+CD127lo/-CD25+ Polyclonal Treg Adoptive Immunotherapy for the Treatment of Type 1 Diabetes | |||||||||
| 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 specialized subset of T cells that function to control the immune response. Pre-clinical studies in non-obese diabetic mice have demonstrated that adoptive transfer of Tregs can slow diabetes progression and, in some cases, reverse new onset diabetes. The primary purpose of this Phase 1 study is to assess the safety and feasibility of intravenous infusion of ex vivo selected and expanded autologous polyclonal Tregs in patients with type 1 diabetes (T1DM) to support dose selection for a future efficacy trial. The study also aims to assess the effect of Tregs on beta cell function as well as on other measures of diabetes severity and the autoimmune response underlying T1DM. | |||||||||
| 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 have devastating consequences. Inadequate blood glucose control results in many long term complications including kidney disease, blindness, amputation and nerve damage. In spite of the advances in insulin therapy and subsequent glucose control, patients are required to infuse insulin subcutaneously daily throughout their lives, monitor their diet and blood sugar levels, and deal with life-long uncertainties. The investigational therapy under study in this trial, regulatory T cells (Tregs), offers the hope of stabilizing diabetes. Tregs are a specialized subset of T cells that function to control the immune response. Pre-clinical studies in non-obese diabetic mice have demonstrated that adoptive transfer of Tregs can slow diabetes progression and, in some cases, reverse new onset diabetes. The primary objective of this study is to assess the safety of a single intravenous infusion of Tregs in patients with T1DM. The study will also assess the effect of Tregs on insulin-producing beta cell function as well as other outcomes related to diabetes management. Researchers will isolate Tregs from the patient's own blood using specific T cell surface markers (CD4, CD25, and CD127). This subset of cells is then expanded in the laboratory by co-stimulating with anti-CD3 and anti-CD28 immobilized on magnetic beads, and with the use of growth medium containing human serum and IL-2. Following the 14-day expansion, anti-CD3/anti-CD28 beads will be removed and the Tregs will be concentrated and consolidated. The cells will then be resuspended in sterile infusion solution at the required concentration and infused back into the patient through a standard peripheral intravenous line. Subjects will be observed overnight in the clinical research center for any possible side effects following the infusion. A total of 14 subjects will be enrolled. The study will involve 4 dosing cohorts with 3 or 4 adults in each cohort. Each cohort will receive increasing amounts of Tregs. Subjects will be followed over five years to assess safety of the Treg therapy. | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase | Phase 1 | |||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Type 1 Diabetes Mellitus | |||||||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | 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
Intervention: Biological: Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Estimated Enrollment ICMJE | 14 | |||||||||
| Estimated Completion Date | March 2017 | |||||||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | |||||||||
| Ages | 18 Years to 45 Years (Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01210664 | |||||||||
| Other Study ID Numbers ICMJE | UCSFDC411AI, JDRF4-2005-1168 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| Plan to Share Data | Not Provided | |||||||||
| IPD Description | Not Provided | |||||||||
| Responsible Party | University of California, San Francisco | |||||||||
| Study Sponsor ICMJE | University of California, San Francisco | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | |||||||||
| Verification Date | May 2016 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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