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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00445913 |
The proposed studies describe a randomized trial to evaluate the safety of a new diabetes-suppressive cell vaccine, consisting of autologous monocyte-derived dendritic cells treated ex vivo with antisense phosphorothioate-modified oligonucleotides targeting the primary transcripts of the CD40, CD80 and CD86 co-stimulatory molecules (immunoregulatory DC; iDC). The hypothesis to be tested in this study is that iDC are safe and without toxicity in established type 1 diabetic patients.
Fifteen (15) individuals exhibiting fully-established, insulin-dependent type 1 diabetics, without any diabetes-related complications, infectious disease, or other medical anomaly, will be enrolled to establish safety of the approach. 7/15 volunteers will be administered autologous control dendritic cells and 8/15 will be administered iDC. The study is anticipated to be complete by twelve (12) months.
Currently, other than a humanized anti-CD3 antibody with considerable side effects, there is no other means to reverse new-onset type 1 diabetes. These studies will be the first ever to employ autologous dendritic cell transfer to suppress an autoimmune disease and to perhaps reverse it early on in the clinical process.
Condition | Intervention | Phase |
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Type 1 Diabetes |
Biological: Diabetes-suppressive dendritic cell vaccine Biological: control dendritic cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study |
Official Title: | Autologous Dendritic Cell Therapy for Type 1 Diabetes Suppression: A Safety Study |
Estimated Enrollment: | 15 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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control dendritic cells: Experimental
autologous dendritic cells that are not treated
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Biological: control dendritic cells
The dendritic cells will be treated ex vivo with vehicle and cryopreserved in aliquots for subsequent intradermal administration into sites closest to the physical location of the pancreas inside the body. Physiologic, biologic and immunologic responses to these control dendritic cells will be evaluated over the period of the trial. The first group of volunteers will receive autologous dendritic cells without any ex vivo treatment (7/15) and the second group will be administered iDC (8/15). If there is no evidence of toxicity or adverse events associated with the dendritic cell vaccine, and only upon FDA and IRB approval we will initiate a new study comparing efficacy of control DC and iDC in improving glycemia and reversing autoimmunity in new-onset patients.
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AS ODN dendrtitic cells: Experimental
autologous dendritic cells treated ex vivo with the mixture of the antisense oligonucleotides
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Biological: Diabetes-suppressive dendritic cell vaccine
The dendritic cells will be treated ex vivo with the antisense oligonucleotides and cryopreserved in aliquots for subsequent intradermal administration into sites closest to the physical location of the pancreas inside the body. Physiologic, biologic and immunologic responses to the dendritic cell vaccine will be evaluated over the period of the trial. The first group of volunteers will receive autologous dendritic cells without any ex vivo treatment (7/15) and the second group will be administered iDC (8/15). If there is no evidence of toxicity or adverse events associated with the dendritic cell vaccine, and only upon FDA and IRB approval we will initiate a new study comparing efficacy of control DC and iDC in improving glycemia and reversing autoimmunity in new-onset patients.
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients with established type 1 diabetes mellitus who meet all inclusion criteria are eligible for enrollment in the study.
Adequate hematologic function:
Liver function tests:
Kidney profile:
Serum electrolytes
Exclusion Criteria:
The following therapies cannot be administered while patients are undergoing treatment on this protocol:
At the time of screening, the patients will be tested for evidence of the following viral infections: HIV, HBV, HCV, herpes, CMV and EBV. In addition, female volunteers will be asked to provide documentation from their physician stating that they have not tested positive for the HPV viral infection. Only patients testing negative for ALL these viral infections will be further considered. Should any volunteer be excluded on grounds of positivity for any of these infectious agents, they will be immediately notified and strongly advised to consult their physician. The data and the records will be maintained under lock and in the study participation file of the volunteer until the volunteer confirms in writing that they have notified their physician. At that time, these specific data may be submitted to the patient's physician ONLY DIRECTLY BY THE VOLUNTEER upon written request to the study principal investigator or immediately destroyed.
Contact: Brian Copeman | 412-692-6167 | brian.copeman@chp.edu |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Principal Investigator: Massimo Trucco, MD |
Principal Investigator: | Massimo Trucco, M.D. | University of Pittsburgh |
Responsible Party: | Rangos Research center ( Massimo Trucco, M.D. ) |
Study ID Numbers: | 0509115, NIH NIDDK 683044 |
Study First Received: | March 7, 2007 |
Last Updated: | November 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00445913 |
Health Authority: | United States: Food and Drug Administration |
type 1 diabetes dendritic cells cell vaccine safety reversal |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Pancrelipase |
Immune System Diseases |