Type 1 Diabetes Clinical Trial
Official title:
Autologous Dendritic Cell Therapy for Type 1 Diabetes Suppression: A Safety Study
Verified date | February 2016 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 2016 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: Patients with established type 1 diabetes mellitus who meet all inclusion criteria are eligible for enrollment in the study. - All patients enrolled must be on insulin replacement therapy. - Written informed consent conforming to the institutional guidelines obtained from the patient. - Documented evidence of insulin-requiring type 1 diabetes of >5 years duration. - Adequate immune competence, as indicated by positive reaction to one or more of the common DTH skin tests that are part of the Multitest CMITM test system (Pasteur-Merieux Connaught) and as indicated by the manufacturer. Also, proof of vaccination for tetanus (no more than 10 years must have elapsed between tetanus vaccination and the onset of this study). - Age 18-35. - Adequate hematologic function: - Absolute neutrophil count > 1,000/mm3 - Absolute lymphocyte count > 1,000/mm3 - Hemoglobin > 9 gm/dl - Platelets > 100,000/mm3 - Liver function tests: - Bilirubin (total) < 1.7 mg/dl - Alkaline phosphatase < 78 u/L (2 x ULN) - SGOT < 54 u/L (2 x ULN) - Lactic dehydrogenase < 180 u/L (2 x ULN) - Kidney profile: - Serum electrolytes - Sodium 135-145 mEq/L - Potassium 3.5-5.0 mEq/L - Bicarbonate 21-28 mEq/L - Chloride 100-108 mmol/L - Serum creatinine <4.5 mg/dL (3 x ULN) - BUN 8-25 mg/dL - No prior history of radiation therapy, immunotherapy, or chemotherapy - Evidence of prior immunization to tetanus - Absence of HIV, HSV, HBV, HCV viral infections - At least four weeks since any prior radiation , immunotherapy or chemotherapy Exclusion Criteria: - One or more of the Eligibility Criteria are not met. - A significant history or current evidence of cardiac disease including, but not limited to, congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrhythmias; or myocardial infarction within the previous six months. - Evidence of active infection requiring antibiotic therapy. - History of other concurrent diseases. - Pregnant or lactating women. - Patients requiring systemic corticosteroids - Any other immune disorder including but not limited to other autoimmune diseases like rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis - Pregnancy - History of radiation therapy, immunotherapy, or chemotherapy - Breastfeeding - The following therapies cannot be administered while patients are undergoing treatment on this protocol: - radiation therapy - chemotherapy - corticosteroids (except when administered in life-threatening circumstances) other particle or cell vaccine therapies 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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Harnaha J, Machen J, Wright M, Lakomy R, Styche A, Trucco M, Makaroun S, Giannoukakis N. Interleukin-7 is a survival factor for CD4+ CD25+ T-cells and is expressed by diabetes-suppressive dendritic cells. Diabetes. 2006 Jan;55(1):158-70. — View Citation
Machen J, Harnaha J, Lakomy R, Styche A, Trucco M, Giannoukakis N. Antisense oligonucleotides down-regulating costimulation confer diabetes-preventive properties to nonobese diabetic mouse dendritic cells. J Immunol. 2004 Oct 1;173(7):4331-41. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The trial is designed to assure that the toxicity rate is acceptably low to warrant further study of the cell vaccine in efficacy trials. | June 2011 | Yes |
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