Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy
NCT ID: NCT01947569
Last Updated: 2013-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2013-10-31
Brief Summary
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Phase IIA will evaluate the safety and efficacy of 3 randomized treatment groups in new onset T1DM patients to assess if the antisense DNA-treated co-stimulation-impaired immunoregulatory dendritic cells (iDC) will safely preserve and/or increase B-cell mass resulting in improvement and/or normalization of blood glucose levels and glycated hemoglobin A1c.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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iDC recipients
iDC cells modified by in vitro engineering.
Biological
Control DC recipients
DC cells which have not been modified.
Biological
Placebo recipients
Saline injections.
Biological
Interventions
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Biological
Eligibility Criteria
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Inclusion Criteria
2. Evidence of decreased β-cell function as measured by C-peptide and blood glucose levels consistent with impaired glucose tolerance.
3. Evidence of at least one high-risk HLA haplotype.
4. Evidence of at least one diabetes-related autoantibody (e.g. IA-2, GAD, ZnT8) ,
5. Adequate immune competence as assessed by immunoreactivity to alloantigens in mixed leukocyte culture and reactivity to viral antigens (CEF Pool Assay) in vitro.
6. Normal hematologic, liver and kidney function.
7. Female participants of childbearing potential in this study must agree to use an effective form of birth control during study participation. Reliable and effective forms of birth control include: true abstinence, intrauterine device (IUD), hormonal-based contraception, double-barrier contraception \[condom or occlusive cap (diaphragm or cervical cap) with spermicide\], or surgical sterilization (vasectomy for male partner, tubal ligation or hysterectomy). Sexually active male participants must agree to use an effective form of birth control such as condoms.
Exclusion Criteria
2. A significant history or current evidence of cardiac disease, uncontrolled hypertension, serious arrhythmias.
3. Evidence of active infection requiring antibiotic therapy.
4. History of other concurrent significant medical diseases.
5. Pregnant or lactating women.
6. Patients requiring chronic systemic corticosteroids.
7. Any other immune disorder including but not limited to other autoimmune diseases, HIV, HBV, HCV, HPV, HSV positivity.
8. Impaired renal function with a creatinine level \> 1.5.
9. Administration of the following therapies while patients are undergoing treatment on this protocol: i) radiation therapy; ii) chemotherapy; iii) corticosteroids (except when administered in life-threatening circumstances); iv) other particle or cell-based therapies; v) other biologic therapies; vi) other therapies aimed at modulating the immune system; vii) other endocrine-related therapies, hormone replacement (other than thyroxine and contraceptive), glucoregulation.
10. A hemaglobinopathy known to interfere with the ability to accurately determine HbA1c.
11. No prior radiation therapy, immunotherapy, or chemotherapy.
12 Years
35 Years
ALL
No
Sponsors
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DiaVacs, Inc.
INDUSTRY
Responsible Party
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Locations
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UPMC
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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DV-0100-100
Identifier Type: -
Identifier Source: org_study_id