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Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01947569
Recruitment Status : Unknown
Verified October 2013 by DiaVacs, Inc..
Recruitment status was:  Not yet recruiting
First Posted : September 20, 2013
Last Update Posted : October 23, 2013
Information provided by (Responsible Party):
DiaVacs, Inc.

Brief Summary:

Phase IB will evaluate the safety of autologous, ex vivo-engineered, co-stimulation impaired dendtritic cells to maintain and improve functional residual beta cell mass in new onset Type I Diabetes Mellitus (T1DM) patients. Efficacy measures will be collected and summarized.

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.

Condition or disease Intervention/treatment Phase
Treatment of Type I Diabetes Mellitus. Biological: Biological Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Autologous Co-stimulation-impaired Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy: A Sequential Open Label Phase IB Safety Assessment/ Randomized, Double-blind Phase IIA Efficacy Trial to Maintain and Improve Functional Beta Cell Mass in New Onset Disease T1DM Patients
Study Start Date : October 2013
Estimated Primary Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: iDC recipients
iDC cells modified by in vitro engineering.
Biological: Biological
Active Comparator: Control DC recipients
DC cells which have not been modified.
Biological: Biological
Placebo Comparator: Placebo recipients
Saline injections.
Biological: Biological

Primary Outcome Measures :
  1. The incidence of treatment-emergent adverse events. [ Time Frame: Month 12 ]

Secondary Outcome Measures :
  1. 2-hour area under the curve (AUC) average of C-peptide at 12 months after completion of administration of assigned therapy (Protocol Month 15). [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:(both open label phase IB safety and Phase IIA study):

  1. Patients with new onset T1DM (>18 years of age for the phase IB and then >16 (first 10 subjects), >12 years of age for the second 10 subjects, > 8 years for the next 10 subjects and, finally, >8 years of age for the remainder of the phase IIA patients) within 6 months of diabetes mellitus diagnosis.
  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:(both open label phase IB safety and Phase IIA study):

  1. Enrollment or history of enrollment in a drug, or biologic therapy study sponsored by TrialNet.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01947569

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Contact: Orville G. Kolterman, MD 7242085707
Contact: Peter Gregoire, MBA 7242085707

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United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Mary Korytokowski, MD         
Sponsors and Collaborators
DiaVacs, Inc.
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Responsible Party: DiaVacs, Inc. Identifier: NCT01947569    
Other Study ID Numbers: DV-0100-100
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases