Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy

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.