Treatment of Type I Diabetes Mellitus. Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment