Status and phase
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About
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.
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Inclusion and exclusion criteria
Inclusion Criteria:(both open label phase IB safety and Phase IIA study):
Exclusion Criteria:(both open label phase IB safety and Phase IIA study):
Primary purpose
Allocation
Interventional model
Masking
90 participants in 3 patient groups, including a placebo group
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Central trial contact
Peter Gregoire, MBA; Orville G. Kolterman, MD
Data sourced from clinicaltrials.gov
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