Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy
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.
Treatment of Type I Diabetes Mellitus.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- The incidence of treatment-emergent adverse events. [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: iDC recipients
iDC cells modified by in vitro engineering.
Active Comparator: Control DC recipients
DC cells which have not been modified.
Placebo Comparator: Placebo recipients
Please refer to this study by its ClinicalTrials.gov identifier: NCT01947569
|Contact: Orville G. Kolterman, MDfirstname.lastname@example.org|
|Contact: Peter Gregoire, MBAemail@example.com|
|United States, Pennsylvania|
|UPMC||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator: Mary Korytokowski, MD|