Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- The incidence of treatment-emergent adverse events. [ Time Frame: Month 12 ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01947569
|Contact: Orville G. Kolterman, MDemail@example.com|
|Contact: Peter Gregoire, MBAfirstname.lastname@example.org|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator: Mary Korytokowski, MD|