Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy

Status unconfirmed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Treatment of Type I Diabetes Mellitus.

In brief

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.

Key facts

Study ID
NCT01947569
Run by
DiaVacs, Inc.
People needed
90
Starts
2013-10-01
Last updated by the study team
2013-10-23

Who can join

Age: 12 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.