Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes Mellitus

Type 1 diabetes mellitus (T1DM) is a chronic, autoimmune condition that involves the progressive destruction of pancreatic β-cells, eventually resulting in the loss of insulin production and secretion. Hence, an effective treatment for T1DM should focus on controlling anti-β-cell autoimmunity, combined with regeneration of lost pancreatic β-cell populations, with minimal risk to the patient.

This is a phase I and II clinical trial for treatment of patient with confirmed diagnosis of T1DM for at least 12 months prior to enrolment in this trial. This study aims to determine the combined effects of autologous stem cell transplantation and immunomodulation, on regeneration of lost β-cells and halting the immune attack on the pancreatic β-cells, respectively.


Study Type: Interventional
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Transplantation of Autologous Stem Cells Into Pancreatic Artery, Combined With Immunomodulation for the Treatment of Type 1 Diabetes Mellitus
Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Stem Cell Transplantation