Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus Type 1; Autoimmune Diseases; Endocrine System Diseases; Glucose Metabolism Disorders; Immune System Diseases; Metabolic Diseases
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      Patients with T1DM depend on administration of exogenous insulin for survival and for control
      of long-term complications. The best-established treatment is constricted control of blood
      glucose accomplished by regular daily injections or constant subcutaneous infusion of insulin
      as intensive insulin therapy. Although insulin therapy has advanced immensely, even the most
      modern technologies do not allow the maintenance of normal glucose levels.

      This is a prospective pilot study intended to treat patients with T1DM after at least one
      year of confirmed diagnosis. This study encompasses a two-arm approach; the first arm is
      composed of clinical-grade purification of autologous, leukapheresis-derived, Cluster of
      differentiation 34+ and 133+ stem cells (accomplished by utilisation of CliniMACS System and
      approved clinical-grade Microbeads and accessories), and transplantation of the purified ell
      populations into pancreatic artery and capillaries via interventional radiology techniques;
      while the second arm aims at halting the immune attack on pancreatic β-cells through
      immunomodulation, and is composed of incubation of patient's leukapheresis with cord
      blood-derived mesenchymal stem cells for 3-6 hours, and return of the patient's own white
      blood cells back into the patient via intravenous injection. Patients are first mobilised
      with 10 ug/Kg Granulocyte-Colony Stimulating Factor (GCSF) for five day, and then Mononuclear
      Cells are collected from the patient via leukapheresis.
    

Intervention name(s): Stem Cell Transplantation
Intervention type(s): Biological
Intervention description(s): Interventional radiology-mediated transplantation of purified, autologous stem cells into pancreatic artery and capillaries, and intravenous injection of autologous, immunomodulated mononuclear cells.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stem Cells; Transplantation; Immunomodulation; CD34; CD133; ClinicMACS