Autoimmune Diseases Clinical Trial
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
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.
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.
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