Type 1 Diabetes Clinical Trial
Official title:
Transfusion of Autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children With Type 1 Diabetes - A Pilot Study.
Type 1 diabetes (T1D) is still associated with tremendous morbidity and premature mortality.
Patients require multiple daily insulin injections throughout their lives as well as close
monitoring of their diet and blood sugar levels to prevent complications. Unfortunately,
there is presently no permanent cure for diabetes. Whole pancreas or islet cell
transplantation is available only to a very limited number of patients and necessitates
potential lifelong immunosuppressive therapy. Autologous stem cell transplants have been
used successfully for ALL (acute lymphoblastic leukemia), AML (acute myeloblastic leukemia)
and for the treatment of a variety of cancers including breast cancer and neuroblastomas,
and more recently for the treatment of autoimmune disorders such as multiple sclerosis (MS),
lupus-like disease, and rheumatic disorders. Recently it was shown that bone marrow-derived
stems cells transplanted into diabetic mice led to reduced hyperglycemia within 7 days after
transplantation and was sustained until they were sacrificed at 35 days
post-transplantation. The investigators' goal is to transfuse autologous umbilical cord
blood into 23 children (Germany 10 and 20 Controls) with T1D in an attempt to regenerate
pancreatic islet insulin producing beta cells and improve blood glucose control. As
secondary goals, the investigators aim to track the migration of transfused cord blood stem
and study the potential changes in metabolism/immune function leading to islet regeneration.
n/a
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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