Hematopoietic Stem Cell Support Versus Insulin in T1D
Status:
Withdrawn
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
Type 1 diabetes mellitus (T1D) results from immune-mediated destruction of insulin-producing
islet cells. The loss of islet cells is traditionally treated with insulin therapy and in
some cases pancreas or islet cell transplantation. Another approach would be to preserve
islet cell mass before it is irreversibly lost. Previous trials using immune suppression
within 6 weeks of T1D onset have demonstrated diminished exogenous insulin requirements
compared to untreated controls. In our prior phase I non-randomized study, by extending
immune suppression to the point of immune ablation / immune reset with autologous HSC
support, several patients with new onset T1D have maintained an insulin-free, drug free
remissions for more than 4 years. Although these results appear highly promising, it may be
argued that our results are mitigated by the documented honeymoon effect following T1D, that
is by a normal transient insulin free interval occurring after disease onset in some
patients. The goal of this trial is to extend this phase I study of new onset T1D to clarify
whether our post transplant insulin free interval is due to treatment intervention
(transplant) or a result of a normally occurring "insulin free honeymoon period". Both groups
will receive identical change of life style (i.e. diet, exercise) education.