The goal of this study is to evaluate safety and efficacy of bone marrow (BM) as site for pancreatic islet transplantationin humans. Our hypothesis is that BM represents a better site than liver (currently the location of choice for this procedure) thanks to its potential capacity to favor islet engraftment. To address our hypothesis we propose herein a randomized phase II trial to compare BM and liver as sites for islet transplantation in T1D patients.
The study is a phase II, single center, open label, pilot study. We will recruit 12 patients with T1D to be randomly (1:1) assigned to receive islet either into the liver through the portal venous circulation (standard procedure; arm A, n=6) or directly into the BM at the level of the iliac crest (arm B, n=6). Patients will be selected from those eligible for islet Tx based on local practice and guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Ospedale San Raffaele
Milan, Italy
Insulin secretion under stimulation
basal and -10 to 120 min time course of glucose, C-pep levels and insulin derived from the mixed meal tolerance test
Time frame: month 12 post-Tx
Incidence and severity of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: throughout the study up to 1 year after first transplant
Insulin requirement
Change in average daily insulin requirements
Time frame: month 1, 3, 6, 9, 12 post- transplant
Islet function
change in HbA1c, Transplant Estimated Function (TEF) and fasting C-peptide levels
Time frame: month 1, 3, 6, 9, 12 post-Tx
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