A Phase 1/2 interventional study of Autologous bone marrow mononuclear cell transplantation in Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-04-25.
Sponsored by Shandong University · Phase 1/2, Interventional, and Treatment
The study evaluates the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating patients with type 1 or 2 Diabetes Mellitus. We hypothesize that autologous bone marrow stem cell transplantation will promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulated local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.
Patients with type 1 or 2 Diabetes mellitus will be recruited according to eligibility criteria. Bone marrow mononuclear cells (BMMCs) will be separated from the bone marrow aspirate of each patient and be directly delivered to pancreas via splenic artery with the distal lumen occlusion through an arterial catheter. All patients will be explained in details about the procedures involved in BMMC transplantation and sign the informed consent for the study; The Ethics Committee of Qilu hospital, ShanDong university approved the treatment protocol. All patients undergo scheduled follow-up evaluations for 5 years after transplantation. Clinical, hematological, metabolical evaluations are performed to analyses the effect of the transplant, Patients fitting the inclusion criteria but not agreeing to perform the transplantation are the control group and will received the regular OHA and/or insulin therapy .They are followed in parallel with transplanted patients and will be subjected to the same follow-up management including extensive endocrinological monitoring, diet and exercise program as transplantation patients during the follow-up.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 200 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;
Safety assessment parameter: amylase, hepatic function,renal function,
lipid profile, autoantibody， Quality of life
This study is status unknown, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.
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Shandong University