Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465478
Status:
UNKNOWN
Last Update Posted:
2007-04-25
First Post:
2007-04-24
Brief Title:
Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients
Sponsor:
Shandong University
Organization:
Shandong University
Study Overview
Official Title:
Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Patients With Type 1 or 2 Diabetes Mellitus-a Phase 12 Study
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None