Clinical trial NCT00465478: Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients
Official title: Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Patients With Type 1 or 2 Diabetes Mellitus-a Phase 1/2 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
Bone Marros Mononuclear Cells
Transplantation
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2007-04-25
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes
* Between 16 to 65 years of age
* Requiring daily exogenous insulin injection for the glycaemic control
* With poor β-cell function
* Body mass index (BMI) \< 28

Exclusion Criteria:

* Acute or chronic infections
* Chronic uncompensated organic insufficiency including heart, liver, renal and lung
* Any malignancies, congenital or acquired immunodeficiency
* Hematological diseases or coagulopathy
* Acute or chronic pancreatitis
* History of thoracic or abdominal aorta diseases
* Allergy to iodine
* Pregnancy

Primary outcomes:
measure: Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;
Secondary outcomes:
measure: Safety assessment parameter: amylase, hepatic function,renal function,
measure: lipid profile, autoantibody， Quality of life
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Shandong University
name: Beihua Kong, MD PHD
role: STUDY_DIRECTOR
References: