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Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00465478
Recruitment Status : Unknown
Verified April 2007 by Shandong University.
Recruitment status was:  Recruiting
First Posted : April 25, 2007
Last Update Posted : April 25, 2007
Information provided by:
Shandong University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Procedure: Autologous bone marrow mononuclear cell transplantation Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Patients With Type 1 or 2 Diabetes Mellitus-a Phase 1/2 Study
Study Start Date : March 2006
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;

Secondary Outcome Measures :
  1. Safety assessment parameter: amylase, hepatic function,renal function,
  2. lipid profile, autoantibody, Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00465478

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Contact: Li Chen, MD 0086-531-82169408
Contact: Xingli Wang, MD PhD 832-355-9939

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China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Li Chen, MD    0086-531-82169408   
Contact: Xingli Wang, MD,PhD    832-355-9939   
Principal Investigator: Li Chen, MD         
Principal Investigator: Xingli Wang, MD,PhD         
Principal Investigator: Weikai Hou, MD         
Principal Investigator: Jianjun Dong, MD         
Principal Investigator: Kuanxiao Tang, MD,PhD         
Principal Investigator: Xinguo Hou, MD         
Principal Investigator: Lei Sun, MD         
Sponsors and Collaborators
Shandong University
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Study Director: Beihua Kong, MD PHD Shandong University
Additional Information:
Layout table for additonal information Identifier: NCT00465478    
Other Study ID Numbers: QL060308
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: April 25, 2007
Last Verified: April 2007
Keywords provided by Shandong University:
Diabetes Mellitus
Bone Marros Mononuclear Cells
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases