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Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Shandong University

Tracking Information
First Submitted Date  ICMJE April 24, 2007
First Posted Date  ICMJE April 25, 2007
Last Update Posted Date April 25, 2007
Study Start Date  ICMJE March 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2007)
Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2007)
  • Safety assessment parameter: amylase, hepatic function,renal function,
  • lipid profile, autoantibody, Quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients
Official Title  ICMJE Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Patients With Type 1 or 2 Diabetes Mellitus-a Phase 1/2 Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Intervention  ICMJE Procedure: Autologous bone marrow mononuclear cell transplantation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: April 24, 2007)
200
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00465478
Other Study ID Numbers  ICMJE QL060308
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Beihua Kong, MD PHD Shandong University
PRS Account Shandong University
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP