Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Shandong University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shandong University
ClinicalTrials.gov Identifier:
NCT00465478
First received: April 24, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Procedure: Autologous bone marrow mononuclear cell transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shandong University:

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

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

Estimated Enrollment: 200
Study Start Date: March 2006
Estimated Study Completion Date: March 2014
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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465478

Contacts
Contact: Li Chen, MD 0086-531-82169408 chenli3@medmail.com.cn
Contact: Xingli Wang, MD PhD 832-355-9939 xlwang@bcm.tmc.edu

Locations
China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Li Chen, MD    0086-531-82169408    chenli3@medmai.com.cn   
Contact: Xingli Wang, MD,PhD    832-355-9939    xlwang@bcm.tmc.edu   
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
Investigators
Study Director: Beihua Kong, MD PHD Shandong University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00465478     History of Changes
Other Study ID Numbers: QL060308
Study First Received: April 24, 2007
Last Updated: April 24, 2007
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Diabetes Mellitus
Bone Marros Mononuclear Cells
Transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014