Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Patients With Type 1 or 2 Diabetes Mellitus-a Phase 1/2 Study

Sponsors

Lead Sponsor: Shandong University

Source 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.

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.

Overall Status Unknown status
Start Date March 2006
Completion Date March 2014
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;
Secondary Outcome
Measure Time Frame
Safety assessment parameter: amylase, hepatic function,renal function,
lipid profile, autoantibody, Quality of life
Enrollment 200
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Autologous bone marrow mononuclear cell transplantation

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

Gender: All

Minimum Age: 16 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Beihua Kong, MD PHD Study Director Shandong University
Overall Contact

Last Name: Li Chen, MD

Phone: 0086-531-82169408

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Qilu Hospital of Shandong University Li Chen, MD 0086-531-82169408 [email protected] 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 Principal Investigator
Location Countries

China

Verification Date

April 2007

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov