Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00465478
• Other study ID #: QL060308
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 24, 2007
• Last updated: April 24, 2007
• Start date: March 2006
• Est. completion date: March 2014

Study information

• Verified date: April 2007
• Source: Shandong University
• Contact: Li Chen, MD
• Phone: 0086-531-82169408
• Email: chenli3[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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 ß-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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Procedure:
• Autologous bone marrow mononuclear cell transplantation

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;
Secondary	Safety assessment parameter: amylase, hepatic function,renal function,
Secondary	lipid profile, autoantibody, Quality of life

External Links

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