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Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Autologous bone marrow mononuclear cell transplantation

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Bone Marros Mononuclear Cells, Transplantation

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Qilu Hospital of Shandong UniversityRecruiting

Outcomes

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

Full Information

NCT ID

NCT00465478

First Posted

April 24, 2007

Last Updated

April 24, 2007

Sponsor

Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT00465478

Brief Title

Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Unknown status

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Shandong University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Bone Marros Mononuclear Cells, Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Autologous bone marrow mononuclear cell transplantation

Primary Outcome Measure Information:

Title

Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;

Secondary Outcome Measure Information:

Title

Safety assessment parameter: amylase, hepatic function,renal function,

Title

lipid profile, autoantibody， Quality of life

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Chen, MD

Phone

0086-531-82169408

chenli3@medmail.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xingli Wang, MD PhD

Phone

832-355-9939

xlwang@bcm.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beihua Kong, MD PHD

Organizational Affiliation

Shandong University

Official's Role

Study Director

Facility Information:

Facility Name

Qilu Hospital of Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Chen, MD

Phone

0086-531-82169408

chenli3@medmai.com.cn

First Name & Middle Initial & Last Name & Degree

Xingli Wang, MD,PhD

Phone

832-355-9939

xlwang@bcm.tmc.edu

First Name & Middle Initial & Last Name & Degree

Li Chen, MD

First Name & Middle Initial & Last Name & Degree

Xingli Wang, MD,PhD

First Name & Middle Initial & Last Name & Degree

Weikai Hou, MD

First Name & Middle Initial & Last Name & Degree

Jianjun Dong, MD

First Name & Middle Initial & Last Name & Degree

Kuanxiao Tang, MD,PhD

First Name & Middle Initial & Last Name & Degree

Xinguo Hou, MD

First Name & Middle Initial & Last Name & Degree

Lei Sun, MD

12. IPD Sharing Statement

Links:

URL

http://www.qiluhospital.com

Description

Related Info

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Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

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