Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The study is aimed to evaluate the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating selective patients with type 2 Diabetes Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.

Detailed Description
-----------------
To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2 diabetics. According to the intervention and baseline characteristics, patients are divided into 4 arms.

Official Title
-----------------
Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: BMMCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus age 30-70 stable doses of medication for at least 3 months BMI <35 and >18.5 Exclusion Criteria: secondary cause for hyperglycemia pregnancy or nursing positive autoimmune antibody of diabetes severe complication or concurrent diseases active infection or febrile illness allergy to iodine history or signs of aortic aneurysm history or active pancreatic diseases known substance abuse or alcoholism or heavy smoking not suitable for other conditions upon investigators' expertise

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Oral medication treatment<br>type 2 diabetics with only oral medications | |
| Experimental: Oral medication plus BMMCT<br>Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery. | Other: BMMCT<br>* Bone marrow mononuclear cell transplantation via selective catheterization<br>* Other names: Bone marrow mononuclear cell transplantation;|
| No Intervention: Oral medication plus insulin treatment<br>Type 2 diabetics who need insulin therapy with oral medications | |
| Experimental: Oral medication plus insulin plus BMMCT<br>Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery. | Other: BMMCT<br>* Bone marrow mononuclear cell transplantation via selective catheterization<br>* Other names: Bone marrow mononuclear cell transplantation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-peptide |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of medication |  | 1 year | 
| HbA1c |  | 1 year | 
| adverse event |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2; diabetes mellitus; stem cell; safety; efficacy