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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1026 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral medication treatment

type 2 diabetics with only oral medications

Group Type NO_INTERVENTION

No interventions assigned to this group

Oral medication plus BMMCT

Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.

Group Type EXPERIMENTAL

BMMCT

Intervention Type OTHER

Bone marrow mononuclear cell transplantation via selective catheterization

Oral medication plus insulin treatment

Type 2 diabetics who need insulin therapy with oral medications

Group Type NO_INTERVENTION

No interventions assigned to this group

Oral medication plus insulin plus BMMCT

Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.

Group Type EXPERIMENTAL

BMMCT

Intervention Type OTHER

Bone marrow mononuclear cell transplantation via selective catheterization

Interventions

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BMMCT

Bone marrow mononuclear cell transplantation via selective catheterization

Intervention Type OTHER

Other Intervention Names

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Bone marrow mononuclear cell transplantation

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Lei Lei, MD

Endocrinologist

Responsibility Role PRINCIPAL_INVESTIGATOR