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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

BMMCT

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2; diabetes mellitus; stem cell; safety; efficacy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Oral medication treatment

Oral medication plus BMMCT

Oral medication plus insulin treatment

Oral medication plus insulin plus BMMCT

Arm Description

type 2 diabetics with only oral medications

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

Type 2 diabetics who need insulin therapy with oral medications

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

Outcomes

Primary Outcome Measures

C-peptide

Secondary Outcome Measures

reduction of medication

HbA1c

adverse event

Full Information

NCT ID

NCT01677013

First Posted

August 29, 2012

Last Updated

September 30, 2017

Sponsor

Peking University Aerospace Centre Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01677013

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Aerospace Centre Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Type 2 Diabetes Mellitus

Keywords

Type 2; diabetes mellitus; stem cell; safety; efficacy

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

1026 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral medication treatment

Arm Type

No Intervention

Arm Description

type 2 diabetics with only oral medications

Arm Title

Oral medication plus BMMCT

Arm Type

Experimental

Arm Description

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

Arm Title

Oral medication plus insulin treatment

Arm Type

No Intervention

Arm Description

Type 2 diabetics who need insulin therapy with oral medications

Arm Title

Oral medication plus insulin plus BMMCT

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

BMMCT

Other Intervention Name(s)

Bone marrow mononuclear cell transplantation

Intervention Description

Bone marrow mononuclear cell transplantation via selective catheterization

Primary Outcome Measure Information:

Title

C-peptide

Time Frame

1 year

Secondary Outcome Measure Information:

Title

reduction of medication

Time Frame

1 year

Title

HbA1c

Time Frame

1 year

Title

adverse event

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yizhong Wang, M.D., Ph.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Yuanjie Mao, M.D., Ph.D.

Organizational Affiliation

Department of Biochemisty, National Cerebral and Cardiovascular Center; Department of Cardiology, China-Japan Friendship Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Lei Lei, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Danping Meng, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiyang Zhang, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiaolin Jia, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Qiuming Jiang, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yufang Li, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Song Dong, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Liyan Yang, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hong Wang, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mingchao Ding, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Liqin Cui, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bin Wang, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xin Lin, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Han Shi, M.D.

Organizational Affiliation

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100049

Country

China

12. IPD Sharing Statement

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