NCT01677013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,026

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started May 2011

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

4 years

First QC Date

August 29, 2012

Last Update Submit

September 30, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • C-peptide

    1 year

Secondary Outcomes (3)

  • reduction of medication

    1 year

  • HbA1c

    1 year

  • adverse event

    1 year

Study Arms (4)

Oral medication treatment

NO INTERVENTION

type 2 diabetics with only oral medications

Oral medication plus BMMCT

EXPERIMENTAL

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

Other: BMMCT

Oral medication plus insulin treatment

NO INTERVENTION

Type 2 diabetics who need insulin therapy with oral medications

Oral medication plus insulin plus BMMCT

EXPERIMENTAL

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

Other: BMMCT

Interventions

BMMCTOTHER

Bone marrow mononuclear cell transplantation via selective catheterization

Also known as: Bone marrow mononuclear cell transplantation
Oral medication plus BMMCTOral medication plus insulin plus BMMCT

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • age 30-70
  • stable doses of medication for at least 3 months
  • BMI \<35 and \>18.5

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

Beijing, Beijing Municipality, 100049, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Yizhong Wang, M.D., Ph.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    STUDY CHAIR

  • Yuanjie Mao, M.D., Ph.D.

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

    STUDY DIRECTOR

  • Lei Lei, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Danping Meng, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Xiyang Zhang, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Xiaolin Jia, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    STUDY DIRECTOR

  • Qiuming Jiang, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Yufang Li, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Song Dong, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Liyan Yang, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Hong Wang, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Mingchao Ding, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Liqin Cui, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Bin Wang, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Xin Lin, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

  • Han Shi, M.D.

    Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endocrinologist

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

May 1, 2011

Primary Completion

May 1, 2015

Study Completion

July 1, 2017

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

CN(1)