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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01677013
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Lei Lei, MD, Peking University Aerospace Centre Hospital

Tracking Information
First Submitted Date  ICMJE August 29, 2012
First Posted Date  ICMJE August 31, 2012
Last Update Posted Date October 3, 2017
Study Start Date  ICMJE May 2011
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2012)
C-peptide [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01677013 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2012)
  • reduction of medication [ Time Frame: 1 year ]
  • HbA1c [ Time Frame: 1 year ]
  • adverse event [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Type 2 Diabetes Mellitus
Official Title  ICMJE Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE Other: BMMCT
Bone marrow mononuclear cell transplantation via selective catheterization
Other Name: Bone marrow mononuclear cell transplantation
Study Arms  ICMJE
  • No Intervention: Oral medication treatment
    type 2 diabetics with only oral medications
  • Experimental: Oral medication plus BMMCT
    Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.
    Intervention: Other: BMMCT
  • No Intervention: Oral medication plus insulin treatment
    Type 2 diabetics who need insulin therapy with oral medications
  • Experimental: Oral medication plus insulin plus BMMCT
    Collect mononuclear cells from bone marrow aspiration, administer to pancreas via selective catheterization to splenic artery.
    Intervention: Other: BMMCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2017)
1026
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2012)
500
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01677013
Other Study ID Numbers  ICMJE PUACH-721002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lei Lei, MD, Peking University Aerospace Centre Hospital
Study Sponsor  ICMJE Peking University Aerospace Centre Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yizhong Wang, M.D., Ph.D. Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
Study Director: Yuanjie Mao, M.D., Ph.D. Department of Biochemisty, National Cerebral and Cardiovascular Center; Department of Cardiology, China-Japan Friendship Hospital
Principal Investigator: 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
Study Director: Xiaolin Jia, M.D. Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
Principal Investigator: 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
PRS Account Peking University Aerospace Centre Hospital
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP