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

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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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: BMMCT Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 1026 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus
Study Start Date : May 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: BMMCT
Bone marrow mononuclear cell transplantation via selective catheterization
Other Name: Bone marrow mononuclear cell transplantation

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.
Other: BMMCT
Bone marrow mononuclear cell transplantation via selective catheterization
Other Name: Bone marrow mononuclear cell transplantation




Primary Outcome Measures :
  1. C-peptide [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. reduction of medication [ Time Frame: 1 year ]
  2. HbA1c [ Time Frame: 1 year ]
  3. adverse event [ Time Frame: 1 year ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677013


Locations
China, Beijing
Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
Beijing, Beijing, China, 100049
Sponsors and Collaborators
Peking University Aerospace Centre Hospital
Investigators
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

Responsible Party: Lei Lei, MD, Endocrinologist, Peking University Aerospace Centre Hospital
ClinicalTrials.gov Identifier: NCT01677013     History of Changes
Other Study ID Numbers: PUACH-721002
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

Keywords provided by Lei Lei, MD, Peking University Aerospace Centre Hospital:
Type 2; diabetes mellitus; stem cell; safety; efficacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs