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

This study is currently recruiting participants.
Verified August 2012 by Peking University Aerospace Centre Hospital
Sponsor:
Information provided by (Responsible Party):
Lei Lei, MD, Peking University Aerospace Centre Hospital
ClinicalTrials.gov Identifier:
NCT01677013
First received: August 29, 2012
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
 Other: BMMCT
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking University Aerospace Centre Hospital:

Primary Outcome Measures:
  • C-peptide [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduction of medication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • adverse event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: May 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677013

Contacts
Contact: Lei Lei, M.D. +86-10-59971870 leileihospital@gmail.com

Locations
China, Beijing
Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital Recruiting
Beijing, Beijing, China, 100049
Principal Investigator: Lei Lei, M.D.            
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
  More Information

No publications provided

Responsible Party: Lei Lei, MD, Endocrinologist, Peking University Aerospace Centre Hospital
ClinicalTrials.gov Identifier: NCT01677013     History of Changes
Other Study ID Numbers: PUACH-721002
Study First Received: August 29, 2012
Last Updated: August 30, 2012
Health Authority: China: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on June 18, 2013