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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014