Clinical trial NCT01677013: Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Type 2 Diabetes Mellitus
Official title: Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2; diabetes mellitus; stem cell; safety; efficacy
Lead sponsor: Peking University Aerospace Center Hospital
Sponsor class: OTHER
First posted: 2012-08-31
Enrollment: 1026
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: C-peptide
timeFrame: 1 year
Secondary outcomes:
measure: reduction of medication
timeFrame: 1 year
measure: HbA1c
timeFrame: 1 year
measure: adverse event
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
state: Beijing
Study officials:
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Yizhong Wang, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Department of Biochemisty, National Cerebral and Cardiovascular Center; Department of Cardiology, China-Japan Friendship Hospital
name: Yuanjie Mao, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Lei Lei, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Danping Meng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Xiyang Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Xiaolin Jia, M.D.
role: STUDY_DIRECTOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Qiuming Jiang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Yufang Li, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Song Dong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Liyan Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Hong Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Mingchao Ding, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Liqin Cui, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Bin Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Xin Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
name: Han Shi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: