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NCT01677013 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01677013
Other study ID # PUACH-721002
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 29, 2012
Last updated September 30, 2017
Start date May 2011
Est. completion date July 2017

Study information
Verified date September 2017
Source Peking University Aerospace Centre Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1026
Est. completion date July 2017
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• BMMCT
Bone marrow mononuclear cell transplantation via selective catheterization

Locations
Country Name City State
China Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University Aerospace Centre Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary C-peptide 1 year
Secondary reduction of medication 1 year
Secondary HbA1c 1 year
Secondary adverse event 1 year
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