Trial | NCT01142050  Report issue

Title

Stem Cell Therapy for Type 2 Diabetes Mellitus
A Open Labeled and Self Controlled, Safety/Efficacy Assessed Pilot Study on Transplantation Therapy Using Bone Marrow Mesenchymal Stem Cells for Insulin Resistance of Type 2 Diabetes Mellitus

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    24
The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.
To evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments.
To assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.
Study Started
Aug 31
2010
Primary Completion
Aug 31
2011
Anticipated
Study Completion
Dec 31
2011
Anticipated
Last Update
Jun 11
2010
Estimate

Biological mesenchymal stem cells

1.1st transplantation: after finishing all required examines according to protocol in Day 0, ABM-MSCs are transplanted through pancreas artery percutaneously; 2. 2nd transplantation: after finishing all required examines in Day 7±1, BM-MSCs are transplanted intravenously; 3. 3rd transplantation: after finishing all required examines in Day 14±2, BM-MSCs are transplanted intravenously.

Criteria 

Inclusion Criteria:

Free will taking part in the study and ability to provide written informed consent;
Type 2 diabetes mellitus (as guideline WHO, 1999);
Age 18-75 years old，Male/Female;
19≤Body mass index (BMI)≤30㎏/㎡;
Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％;
Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance;
Not pregnant or nursing;
Negative pregnancy test;
Fertile patients will use effective contraception.

Exclusion Criteria:

Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction);
Active infection requiring treatment;
Unexplained febrile illness;
Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
No Results Posted