Back to resultsStem Cell Therapy for Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring stem cells;, diabetes mellitus;, treatment.
Eligibility 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.
Sites / Locations
- Armed Police General Hospital, P.R. China
Outcomes
Primary Outcome Measures
ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;
Insulin resistance index indicated by ITT change compared with baseline.
Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline.
Hemoglobin A1c.
Fast blood glucose (FBG) and Postmeal blood glucose (PBG).
C-peptide levels.
Serum Insulin levels.
Secondary Outcome Measures
Serious adverse event frequency and severity
Full Information
NCT ID
NCT01142050
First Posted
June 10, 2010
Last Updated
June 10, 2010
Sponsor
Cellonis Biotechnology Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01142050
Brief Title
Stem Cell Therapy for Type 2 Diabetes Mellitus
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Cellonis Biotechnology Co. Ltd.
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
stem cells;, diabetes mellitus;, treatment.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
mesenchymal stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;
Description
Insulin resistance index indicated by ITT change compared with baseline.
Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline.
Hemoglobin A1c.
Fast blood glucose (FBG) and Postmeal blood glucose (PBG).
C-peptide levels.
Serum Insulin levels.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Serious adverse event frequency and severity
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Armed Police General Hospital, P.R. China
City
Beijing
ZIP/Postal Code
100085
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi X Y, M.D.
12. IPD Sharing Statement
Learn more about this trial
Stem Cell Therapy for Type 2 Diabetes Mellitus
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