Back to resultsStem Cell Therapy for Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 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.
- Confirmed diagnosis of type I diabetes for at least 2 years
- Insulin-dependent.
- Age 18-50 years, Male/Female.
- FBG≥7.0 mmol/L, and HbAc1≥7％.
- Not pregnant or nursing.
- Negative pregnancy test.
- Fertile patients will use effective contraception.
Exclusion Criteria:
- Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
- Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
- Active infection requiring treatment.
- 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
Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.
Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.
Secondary Outcome Measures
Serious adverse event frequency and severity
Full Information
NCT ID
NCT01143168
First Posted
June 10, 2010
Last Updated
June 11, 2010
Sponsor
Cellonis Biotechnology Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01143168
Brief Title
Stem Cell Therapy for Type 1 Diabetes Mellitus
Official Title
A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus
Detailed Description
To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 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
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells
Intervention Description
First Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 7±1, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines on Day 14±2, BM-MNCs + UCMSCs are transplanted intravenously.
Primary Outcome Measure Information:
Title
Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.
Description
Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Serious adverse event frequency and severity
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Free will taking part in the study and ability to provide written informed consent.
Confirmed diagnosis of type I diabetes for at least 2 years
Insulin-dependent.
Age 18-50 years, Male/Female.
FBG≥7.0 mmol/L, and HbAc1≥7％.
Not pregnant or nursing.
Negative pregnancy test.
Fertile patients will use effective contraception.
Exclusion Criteria:
Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
Active infection requiring treatment.
Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi X Y, M.D.
Organizational Affiliation
Armed Police General Hospital, P. R. China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Police General Hospital, P. R. China
City
Beijing
ZIP/Postal Code
100085
Country
China
12. IPD Sharing Statement
Learn more about this trial
Stem Cell Therapy for Type 1 Diabetes Mellitus
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