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Stem Cell Therapy for Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01142050
Recruitment Status : Unknown
Verified June 2010 by Cellonis Biotechnology Co. Ltd..
Recruitment status was:  Not yet recruiting
First Posted : June 11, 2010
Last Update Posted : June 11, 2010
Sponsor:
Information provided by:
Cellonis Biotechnology Co. Ltd.

Tracking Information
First Submitted Date  ICMJE June 10, 2010
First Posted Date  ICMJE June 11, 2010
Last Update Posted Date June 11, 2010
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels; [ Time Frame: one year ]
  1. Insulin resistance index indicated by ITT change compared with baseline.
  2. Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline.
  3. Hemoglobin A1c.
  4. Fast blood glucose (FBG) and Postmeal blood glucose (PBG).
  5. C-peptide levels.
  6. Serum Insulin levels.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
Serious adverse event frequency and severity [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Therapy for Type 2 Diabetes Mellitus
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Free will taking part in the study and ability to provide written informed consent;
  2. Type 2 diabetes mellitus (as guideline WHO, 1999);
  3. Age 18-75 years old,Male/Female;
  4. 19≤Body mass index (BMI)≤30㎏/㎡;
  5. Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7%;
  6. Intravenous insulin tolerance test(ITT)indicate patient being insulin resistance;
  7. Not pregnant or nursing;
  8. Negative pregnancy test;
  9. Fertile patients will use effective contraception.

Exclusion Criteria:

  1. Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction);
  2. Active infection requiring treatment;
  3. Unexplained febrile illness;
  4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01142050
Other Study ID Numbers  ICMJE Cellonis-CR-2.3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cellonis Biotechnology Co. Ltd., others
Study Sponsor  ICMJE Cellonis Biotechnology Co. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cellonis Biotechnology Co. Ltd.
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP