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Stem Cell Therapy for Type 2 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Cellonis Biotechnology Co. Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Cellonis Biotechnology Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01142050
First received: June 10, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted

June 10, 2010
June 10, 2010
August 2010
August 2011   (final data collection date for primary outcome measure)
ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels; [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  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.
Same as current
No Changes Posted
Serious adverse event frequency and severity [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
24
December 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
China
 
NCT01142050
Cellonis-CR-2.3
Not Provided
Cellonis Biotechnology Co. Ltd., others
Cellonis Biotechnology Co. Ltd.
Not Provided
Not Provided
Cellonis Biotechnology Co. Ltd.
June 2010

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