Stem Cell Therapy for Type 1 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:
NCT01143168
First received: June 10, 2010
Last updated: June 11, 2010
Last verified: June 2010

June 10, 2010
June 11, 2010
August 2010
August 2011   (final data collection date for primary outcome measure)
Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.
Same as current
Complete list of historical versions of study NCT01143168 on ClinicalTrials.gov Archive Site
Serious adverse event frequency and severity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Stem Cell Therapy for Type 1 Diabetes Mellitus
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

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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Biological: autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells
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.
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. Confirmed diagnosis of type I diabetes for at least 2 years
  3. Insulin-dependent.
  4. Age 18-50 years, Male/Female.
  5. FBG≥7.0 mmol/L, and HbAc1≥7%.
  6. Not pregnant or nursing.
  7. Negative pregnancy test.
  8. Fertile patients will use effective contraception.

Exclusion Criteria:

  1. Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
  2. Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
  3. Active infection requiring treatment.
  4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
Both
18 Years to 50 Years
No
China
 
NCT01143168
Cellonis-CR-1.3
Yes
Cellonis Biotechnology Co. Ltd., Others
Cellonis Biotechnology Co. Ltd.
Not Provided
Principal Investigator: Shi X Y, M.D. Armed Police General Hospital, P. R. China
Cellonis Biotechnology Co. Ltd.
June 2010

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