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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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Biological: mesenchymal stem cells
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cellonis Biotechnology Co. Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Serious adverse event frequency and severity [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142050

Locations
China
Armed Police General Hospital, P.R. China Not yet recruiting
Beijing, China, 100085
Principal Investigator: Shi X Y, M.D.            
Sponsors and Collaborators
Cellonis Biotechnology Co. Ltd.
  More Information

No publications provided

Responsible Party: Cellonis Biotechnology Co. Ltd., others
ClinicalTrials.gov Identifier: NCT01142050     History of Changes
Other Study ID Numbers: Cellonis-CR-2.3
Study First Received: June 10, 2010
Last Updated: June 10, 2010
Health Authority: China: Ethics Committee

Keywords provided by Cellonis Biotechnology Co. Ltd.:
stem cells;
diabetes mellitus;
treatment.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013