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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
History of Changes
  Purpose

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


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Biological: autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Serious adverse event frequency and severity [ Time Frame: 1 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: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 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. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143168

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

No publications provided

Responsible Party: Cellonis Biotechnology Co. Ltd., Others
ClinicalTrials.gov Identifier: NCT01143168     History of Changes
Other Study ID Numbers: Cellonis-CR-1.3
Study First Received: June 10, 2010
Last Updated: June 11, 2010
Health Authority: China: Ethics Committe

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013