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Stem Cell Therapy for Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01143168
Recruitment Status : Unknown
Verified June 2010 by Cellonis Biotechnology Co. Ltd..
Recruitment status was:  Not yet recruiting
First Posted : June 14, 2010
Last Update Posted : June 14, 2010
Sponsor:
Information provided by:
Cellonis Biotechnology Co. Ltd.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Biological: autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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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.

Outcome Measures
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Primary Outcome Measures :
  1. Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels. [ Time Frame: 1 year ]
    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 :
  1. Serious adverse event frequency and severity [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143168


Locations
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China
Armed Police General Hospital, P. R. China
Beijing, China, 100085
Sponsors and Collaborators
Cellonis Biotechnology Co. Ltd.
Investigators
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Principal Investigator: Shi X Y, M.D. Armed Police General Hospital, P. R. China
More Information
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Responsible Party: Cellonis Biotechnology Co. Ltd., Others
ClinicalTrials.gov Identifier: NCT01143168    
Other Study ID Numbers: Cellonis-CR-1.3
First Posted: June 14, 2010    Key Record Dates
Last Update Posted: June 14, 2010
Last Verified: June 2010
Keywords provided by Cellonis Biotechnology Co. Ltd.:
stem cells;
diabetes mellitus;
treatment.
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases