We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stem Cell Therapy for Type 1 Diabetes Mellitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Cellonis Biotechnology Co. Ltd..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01143168
First Posted: June 14, 2010
Last Update Posted: June 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cellonis Biotechnology Co. Ltd.
  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
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

Resource links provided by NLM:


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 ]
    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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
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

Responsible Party: Cellonis Biotechnology Co. Ltd., Others
ClinicalTrials.gov Identifier: NCT01143168     History of Changes
Other Study ID Numbers: Cellonis-CR-1.3
First Submitted: June 10, 2010
First Posted: June 14, 2010
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:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases