Stem Cell Therapy for Type 1 Diabetes Mellitus

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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