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Sponsored by: |
Fuzhou General Hospital |
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Information provided by: | Fuzhou General Hospital |
ClinicalTrials.gov Identifier: | NCT00767260 |
There is evidence that the non-immune mediated inflammatory pathways of cell damage occur in vitro in human islets upon hyperglycemia. Autologous stem cell therapies are an emerging set of therapies that show promise with a low side effect profile. we hypothesize that infusion of mononuclear cells from buffy coat obtained from bone marrow may provide multiple signals for regeneration and inflammation-induced lesion recovery of local tissues, of which the effect may be maximized by intra-arterial pancreatic infusion through angiography and combination with hyperbaric oxygen therapy, and simultaneous infusion of large amount of cultured mesenchymal stem cells may promote local regeneration and differentiation, as well as decrease the risk of cell infusion related pancreatitis.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Biological: MSC, BMSC, HOT Biological: BMSC, HOT Biological: BMSC Biological: HOT |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 100 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Autologous Mesenchymal Stem Cell and Bone Marrow Stem Cell Infusion Combined With Hyperbaric Oxygen Therapy
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Biological: MSC, BMSC, HOT
Autologous Mesenchymal Stem Cell and Bone Marrow Stem Cell Infusion Combined With Hyperbaric Oxygen Therapy
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2: Experimental
Autologous Bone Marrow Stem Cell Infusion Combined With Hyperbaric Oxygen Therapy
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Biological: BMSC, HOT
Autologous Bone Marrow Stem Cell Infusion Combined With Hyperbaric Oxygen Therapy
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3: Experimental
Autologous Bone Marrow Stem Cell Infusion alone
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Biological: BMSC
Autologous Bone Marrow Stem Cell Infusion alone
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4: Experimental
Hyperbaric Oxygen Therapy alone
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Biological: HOT
Hyperbaric Oxygen Therapy alone
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Ages Eligible for Study: | 35 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jianming Tan, Professor | 008613375918000 | doctortjm@yahoo.com |
China, FUJIAN | |
Fuzhou General Hospital | Recruiting |
FUZHOU, FUJIAN, China, 350025 |
Principal Investigator: | Jianming Tan, professor | professor |
Responsible Party: | FUZHOU GENERAL HOSPITAL ( FUZHOU GENERAL HOSPITAL ) |
Study ID Numbers: | sc-dm-2008 |
Study First Received: | October 6, 2008 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00767260 |
Health Authority: | China: State Food and Drug Administration |
type 2 diabetes mellitus bone marrow stem cell mesenchymal stem cell hyperbaric oxygen therapy |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |