Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
NCT ID: NCT01322789
Last Updated: 2011-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2008-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intravenous mesenchymal stem cell
This group wil receive 8 intravenous infusions of mesenchymal stem cells. Four infusions 1 week apart and 4 infusions a month apart
Intravenous Mesenchymal stem cell infusion
Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart
Interventions
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Intravenous Mesenchymal stem cell infusion
Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart
Eligibility Criteria
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Inclusion Criteria
* Less than 6 weeks from diagnosis
Exclusion Criteria
* Pregnancy
* Severe psychiatric disorder
* Severe organic impairment (renal, hepatic, cardiac, pulmonary)
* Active infectious disease
* Previous or present neoplastic disease
12 Years
35 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Principal Investigators
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Julio Voltarelli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, School of Medicine of Ribeirão Preto, Brazil
Carlos E Couri, MD, PhD
Role: STUDY_CHAIR
University Hospital, School of Medicine of Ribeirão Preto, Brazil
Locations
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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CNPQ 552266/2005-1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HCFMRPUSP 2
Identifier Type: -
Identifier Source: org_study_id
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