Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy
NCT ID: NCT00282685
Last Updated: 2021-10-26
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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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2005-10-31
2009-10-31
Brief Summary
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Detailed Description
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Stimulation of angiogenesis and induction of vasa nervorum in order to improve nerve function
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intra-arterial stemcell therapy
Patients were treated with intra-arterial stemcells delivered via catheter examination
Intraarterial bone marrow progenitor cell transplantation
catheter delivery of stem cells
Interventions
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Intraarterial bone marrow progenitor cell transplantation
catheter delivery of stem cells
Eligibility Criteria
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Inclusion Criteria
* Type 1 or Type 2 Diabetes
* Stable Glucose control over last 3 months (Hba1c \<7.5)
* Written informed consent
Exclusion Criteria
* Neuropathy of other origin
* Myopathy
* Asymmetrical neuropathy
* Active infection oder fever
* Chronic inflammatory disease (z.B M. Crohn, Rheumatoid Arthritis)
* HIV or hepatitis
* Neoplastic disease without complete remission within last 5 y
* Stroke or myocardial infarction within last 3 months
* Renal failure (creatinine \> 2 mg/dl)
* Liver disease (GOT \> 2 upper limit or spontaneous INR \> 1,5).
* Anemia (hemoglobine \< 8.5 mg/dl)
* Platelets \<100.000/µl
* HbA1c \>7,5 %
* Allergies to Aspirin, Clopidogrel, Heparin
* Bleeding disorder
* Surgery or trauma within the last 2 months
* Pregnancy
* Mental retardation
* Participation in another study within 30 days
18 Years
80 Years
ALL
No
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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A. M. Zeiher
Prof. Dr. med.
Principal Investigators
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Andreas M Zeiher, MD
Role: PRINCIPAL_INVESTIGATOR
Div. of Cardiology, University of Frankfurt, Germany
Dirk H Walter, MD
Role: STUDY_DIRECTOR
Div. of Cardiology, University of Frankfurt, Germany
Locations
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Div. of Cardiology and Vascular Medicine
Frankfurt, , Germany
Countries
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Other Identifiers
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RENERVATE
Identifier Type: -
Identifier Source: secondary_id
2005-000969-19
Identifier Type: -
Identifier Source: org_study_id