Status:
COMPLETED
Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Treatment of patients with diabetic neuropathy by intraarterial progenitor cell transplantation.
Detailed Description
Goal is: Stimulation of angiogenesis and induction of vasa nervorum in order to improve nerve function
Eligibility Criteria
Inclusion
- Patients with distal symmetrical diabetic neuropathy of the legs
- Type 1 or Type 2 Diabetes
- Stable Glucose control over last 3 months (Hba1c \<7.5)
- Written informed consent
Exclusion
- Patients with peripheral arterial disease (ABI \<0.9)
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00282685
Start Date
October 1 2005
End Date
October 1 2009
Last Update
October 26 2021
Active Locations (1)
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1
Div. of Cardiology and Vascular Medicine
Frankfurt, Germany, 60590