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NCT00282685 Clinical Trial

Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy

Diabetic Neuropathies Clinical Trial

Official title:
(Restoration of Nerve Functions by Intra-arterial Transplantation of Bone Marrow Progenitor Cells in Patients With Diabetic Poly Neuropathy (PNP)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00282685
Other study ID # 2005-000969-19
Secondary ID RENERVATE
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2005
Est. completion date October 2009

Study information
Verified date October 2021
Source Johann Wolfgang Goethe University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Treatment of patients with diabetic neuropathy by intraarterial progenitor cell transplantation.

Description:

Goal is: Stimulation of angiogenesis and induction of vasa nervorum in order to improve nerve function

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date October 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Intraarterial bone marrow progenitor cell transplantation
catheter delivery of stem cells

Locations
Country Name City State
Germany Div. of Cardiology and Vascular Medicine Frankfurt

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of neurological score: modified NIS(LL)+7 1 year
Secondary Modified Toronto Clinical Scoring System 1 year
Secondary Heart rate variability 1 year
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