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

Johann Wolfgang Goethe University Hospital

Status and phase: Completed; Phase 1

Conditions: Diabetic Neuropathies

Treatments: Procedure: Intraarterial bone marrow progenitor cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00282685

2005-000969-19

RENERVATE

Details and patient eligibility

About

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

Full description

Goal is:

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

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Intra-arterial stemcell therapy

Experimental group

Description:

Patients were treated with intra-arterial stemcells delivered via catheter examination

Treatment:

Procedure: Intraarterial bone marrow progenitor cell transplantation