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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Information provided by:
Johann Wolfgang Goethe University Hospital Identifier:
First received: January 25, 2006
Last updated: November 21, 2007
Last verified: November 2007
Treatment of patients with diabetic neuropathy by intraarterial progenitor cell transplantation.

Condition Intervention Phase
Diabetic Neuropathies
Procedure: Intraarterial bone marrow progenitor cell transplantation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: (Restoration of Nerve Functions by Intra-Arterial Transplantation of Bone Marrow Progenitor Cells in Patients With Diabetic Poly Neuropathy (PNP)

Resource links provided by NLM:

Further study details as provided by Johann Wolfgang Goethe University Hospital:

Primary Outcome Measures:
  • Improvement of neurological score: modified NIS(LL)+7 [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Modified Toronto Clinical Scoring System [ Time Frame: 1 year ]
  • Heart rate variability [ Time Frame: 1 year ]

Estimated Enrollment: 20
Study Start Date: October 2005
Estimated Study Completion Date: October 2008
Intervention Details:
    Procedure: Intraarterial bone marrow progenitor cell transplantation
    catheter delivery of stem cells
Detailed Description:

Goal is:

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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00282685

Contact: Dirk H Walter, MD +49 69 6301 ext 5932

Div. of Cardiology and Vascular Medicine Recruiting
Frankfurt, Germany, 60590
Contact: Dirk H Walter, MD    +49 69 6301 ext 5932   
Contact: Andreas M Zeiher, MD    +49 69 6301 ext 5789   
Principal Investigator: Andreas M Zeiher, MD         
Sub-Investigator: Dirk H Walter, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Principal Investigator: Andreas M Zeiher, MD Div. of Cardiology, University of Frankfurt, Germany
Study Director: Dirk H Walter, MD Div. of Cardiology, University of Frankfurt, Germany
  More Information Identifier: NCT00282685     History of Changes
Other Study ID Numbers: 2005-000969-19
Study First Received: January 25, 2006
Last Updated: November 21, 2007

Keywords provided by Johann Wolfgang Goethe University Hospital:
Patients with symmetric peripheral diabetic neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases processed this record on May 24, 2017