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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Information provided by:
Johann Wolfgang Goethe University Hospitals 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
Endpoint Classification: Safety/Efficacy Study
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 Hospitals:

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Hospitals
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

No publications provided Identifier: NCT00282685     History of Changes
Other Study ID Numbers: 2005-000969-19, RENERVATE
Study First Received: January 25, 2006
Last Updated: November 21, 2007
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Diabetic Neuropathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases processed this record on March 01, 2015