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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
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00282685
First received: January 25, 2006
Last updated: November 21, 2007
Last verified: November 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282685

Contacts
Contact: Dirk H Walter, MD +49 69 6301 ext 5932 d.walter@em.uni-frankfurt.de

Locations
Germany
Div. of Cardiology and Vascular Medicine Recruiting
Frankfurt, Germany, 60590
Contact: Dirk H Walter, MD     +49 69 6301 ext 5932     d.walter@em.uni-frankfurt.de    
Contact: Andreas M Zeiher, MD     +49 69 6301 ext 5789     zeiher@em.uni-frankfurt.de    
Principal Investigator: Andreas M Zeiher, MD            
Sub-Investigator: Dirk H Walter, MD            
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
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

ClinicalTrials.gov 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
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 22, 2013