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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282685
First Posted: January 27, 2006
Last Update Posted: November 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hospital
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

ClinicalTrials.gov Identifier: NCT00282685     History of Changes
Other Study ID Numbers: 2005-000969-19
RENERVATE
First Submitted: January 25, 2006
First Posted: January 27, 2006
Last Update Posted: November 22, 2007
Last Verified: November 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