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

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ClinicalTrials.gov Identifier: NCT00282685
Recruitment Status : Unknown
Verified November 2007 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : January 27, 2006
Last Update Posted : November 22, 2007
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

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

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Procedure: Intraarterial bone marrow progenitor cell transplantation Phase 1

Detailed Description:

Goal is:

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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)
Study Start Date : October 2005
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Intraarterial bone marrow progenitor cell transplantation
    catheter delivery of stem cells


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

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


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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

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

ClinicalTrials.gov Identifier: NCT00282685     History of Changes
Other Study ID Numbers: 2005-000969-19
RENERVATE
First Posted: January 27, 2006    Key Record Dates
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