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

This study is currently recruiting participants.

Verified by Johann Wolfgang Goethe University Hospitals, November 2007

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00282685

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 I

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	(Restoration of Nerve Functions by Intra-Arterial Transplantation of Bone Marrow Progenitor Cells in Patients With Diabetic Poly Neuropathy (PNP)

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:

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

Study ID Numbers:	2005-000969-19, RENERVATE
Study First Received:	January 25, 2006
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00282685
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Johann Wolfgang Goethe University Hospitals:

Patients with symmetric peripheral diabetic neuropathy

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Polyneuropathies
Endocrine System Diseases
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009