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OpenTrials
Completed

NCT Number: NCT00282685

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

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

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Div. of Cardiology and Vascular Medicine

Frankfurt, 60590, Germany

About this study

Goal is:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraarterial bone marrow progenitor cell transplantation

Procedure

catheter delivery of stem cells

Primary outcomes

  1. Improvement of neurological score: modified NIS(LL)+7

    Time frame: 1 year

Secondary outcomes

  1. Modified Toronto Clinical Scoring System

    Time frame: 1 year

  2. Heart rate variability

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

(Restoration of Nerve Functions by Intra-arterial Transplantation of Bone Marrow Progenitor Cells in Patients With Diabetic Poly Neuropathy (PNP)

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jan 27, 2006
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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