Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00282685
Other study ID # 2005-000969-19
Secondary ID RENERVATE
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2005
Est. completion date October 2009

Study information

Verified date October 2021
Source Johann Wolfgang Goethe University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date October 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Div. of Cardiology and Vascular Medicine Frankfurt

Sponsors (1)

Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of neurological score: modified NIS(LL)+7 1 year
Secondary Modified Toronto Clinical Scoring System 1 year
Secondary Heart rate variability 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05683106 - Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy N/A
Withdrawn NCT04106050 - Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy Phase 1
Completed NCT04088929 - The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy Phase 2
Completed NCT01939366 - Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves Phase 2
Withdrawn NCT00815932 - The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy N/A
Completed NCT01926522 - Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients N/A
Not yet recruiting NCT01180608 - Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain N/A
Completed NCT00380913 - Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy Phase 4
Completed NCT00760955 - Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy Phase 2
Terminated NCT00756041 - Safety Study of TAK-128 in Subjects With Diabetic Peripheral Neuropathy Phase 2
Completed NCT05255497 - The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy N/A
Completed NCT06061237 - Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy N/A
Terminated NCT02915263 - The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes Phase 2
Enrolling by invitation NCT05043636 - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed NCT06373809 - Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy Early Phase 1
Completed NCT05968131 - Comparative Effects of Proprioceptive Training and Routine Physical Therapy on Diabetic Peripheral Neuropathy N/A
Completed NCT00135109 - Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy Phase 3
Completed NCT06292962 - Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain N/A
Completed NCT05058807 - Effects of Whole Body Vibration in Diabetic Peripheral Neuropathy . N/A
Not yet recruiting NCT04092140 - Neuromuscular Ultrasound in Correlation to Neurophysiological Findings