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

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00282685
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 48
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• 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: Oct 1, 2005
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intra-arterial stemcell therapy Patients were treated with intra-arterial stemcells delivered via catheter examination	Procedure: Intraarterial bone marrow progenitor cell transplantation; catheter delivery of stem cells

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Modified Toronto Clinical Scoring System [1 year]

2. Heart rate variability [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Div. of Cardiology and Vascular Medicine	Frankfurt		Germany	60590

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: A. M. Zeiher, Prof. Dr. med., Johann Wolfgang Goethe University Hospital
• ClinicalTrials.gov Identifier: NCT00282685
• Other Study ID Numbers: 2005-000969-19; RENERVATE
• First Posted: Jan 27, 2006
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by A. M. Zeiher, Prof. Dr. med., Johann Wolfgang Goethe University Hospital: Patients with symmetric peripheral diabetic neuropathy
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies

Study Results

No Results Posted as of Oct 26, 2021