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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Intraarterial bone marrow progenitor cell transplantation

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Patients with symmetric peripheral diabetic neuropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Div. of Cardiology and Vascular Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intra-arterial stemcell therapy

Arm Description

Patients were treated with intra-arterial stemcells delivered via catheter examination

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Modified Toronto Clinical Scoring System

Heart rate variability

Full Information

NCT ID

NCT00282685

First Posted

January 25, 2006

Last Updated

October 18, 2021

Sponsor

Johann Wolfgang Goethe University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00282685

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathies

Keywords

Patients with symmetric peripheral diabetic neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intra-arterial stemcell therapy

Arm Type

Experimental

Arm Description

Patients were treated with intra-arterial stemcells delivered via catheter examination

Intervention Type

Procedure

Intervention Name(s)

Intraarterial bone marrow progenitor cell transplantation

Intervention Description

catheter delivery of stem cells

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Modified Toronto Clinical Scoring System

Time Frame

1 year

Title

Heart rate variability

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas M Zeiher, MD

Organizational Affiliation

Div. of Cardiology, University of Frankfurt, Germany

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dirk H Walter, MD

Organizational Affiliation

Div. of Cardiology, University of Frankfurt, Germany

Official's Role

Study Director

Facility Information:

Facility Name

Div. of Cardiology and Vascular Medicine

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Diabetic Neuropathies

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial