NCT00282685

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

3.2 years

First QC Date

January 25, 2006

Last Update Submit

October 18, 2021

Conditions

Diabetic Neuropathies

Keywords

Patients with symmetric peripheral diabetic neuropathy

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (2)

  • Modified Toronto Clinical Scoring System

    1 year

  • Heart rate variability

    1 year

Study Arms (1)

Intra-arterial stemcell therapy

EXPERIMENTAL

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

Procedure: Intraarterial bone marrow progenitor cell transplantation

Interventions

Intraarterial bone marrow progenitor cell transplantationPROCEDURE

catheter delivery of stem cells

Intra-arterial stemcell therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Div. of Cardiology and Vascular Medicine

Frankfurt, 60590, Germany

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Andreas M Zeiher, MD

    Div. of Cardiology, University of Frankfurt, Germany

    PRINCIPAL INVESTIGATOR

  • Dirk H Walter, MD

    Div. of Cardiology, University of Frankfurt, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

October 1, 2005

Primary Completion

December 1, 2008

Study Completion

October 1, 2009

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations

DE(1)