Safety and Feasibility Study of Autologous Progenitor Cel... | NCT00282685

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

NCT00282685

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Oct 26, 2021Actual

Enrollment

7Actual

Phase

Phase 1

Conditions

Diabetic Neuropathies

Interventions

Intraarterial bone marrow progenitor cell transplantation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RENERVATE

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jan 25, 2006

First Submission Date that Met QC Criteria

Jan 25, 2006

First Posted Date

Jan 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2021

Last Update Posted Date

Oct 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intra-arterial stemcell therapy	Experimental	Patients were treated with intra-arterial stemcells delivered via catheter examination	Procedure: Intraarterial bone marrow progenitor cell transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraarterial bone marrow progenitor cell transplantation	Procedure	catheter delivery of stem cells	Intra-arterial stemcell therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of neurological score: modified NIS(LL)+7		1 year

Secondary Outcomes

Measure	Description	Time Frame
Modified Toronto Clinical Scoring System		1 year
Heart rate variability		1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Div. of Cardiology and Vascular Medicine		Frankfurt		60590	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003929	Diabetic Neuropathies

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided