Autologous Bone Marrow Cell Treatment in Peripheral Ather... | NCT00306085

Studies
Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

NCT00306085

Sponsor

University of Naples

Status

Unknown status

Last Update Posted

Mar 22, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Peripheral Vascular Diseases

Interventions

Autologous bone marrow cells

Countries

Italy

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

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Mar 14, 2006

First Submission Date that Met QC Criteria

Mar 21, 2006

First Posted Date

Mar 22, 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

Mar 21, 2006

Last Update Posted Date

Mar 22, 2006Estimated

Description Module

Brief Summary

Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic limbs has been shown to improve collateral vessel formation. In the present study the safety and feasibility of autologous blood mononuclear cells implantation will be investigated in patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in the ankle-brachial pressure index (ABI:>0.1), ischemic ulcers and angiography as well as laser doppler flow will be evaluated until six months.

Detailed Description

Not provided

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

Name	Type	Description	Arm Group Labels	Other Names
Autologous bone marrow cells	Genetic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.

Secondary Outcomes

Measure	Description	Time Frame
Angiographic and laser doppler measurements after six months from treatment.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria:

Insuline dependent diabetes
Cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Heidi Eisele	Contact	+39 081/5665685		heidi.eisele@unina2.it

Overall Officials

Name	Affiliation	Role
Vincenzo Sica	University of Naples	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Naples	Recruiting	Naples		80134	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23375329	Derived	Maione C, Botti C, Coppola CA, Silvestroni C, Lillo S, Schiavone V, Sica G, Sica V, Kumar V, Cobellis G. Effect of autologous transplantation of bone marrow cells concentrated with the MarrowXpress system in patients with critical limb ischemia. Transplant Proc. 2013 Jan-Feb;45(1):402-6. doi: 10.1016/j.transproceed.2012.10.031.
20832596

ID	Term
D016491	Peripheral Vascular Diseases
D058729	Peripheral Arterial Disease

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D050197	Atherosclerosis
D001161	Arteriosclerosis