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Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

Primary Purpose

Peripheral Vascular Diseases

Status

Unknown status

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

Autologous bone marrow cells

About this trial

This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring Peripheral arterial disease,, blood marrow cells,, therapeutic angiogenesis.

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of third or fourth class of peripheral atherosclerosis Exclusion Criteria: Insuline dependent diabetes Cancer

Sites / Locations

University of NaplesRecruiting

Outcomes

Primary Outcome Measures

Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.

Secondary Outcome Measures

Angiographic and laser doppler measurements after six months from treatment.

Full Information

NCT ID

NCT00306085

First Posted

March 14, 2006

Last Updated

March 21, 2006

Sponsor

University of Naples

1. Study Identification

Unique Protocol Identification Number

NCT00306085

Brief Title

Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

Official Title

Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2006

Overall Recruitment Status

Unknown status

Study Start Date

April 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Naples

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

Peripheral Vascular Diseases

Keywords

Peripheral arterial disease,, blood marrow cells,, therapeutic angiogenesis.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Non-Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Genetic

Intervention Name(s)

Autologous bone marrow cells

Primary Outcome Measure Information:

Title

Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.

Secondary Outcome Measure Information:

Title

Angiographic and laser doppler measurements after six months from treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of third or fourth class of peripheral atherosclerosis Exclusion Criteria: Insuline dependent diabetes Cancer

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heidi Eisele

Phone

+39 081/5665685

heidi.eisele@unina2.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincenzo Sica

Organizational Affiliation

University of Naples

Official's Role

Study Director

Facility Information:

Facility Name

University of Naples

City

Naples

ZIP/Postal Code

80134

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Carmela Corbisiero

Phone

+39081/5665681

marika_corbi@inwind.it

12. IPD Sharing Statement

Citations:

PubMed Identifier

23375329

Citation

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.

Results Reference

derived

PubMed Identifier

20832596

Citation

Cobellis G, Botti C, Taddeo A, Silvestroni A, Lillo S, Da Ponte A, Villa ML, Sica V, Della Bella S. Successful bone marrow transplantation reveals the lack of endothelial progenitor cells mobilization in a patient with critical limb ischemia: a case report. Transplant Proc. 2010 Sep;42(7):2816-20. doi: 10.1016/j.transproceed.2010.04.047.

Results Reference

derived

PubMed Identifier

19050436

Citation

Napoli C, Farzati B, Sica V, Iannuzzi E, Coppola G, Silvestroni A, Balestrieri ML, Florio A, Matarazzo A. Beneficial effects of autologous bone marrow cell infusion and antioxidants/L-arginine in patients with chronic critical limb ischemia. Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):709-18. doi: 10.1097/HJR.0b013e3283193a0f.

Results Reference

derived

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Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

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