Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2006 by University of Naples.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Naples

ClinicalTrials.gov Identifier:

NCT00306085

First received: March 14, 2006

Last updated: March 21, 2006

Last verified: March 2006

History of Changes

Purpose

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.

Condition	Intervention	Phase
Peripheral Vascular Diseases	Genetic: Autologous bone marrow cells	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Autologous Bone Marrow Cell Treatment in Patients With Peripheral Atherosclerosis

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Further study details as provided by University of Naples:

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.

Estimated Enrollment:	20
Study Start Date:	April 2005
Estimated Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	45 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria:

Insuline dependent diabetes
Cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306085

Contacts

Contact: Heidi Eisele

+39 081/5665685

heidi.eisele@unina2.it

Locations

Italy
University of Naples	Recruiting
Naples, Italy, 80134
Contact: Maria Carmela Corbisiero +39081/5665681 marika_corbi@inwind.it

Sponsors and Collaborators

University of Naples

Investigators

Study Director:

Vincenzo Sica

University of Naples

More Information

No publications provided by University of Naples

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00306085 History of Changes
Other Study ID Numbers:	1
Study First Received:	March 14, 2006
Last Updated:	March 21, 2006
Health Authority:	Italy: Ministry of Health

Keywords provided by University of Naples:

Peripheral arterial disease,
blood marrow cells,
therapeutic angiogenesis.

Additional relevant MeSH terms:

Atherosclerosis
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease

Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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