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Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

NCT ID: NCT00306085

Last Updated: 2006-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-04-30

Brief Summary

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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

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Conditions

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Peripheral Vascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Autologous bone marrow cells

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria

* Insuline dependent diabetes
* Cancer
Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Naples

OTHER

Sponsor Role lead

Principal Investigators

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Vincenzo Sica

Role: STUDY_DIRECTOR

University of Naples

Locations

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University of Naples

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Heidi Eisele

Role: CONTACT

[email protected]
+39 081/5665685

Facility Contacts

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Maria Carmela Corbisiero

Role: primary

[email protected]
+39081/5665681

References

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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.

Reference Type DERIVED
PMID: 23375329 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20832596 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19050436 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id