NCT00306085

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

March 22, 2006

Status Verified

March 1, 2006

First QC Date

March 14, 2006

Last Update Submit

March 21, 2006

Conditions

Peripheral Vascular Diseases

Keywords

Peripheral arterial disease,blood marrow cells,therapeutic angiogenesis.

Outcome Measures

Primary Outcomes (1)

  • Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.

Secondary Outcomes (1)

  • Angiographic and laser doppler measurements after six months from treatment.

Interventions

Autologous bone marrow cellsGENETIC

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of third or fourth class of peripheral atherosclerosis

You may not qualify if:

  • Insuline dependent diabetes
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples

Naples, 80134, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23375329DERIVED

  • 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.

    PMID: 20832596DERIVED

  • 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.

    PMID: 19050436DERIVED

MeSH Terms

Conditions

Peripheral Vascular DiseasesPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAtherosclerosisArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Vincenzo Sica

    University of Naples

    STUDY DIRECTOR

Central Study Contacts

Heidi Eisele

CONTACT

+39 081/5665685heidi.eisele@unina2.it

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 22, 2006

Study Start

April 1, 2005

Study Completion

April 1, 2006

Last Updated

March 22, 2006

Record last verified: 2006-03

Locations

IT(1)