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Autologous Endothelial Progenitor Cells (EPCs) From Peripheral Blood in the Treatment of Critical Limb Ischemia

NCT01595776 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-06-14

No results posted yet for this study

Summary

Aim: to value the safety and efficacy of local intramuscular administration of immunoselected autologous endothelial progenitor cells in the treatment of critical limb ischemia in patients without revascularization options.

Primary goal: to value the feasibility of mobilization, harvesting, immunoselection and auto transplantation of endothelial progenitor cells.

Secondary goal: to value the efficacy of local administration of autologous endothelial progenitor cells in the treatment of critical limb ischemia

Conditions

  • Critical Limb Ischemia

Interventions

OTHER

Endothelial progenitor cells intramuscular implant

After marrow stimulation the CD133+ cell count was monitored daily. Each leukapheresis collection was diluted with 10% acide citrate dextrose (ACD-A)CD133 immunomagnetic cell selections were performed . After loco-regional anesthesia and below the knee cutaneous disinfection, 45-48 ml of autologous CD133+ saline solution suspension is administered intramuscularly with 1 ml deep injection through 18G needle. The injections were so allocated: 10 ml in the anterior compartment of leg, 10 ml in the superficial posterior compartment, 10 ml in the deep posterior compartment, 10 ml in the lateral compartment and the remaining part in the foot.

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Attilio Odero, Professor · Department of Vascular Surgery - Fondazione IRCCS Policlinico S. Matteo, Pavia - Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01595776 on ClinicalTrials.gov