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

This study has been completed.
Information provided by (Responsible Party):
Vittorio Arici, IRCCS Policlinico S. Matteo Identifier:
First received: February 14, 2012
Last updated: June 13, 2012
Last verified: June 2012

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

Condition Intervention Phase
Critical Limb Ischemia
Other: Endothelial progenitor cells intramuscular implant
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Immunomagnetic Selected cd133+ Cells in the Treatment of No-option Critical Limb Ischemia: Clinical and Ceus Assessed Results.

Resource links provided by NLM:

Further study details as provided by Vittorio Arici, IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • Contrast enhanced ultrasound (CEUS) [ Time Frame: 3-6-12 months ]
    Muscular and arterial ultrasound before and after endovenous injection of contrast medium (SonoVue BR1; Bracco, Milan, Italy)

Secondary Outcome Measures:
  • Pain relief [ Time Frame: 3-6-12 months ]
    Monitoring the use of pain killing drugs

  • ulcer healing [ Time Frame: 3-6-12 months ]
    monitoring the healing of trophic lesions

Enrollment: 8
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm: autologous EPCs 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.
Other Name: Cell therapy in critical limb ischemia.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. age > 18 years
  2. written informed consent
  3. critical limb ischemia (TASC 2 criteria)
  4. No surgical nor endovascular options

Exclusion criteria:

  1. clinical instability
  2. extensive gangrene
  3. every serious systemic disease
  4. life expectancy < 24 months
  5. previous similar studies
  6. previous experimental drug studies within 3 months
  7. allergy
  8. child bearing age
  9. conflict of interest in the study
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Please refer to this study by its identifier: NCT01595776

Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Study Director: Attilio Odero, Professor Department of Vascular Surgery - Fondazione IRCCS Policlinico S. Matteo, Pavia - Italy
  More Information

Arici V, Bozzani A, Ragni F, Perotti C, Del Fante C, Calliada F, Pagani M, Odero A, Autologous endothelial progenitor cells derived from peripheral blood for the treatment of critical limb ischemia in no-option patients: pilot study, Ital J Vas Endovasc Surg 2010; 17(3) Suppl 1: 11-4

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vittorio Arici, Principal Investigator, IRCCS Policlinico S. Matteo Identifier: NCT01595776     History of Changes
Other Study ID Numbers: CHVAS-01-08
Study First Received: February 14, 2012
Last Updated: June 13, 2012

Keywords provided by Vittorio Arici, IRCCS Policlinico S. Matteo:
CLI, PAD, Buerger disease

Additional relevant MeSH terms:
Pathologic Processes processed this record on May 25, 2017