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

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ClinicalTrials.gov Identifier: NCT01595776
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
Vittorio Arici, IRCCS Policlinico S. Matteo

Brief 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


Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Other: Endothelial progenitor cells intramuscular implant Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: Single (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.
Study Start Date : January 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. Pain relief [ Time Frame: 3-6-12 months ]
    Monitoring the use of pain killing drugs

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



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595776


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

Publications:
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vittorio Arici, Principal Investigator, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT01595776     History of Changes
Other Study ID Numbers: CHVAS-01-08
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes