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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vittorio Arici, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT01595776
First received: February 14, 2012
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • Contrast enhanced ultrasound (CEUS) [ Time Frame: 3-6-12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Monitoring the use of pain killing drugs

  • ulcer healing [ Time Frame: 3-6-12 months ] [ Designated as safety issue: No ]
    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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Vittorio Arici, Principal Investigator, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT01595776     History of Changes
Other Study ID Numbers: CHVAS-01-08
Study First Received: February 14, 2012
Last Updated: June 13, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014