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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Autologous Immunomagnetic Selected cd133+ Cells in the Treatment of No-option Critical Limb Ischemia: Clinical and Ceus Assessed Results.

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


Detailed Summary:

Type of the study. Prospective single centre not randomized. Aim of the study. To assess the safety, feasibility and efficacy of local intramuscular administration of autologous selected CD 133+ cells in patients suffering from CLI.

All the patients enrolled were suffering from CLI according to the TASC 2 definitions and had no revascularization option, on the basis of contrast CT or angiography imaging. A detailed informed consent, approved by our EC, had been required. An age lower than 18 years and upper than 70 years because of a poor marrow responsiveness to drug simulation in elderly people Clinical unsteadiness of the CLI, such as gangrene requiring major amputation and a poor life expectancy were introduced as exclusion criteria for supposed latency of the EPCs action. Severe systemic illness was judged to increase the risk of the marrow stimulation. Patients with allergic diathesis, child-bearing age, previous EPCs muscular implant, previous medical experimental protocol and any conflict of interest with the study were excluded.

Patients: we enroll patients with a history of Rutherford stage 4 (rest pain) or 5 (small ischemic lesions) PAD. All the patients have previous (contrast CT, MR or angiography) vascular imaging excluding revascularization options, both endovascular and open and encountered the enrolment and exclusion criteria. Every patient undergo routine physical and instrumental examination including electrocardiogram, chest X-ray and blood sample analysis. Younger patients met the Buerger disease criteria, whereas others had pure atherosclerotic lesions.

CEUS Imaging Protocol. Two operators (F.C. and A.G., with 20 and 3 years experience, respectively) who are blinded to treatment perform contrast-enhanced US for all patients. Two US scanner (Philips iU2
Sponsor: IRCCS Policlinico S. Matteo

Current Primary Outcome: 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)


Original Primary Outcome: Ankle/Brachial Index [ Time Frame: 1 year ]

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

Information By: IRCCS Policlinico S. Matteo

Dates:
Date Received: February 14, 2012
Date Started: January 2009
Date Completion:
Last Updated: June 13, 2012
Last Verified: June 2012