CompletedPhase 1/2

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

Italy8 participantsStarted 2009-01

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. clinical instability
✕. extensive gangrene
✕. every serious systemic disease
✕. life expectancy \< 24 months
✕. previous similar studies
✕. previous experimental drug studies within 3 months
✕. allergy
✕. child bearing age

What they're measuring

Contrast enhanced ultrasound (CEUS)

Timeframe: 3-6-12 months

Trial details

NCT IDNCT01595776

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-12

View on ClinicalTrials.gov More Critical Limb Ischemia trials