Expanded access to PLX-PAD for critical limb ischemia
Part of Heart & circulation clinical trials.
This trial provides access to an experimental cell therapy called PLX-PAD for people with critical limb ischemia (CLI), a severe form of peripheral artery disease that causes leg pain and wounds that don't heal. The treatment aims to improve blood flow and help heal leg ulcers, potentially avoiding amputation.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are between 45 and 99 years old.
- You have critical limb ischemia (CLI) with minor tissue loss (ulcers or necrosis) up to the ankle level.
- Your leg has poor blood flow, as shown by low ankle or toe pressure or low oxygen levels in the skin.
- Your doctor has determined that you are not a good candidate for standard revascularization (procedures to restore blood flow) due to anatomical, technical, or medical reasons.
- You are not eligible for the ongoing phase III study of PLX-PAD for CLI for specific reasons, such as having osteomyelitis (bone infection), severe kidney disease, or other conditions listed.
- You do not have any of the exclusion criteria, such as non-atherosclerotic PAD, major tissue loss in the leg, active infections, recent surgeries, or certain medical conditions.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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