The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase III clinical study to treat their critical limb ischemia (CLI). The main questions it aims to answer are: * First, what medical problems do participants have after taking drug NL003 to treat CLI? * Second, does drug NL003 make CLI participants live longer without serious problems (amputations or target vessel revascularizations) ? Participants who have already received drug NL003 for CLI will complete online surveys about their health conditions. This study will continue until at least 36 months after the participant's first dose.
Age range
20 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of benign and malignant tumors
Timeframe: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of significant vision loss, blindness, or other obvious visual abnormalities
Timeframe: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Incidence of major cardiovascular and cerebrovascular events
Timeframe: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Pregnancy status and its outcomes
Timeframe: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Amputation-free survival of the trial limb
Timeframe: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Amputation-free survival or target vessel revascularization composite endpoint
Timeframe: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose
Amputation-free survival or target vessel revascularization or neovascularization therapies (including stem cell or gene therapy) composite endpoint
Timeframe: Every 3±1 months after enrollment, continuing until at least 36 months after the first dose