Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
Key facts
- Where
- Beijing, Chifeng, Dalian, Hangzhou, and Xi’an, ChinaSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 85 years old?
Source: NCT07023965, who can take part
Where in China
- Peking Union Medical College Hospital, Chinese Academy of Medical SciencesBeijing, ChinaNo longer taking part
- Chifeng Municipal HospitalChifeng, ChinaNo longer taking part
- zhongshan Hospital Affiliated of Dalian UniversityDalian, ChinaNo longer taking part
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing Northland Biotech. Co., Ltd.
- Trial code
- NCT07023965
- Record updated
- 11 July 2025
- Original description
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:Read full original descriptionShow less
Multicenter Cohort Long-term Follow-up Study of Participants From Phase III Clinical Trials of Donaperminogene Seltoplasmid Injection for Critical Limb Ischemia
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.
Inclusion: Participants who have previously enrolled in Phase III clinical trials of recombinant human hepatocyte growth factor plasmid injection (Donaperminogene Seltoplasmid Injection) for the treatment of critical limb ischemia (including ulcers and rest pain) and have received at least one dose of the treatment.
Exclusion: Participants who refused to provide written informed consent; Participants who refused to cooperate with the retrospective or prospective data collection.