Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)

Sponsored by Beijing Northland Biotech. Co., Ltd.

About this trial

Last updated a year ago

Study ID

NL003-CLI-III-L

Status

Enrolling by invitation

Type

Observational

Placebo

Yes

Accepting

20 to 85 Years

All Sexes

Trial Timing

Started a year ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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 Criteria

* Participants who refused to provide written informed consent;

* Participants who refused to cooperate with the retrospective or prospective data collection.