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

Launched by BEIJING NORTHLAND BIOTECH. CO., LTD. · Jun 15, 2025

Keywords

ClinConnect Summary

This is a long-term, observational study following people who were part of Phase III trials for a gene therapy called Donaperminogene Seltoplasmid Injection (NL003) used to treat critical limb ischemia (CLI), a serious blockage of leg arteries that can cause pain, ulcers, and a risk of amputation. The study will watch participants for at least 36 months after their first dose to learn about safety and whether NL003 helps people live longer without major problems like amputation or needing another procedure to restore blood flow. Key things they’ll track include adverse events, tumors, vision problems, major cardiovascular events, and amputation-free survival, plus several combined outcomes that also count procedures to reopen the leg’s blood vessels or promote new blood vessel growth.

Adults aged 20 to 85 who already took part in the Phase III trials and received at least one dose of NL003 or placebo may be invited to participate (about up to 542 people are expected). This is an observational study, so no new treatment is given; researchers will use data from the prior trial and gather new information through online surveys every roughly 3 months for up to 36 months after the first dose. It’s being conducted at several centers in China and is sponsored by Beijing Northland Biotech. Results from this study are not yet available.

Gender

ALL

Eligibility criteria

• 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.