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 study is a multicenter, open-label, long-term follow-up cohort study. A remote follow-up system is recommended as a tool for the study, however, in-person visits or phone calls at the research center will be conducted if remote follow-up is not feasible. The study will retrospectively collect data from the last visit in the parent Phase III study and prospectively gather data following informed consent. It will continue until at least 36 months after the first dose administered to the last enrolled participant.

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.