Enrolling by invitation

Donaperminogene Seltoplasmid Injection for Critical Limb Ischemia

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What is being collected

Data Collection

Who is being recruted

Chronic Limb-Threatening Ischemia+24

+ Arterial Occlusive Diseases

+ Arteriosclerosis

From 20 to 85 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2025
See protocol details

Summary

Principal SponsorBeijing Northland Biotech. Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 30, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on individuals who previously participated in Phase III trials for a treatment known as Donaperminogene Seltoplasmid Injection, which is used for critical limb ischemia, a severe condition that affects blood flow to the legs. The aim is to follow these participants over an extended period to understand the long-term effects and benefits of this treatment. The study is important because it could provide valuable information on the longevity and potential risks of the treatment, ultimately improving care for patients suffering from critical limb ischemia. The study involves both remote and in-person follow-ups, depending on what is feasible for participants. It collects data from previous clinical visits and continues gathering new information for at least 36 months after the last participant receives their first dose. Researchers are evaluating several outcomes, including the time until any necessary limb amputation, death from any cause, or the need for further procedures to improve blood flow. They are also monitoring for any adverse events, new tumor developments, major cardiovascular events, and vision changes. This comprehensive follow-up seeks to confirm the safety and effectiveness of the treatment over the long term.

Official TitleMulticenter Cohort Long-term Follow-up Study of Participants From Phase III Clinical Trials of Donaperminogene Seltoplasmid Injection for Critical Limb Ischemia
NCT07023965
Principal SponsorBeijing Northland Biotech. Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

542 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic Limb-Threatening IschemiaArterial Occlusive DiseasesArteriosclerosisArteriosclerosis ObliteransCardiovascular DiseasesChronic DiseaseDiabetes MellitusDiabetic AngiopathiesDiabetic NeuropathiesEndocrine System DiseasesIschemiaLeg UlcerPathologic ProcessesSkin DiseasesSkin UlcerPathological Conditions, Signs and SymptomsThromboangiitis ObliteransVascular DiseasesVasculitisPeripheral Vascular DiseasesFoot UlcerSkin and Connective Tissue DiseasesDiabetic FootDisease AttributesDiabetes ComplicationsAtherosclerosisPeripheral Arterial Disease

Criteria

1 inclusion criteria required to participate
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.
2 exclusion criteria prevent from participating
Participants who refused to provide written informed consent;
Participants who refused to cooperate with the retrospective or prospective data collection.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, ChinaOpen Peking Union Medical College Hospital, Chinese Academy of Medical Sciences in Google Maps
Suspended

Chifeng Municipal Hospital

Chifeng, China
Suspended

zhongshan Hospital Affiliated of Dalian University

Dalian, China
Suspended

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China
Enrolling by invitation5 Study Centers