A Long-Term Follow-up Study of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product.
Recruiting · NCT07629115 · Observational (researchers observe without assigning treatment) · Lead sponsor: Innopeutics Corporation
View the official record on ClinicalTrials.gov →What this trial is about
The purpose of this study is to evaluate the long-term safety of IPS101A and to assess the durability of efficacy in subjects who received IPS101A.
Who can take part
Age range
50 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Subjects who were enrolled in the IPS101A-10 clinical trial and received IPS101A.
- Subjects and/or their legally acceptable representatives who voluntarily provided written informed consent to participate in this long-term follow-up study after being fully informed of the study, and who agreed to comply with all study-related requirements.
Exclusion criteria
- Subjects who decline to provide consent for participation in the long-term follow-up study, or for whom follow-up assessments are not feasible due to death or other reasons.
- Subjects who, in the judgment of the investigator, are considered unsuitable for participation in the study due to unwillingness or inability to comply with scheduled study visits or other study-related requirements.
Where it is running
1 location listed.
- Severance Hospital - Seoul, South Korea