A Long-Term Follow-up Study of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product.
2026年6月29日 更新者：Innopeutics Corporation
A Long-Term Follow-up Study to Evaluate the Safety and Efficacy of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product in the IPS101A-10 Phase I Clinical Trial
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.
研究概览
研究类型
观察性的
注册 (估计的)
6
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：ChoLong Park
- 电话号码：+82-2-3499-4266
- 邮箱：clpark@innopeutics.com
研究联系人备份
- 姓名：Tae-gyun Kim
- 邮箱：contact@innopeutics.com
学习地点
-
-
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Seoul、韩国
- 招聘中
- Severance Hospital
-
接触：
- Professor, MD, PhD
- 邮箱：phlee@yuhs.ac
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Subject with advanced Parkinson's disease who received IPS101A gene therapy in the Phase 1 clinical trial (IPS101A-10)
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
The group that received IPS101A
The group of subjects who received IPS101A in the IPS101A-10 clinical trial
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety Evaluation: Incidence of serious adverse events of special interest
大体时间：Baseline to 5 years
|
Assess severity and frequency serious adverse events of special interest
|
Baseline to 5 years
|
|
Safety Evaluation: Incidence of serious adverse events (SAEs) and adverse events (AEs)
大体时间：Baseline to 5 years
|
Assess severity and frequency of reported adverse events
|
Baseline to 5 years
|
|
Safety Evaluation: Number of participants with clinically-relevant changes in physical exams
大体时间：Baseline to 5 years
|
The results of the physical examination after administration of the clinical trial drug are compared with those before administration to determine whether clinically significant symptoms occur
|
Baseline to 5 years
|
|
Safety Evaluation: Number of participants with clinically-relevant changes in laboratory test
大体时间：Baseline to 5 years
|
The clinical significance of laboratory test results after administration of a clinical trial drug is confirmed by comparing them with those before administration.
|
Baseline to 5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores (defined on/off)
大体时间：Baseline to 5 years
|
Each symptom is rated on a scale of 0 to 4, with higher scores indicating more severe Parkinson's disease.
|
Baseline to 5 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月29日
初级完成 (估计的)
2031年7月30日
研究完成 (估计的)
2031年10月30日
研究注册日期
首次提交
2026年5月12日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月5日
研究记录更新
最后更新发布 (实际的)
2026年7月1日
上次提交的符合 QC 标准的更新
2026年6月29日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.