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Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
Sponsor: Pell Bio-Med Technology Co., Ltd.
Summary
According to health authorities guidances (FDA 2006, EMA(European Medicines Agency) 2009) for gene therapy clinical trials, observing subjects for delayed adverse events for 15 years is recommended. This purpose of this long-term follow-up study is to evaluate the safety and efficacy in patients who have ever received lentiviral-based gene-edited immune cells which are manufactured by Pell Bio-Med Technology Co. Ltd.
Official title: Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
49
Start Date
2022-12-29
Completion Date
2037-12
Last Updated
2025-05-13
Healthy Volunteers
No
Conditions
Interventions
Pell's lentiviral-based gene-edited immune cell therapy
No study drug or other planned treatment will be administered. Subjects who previously received Pell's lentiviral-based gene-edited immune cell therapy will be evaluated the safety and efficacy.
Locations (5)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan
Chi Mei Medical Center
Tainan, Taiwan
Taipei Medical University - Taipei Medical University Hospital
Taipei, Taiwan