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Clinical Trial 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.


Clinical Trial Description

After completion or early withdraw from the other treatment protocol, patients should be enrolled into this long-term follow-up study. If patients do not enter this study right after leaving the treatment protocol, they may have the option to enter this long-term follow-up study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05377307
Study type Observational
Source Pell Bio-Med Technology Co., Ltd.
Contact Cherry Lo, MSC
Phone 886-2-8791-1789
Email cherry.lo@pellbmt.com
Status Recruiting
Phase
Start date December 29, 2022
Completion date December 2037

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