Status:
ACTIVE_NOT_RECRUITING
Long-term Follow-up of Subjects Treated With OTL-300 for Transfusion Dependent Beta-thalassemia Study (TIGET-BTHAL)
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
Telethon Institute for Gene Therapy (OSR-TIGET)
Conditions:
Beta Thalassaemia
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
OTL-300 is a gene therapy drug product consisting of autologous hematopoietic stem/progenitor cluster of differentiation (CD) 34+ cells genetically modified with a lentiviral vector (GLOBE) encoding t...
Eligibility Criteria
Inclusion
- Subjects who have completed study TIGET-BTHAL i.e. who have received treatment and been followed for two years post treatment with OTL-300.
- For adults; capable of giving signed informed consent. For children; informed assent and/or consent in writing signed by the subject and/or parent(s) / legal representative (according to local regulations and age of the subject).
Exclusion
- None
Key Trial Info
Start Date :
October 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03275051
Start Date
October 4 2017
End Date
June 1 2026
Last Update
November 23 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale San Raffaele - Telethon Institute for Gene Therapy (OSR-TIGET)
Milan, Italy, 20132