64
Participants
Start Date
January 22, 2016
Primary Completion Date
August 31, 2038
Study Completion Date
August 31, 2038
No interventional drug product utilized in this follow-up study
"Participants received a single IV infusion of Lenti-D Drug Product (also known as elivaldogene autotemcel or eli-cel) in either parent Study ALD-102 or ALD-104.~The objectives of this long-term follow-up study are to assess long-term safety and efficacy following completion of participation in parent studies. Vector copy number (VCN) measurement, safety evaluations, disease-specific assessments, and assessments to monitor for long-term complications of autologous transplant are conducted in this study."
Prinses Maxima Center, Utrecht
University of Minnesota, Minneapolis
Mattel Children's Hospital-UCLA, Los Angeles
Hôpital Bicêtre, Le Kremlin-Bicêtre
Lucile Packard Children's Hospital - Stanford, Palo Alto
Boston Children's Hospital/Massachusetts General Hospital, Boston
Instituto Neurogenia, Caba
Women's and Children's Hospital, North Adelaide
Great Ormond Street Hospital, London
Hospital das Clínicas da Universidade de São Paulo, São Paulo
Universitätsklinikum Leipzig AöR, Leipzig
Ospedale Pediatrico Bambino Gesù, Rome
Royal Free London Hospital, London
Lead Sponsor
Genetix Biotherapeutics Inc.
INDUSTRY