Google
Trusted Resources: News & Events
Latest announcements and gatherings
SCDAA News Advisory: Partial Hold on Gene Therapy Trial
On December 20, the FDA placed a partial hold on bluebird bio’s clinical program for lovotibeglogene autotemcel (lovo-cel) gene therapy, temporarily stopping testing on study volunteers under age 18. This partial hold was a response to the investigation of one adolescent with sickle cell disease who has persistent anemia (not dependent on transfusion) a year and a half following treatment. Read more.
Adults can continue enrollment and treatment in bluebird bio studies. Other clinical research studies of gene therapy for sickle cell disease are continuing.
The clinical research process has many built-in safety precautions, which include the partial hold implemented by the FDA. MARAC will continue to monitor the situation closely on behalf of the individuals and families living with sickle cell disease.
+myBinderRelated Content
-
Gamida Cell to Present Data from NiCord® Programs at the 2018 BMT Tandem MeetingsGamida Cell, a leading cellular and immu...
-
Gene-Edited ‘Supercells’ Make Progress In Fight Against Sickle Cell DiseaseDoctors are reporting the first evidence...
-
Prevention of acute sickle cell crisis: review of the NEJM reportA recent article in the New England Jour...
-
Reproductive Health CHOICES for Young Adults with Sickle Cell Disease or Trait: Randomized Controlled Trial Outcomes...Interventions to assist reproductive hea...
-
bluebird bio Presents New Data from HGB-205 Study of LentiGlobinTM Drug Product in Patients with Transfusion-Depende...First patient with severe sickle cell di...
-
NHLBI Stepping Up Efforts to Apprise SCD Patients of Therapies and TrialsWide interest in a CBS 60 Minutes story ...
-
Sickle Cell Patient Receives CRISPR Gene TherapyMany human diseases can be traced back t...
To improve your experience on this site, we use cookies. This includes cookies essential for the basic functioning of our website, cookies for analytics purposes, and cookies enabling us to personalize site content. By clicking on 'Accept' or any content on this site, you agree that cookies can be placed. You may adjust your browser's cookie settings to suit your preferences. More Information
The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.
Powered by
Support for this site is provided by
This platform is made possible through a partnership with the Sickle Cell Disease Association of America, Inc. (SCDAA) and its member organizations. SCDAA's mission is to advocate for people affected by sickle cell conditions and empower community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.