Announcement on the clinical trial BOOSTB4
In Sweden, the Karolinska Institutet and the Karolinska University Hospital are leading the academic clinical trial BOOSTB4 where we are looking for subjects who have a diagnosis of OI Type III or severe Type IV with a specific collagen mutation. The aim of the clinical trial is to study the safety and efficacy of the investigational drug BOOST cells (fetal mesenchymal stem cells) on fracture occurrence, growth, bone mineral density, biochemical bone turnover and quality of life in children who have OI.
The BOOSTB4 trial includes 2 groups of children, the postnatal group (15 children) and prenatal group (5 children), who will receive 4 doses of BOOST cells. Currently, 9 children from several European countries have received between 1 and 4 doses of the BOOST cells and 13 children have been included in the postnatal group. No significant side effects have been detected during the trial so far.
The postnatal group
The postnatal group is open to children up to 18 months of age who have a diagnosis of OI Type III or severe Type IV with a collagen mutation (glycine substitution in COL1A1 or COL1A2). All 15 participants receive 4 doses of BOOST cells 4 months apart.
The prenatal group
The prenatal group is open since June 2021. In this group 1 dose of BOOST cells will be administered to affected fetuses before birth, followed by 3 doses of BOOST cells four months apart after birth.
The trial welcomes children and pregnant women from within Europe to Karolinska University Hospital in Stockholm, Sweden. The trial can include new participants until February 2022. Dr Eva Åström is the Principal Investigator for the clinical trial.
For more information, such as the inclusion and exclusion criteria, please visit the website www.BOOSTB4.eu.
If you have any additional questions, please contact the researchers via the email address BOOSTB4@clintec.ki.se.
Disclaimer: The OIFE is not involved in the design or management of research studies we announce and as such, is neither endorsing nor supporting these studies. The mission of the OIFE is to keep the OI community informed of all relevant studies. This information is made available as a service to the OI community. We are available to answer questions on this or any other research announcements. Please contact the OIFE at firstname.lastname@example.org if you have any questions