2020-01-08
Please spread this information to those with patients relevant to this trial.
The Swedish lead BOOSTB4 project is pleased to announce they are accepting elegible participants from Europe for inclusion in their cell therapy clinical trial for treatment of severe Osteogenesis Imperfecta (OI). The site open for patient recruitment is in Stockholm, Sweden.
The new academic clinical trial, Boost Brittle Bones Before Birth (BOOSTB4), is investigating the safety and effectiveness of either postnatal or pre- and postnatal intravenous administration of fetal mesenchymal stem cells (MSC) as therapy for severe types of OI. This study is based on evidence from 6 children previously treated in the US and 4 in Europe where infusions of mesenchymal stem cells were given to patients and improved growth, reduced fractures and reduced pain was seen compared to the expected. The Swedish researchers have also shown in animals that giving the cells earlier in life has an even greater preventative result against the disease severity, thus their trial plans to administer the cells pre-birth (prenatally).
The current trial is an exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal intravenous administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of severe Osteogenesis Imperfecta compared with a combination of historical and untreated prospective controls. The trial will start with the postnatal transplantation group only. Children must be younger than one year of age at the time of their inclusion i.e. when receiving the first of four transplantations. Prenatal administration is planned to commence in late 2020.
More information is available on the trials web site http://www.boostb4.eu/