17th March, 2020 - Clinical trial has started.
The BOOSTB4 project consortium announces initiation of the clinical trial phase of the project with the enrolment of the first patient to the trial on March 17, 2020. The patient received the first of four fetal Mesenchymal Stem Cell (fMSC) infusions at the Karolinska University Hospital in Stockholm, Sweden and was discharged as planned at the conclusion of a monitoring period of 48 hours. Three more infusions will follow with a 3-5 month separation between infusions.
The principal objective of the European Commission’s Horizon 2020 funded BOOSTB4 project (Grant Agreement number 681045) is to conduct a Phase I/II clinical trial of the safety and efficacy of pre- and/or postnatal fMSC transplantation in the severest forms of OI (type III, severe type IV). The trial’s primary outcome is safety; secondary outcomes relate to efficacy (fracture frequency, growth, bone mineral density and quality of life). Although the trial will involve recruitment of pre-natal as well as post-natal patients, the first 5 patients to be recruited will be to the post-natal arm of the trial to allow a safety evaluation to be undertaken before the pre-natal arm of the trial is opened.
Due to the current coronavirus epidemic, we will be unable to recruit additional subjects to the trial in the near-term.
18th and 19th November 2018 – BOOSTB4 consortium meeting in Leiden, The Netherlands.
15th October 2018 – UK trial application submitted to the UK Competent Authority, MHRA, for evaluation.
15th October 2018 – Paul-Ehrlich-Institut, the Competent Authority in Germany, confirms receipt of a complete submission of BOOSTB4 trial documents for evaluation.
4th October 2018 – Karolinska Institutet given regulatory approval to begin the BOOSTB4 study by the Swedish Medical Products Agency.
3rd October 2018 – Ethical review board in Stockholm granted Karolinska Institutet permission to conduct the BOOSTB4 trial.
1st October 2018 – BOOSTB4 meeting with MHRA in London to discuss submission to the Competent Authority.
14th August 2018 – Raymond Dalgleish (University of Leicester PI) has secured a grant from Care4BrittleBones, the Dutch OI charity, to bring the OI variant database up to date and transfer the content of the database into the new software.
24th – 25th April 2018 – BOOSTB4 consortium meeting in Lund, Sweden.
20th – 21st September 2017 – BOOSTB4 consortium meeting in Utrecht, The Netherlands.
6th – 7th March 2017 – BOOSTB4 consortium meeting in Cologne, Germany.
11th – 12th October 2016 – BOOSTB4 consortium meeting in London, United Kingdom.
March 2016 – Cecilia Götherström (Project coordinator at Karolinska Institutet) speaks about the BOOSTB4 project on UK television, BBC Two: Incredible Medicine: Dr Weston's Casebook, episode 6.
25th – 26th January 2016 – BOOSTB4 consortium kick-off meeting in Stockholm, Sweden.