An exploratory open-label multicentre phase I/II trial evaluating the safety and efficacy of postnatal or prenatal and postnatal administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of severe osteogenesis imperfecta in infants and fetuses: the BOOSTB4 trial protocol.
Rachel L SagarEva ÅströmLyn S ChittyBelinda CroweAnna L DavidCatherine DeVileAnnabelle ForsmarkVera FranzenGöran HermerenMelissa HillMats JohanssonCaroline LindemansPeter LindgrenWouter NijhuisDick OepkesMirko RehbergNils-Eric SahlinRalph SakkersO SemlerMikael SundinLilian Walther-JallowE J T Joanne VerweijMagnus WestgrenCecilia GötherströmPublished in: BMJ open (2024)
EudraCT 2015-003699-60, EUCT: 2023-504593-38-00, NCT03706482.
Keyphrases
- study protocol
- open label
- phase iii
- phase ii
- clinical trial
- mesenchymal stem cells
- randomized controlled trial
- preterm infants
- bone marrow
- stem cell transplantation
- pregnant women
- double blind
- umbilical cord
- early onset
- phase ii study
- radiation therapy
- gestational age
- cross sectional
- combination therapy
- hematopoietic stem cell
- cell therapy
- replacement therapy
- bone regeneration