274. 骨形成不全症 Osteogenesis Imperfecta Clinical trials / Disease details
臨床試験数 : 91 / 薬物数 : 101 - (DrugBank : 20) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 48
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03706482 (ClinicalTrials.gov) | August 12, 2019 | 5/10/2018 | Boost Brittle Bones Before Birth | 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 | Osteogenesis Imperfecta | Biological: BOOST cells | Karolinska Institutet | Karolinska University Hospital;Great Ormond Street Hospital for Children NHS Foundation Trust;University College, London;Universitätsklinikum Köln;UMC Utrecht;Leiden University Medical Center;Lund University | Active, not recruiting | N/A | 18 Months | All | 18 | Phase 1/Phase 2 | Sweden |
| 2 | NCT04623606 (ClinicalTrials.gov) | May 20, 2019 | 18/9/2020 | Boost to Brittle Bones - Stem Cell Transplantation for Treatment of Brittle Bones | Exploratory, Open Label, Multiple Dose, Phase I/II Trial Evaluating Safety, Efficacy of Intravenous and Intraosseous Infusion of Allogeneic Fetal Mesenchymal Stem In Treatment of Severe Osteogenesis Imperfecta Compared With Historical and Untreated Prospective Controls | Osteogenesis Imperfecta | Biological: BOOST cells | Christian Medical College, Vellore, India | Ministry of Science and Technology, India;Vinnova;Karolinska Institutet | Recruiting | 1 Year | 8 Years | All | 15 | Phase 1/Phase 2 | India |
| 3 | EUCTR2015-003699-60-SE (EUCTR) | 28/09/2018 | 23/07/2018 | Treatment of severe congenital Brittle bone disease after or before and after birth. | 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. | Treatment of Osteogenesis Imperfecta (OI) type III and severe type IV.;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Expanded human first trimester fetal liver-derived mesenchymal stem cells Product Code: BOOST cells | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Sweden |