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RESEARCH PRODUCT
Intraspinal stem cell transplantation for amyotrophic lateral sclerosis: Ready for efficacy clinical trials?
Miguel BlanquerEnrica BersanoCesare GiorgiMaurizio GelatiDaniela Celeste ProficoDaniela Celeste ProficoStephen B. DunnettRoberto CantelloNazem AtassiPierdavide GuenziAntonia FollenziMariagrazia GrilliGabriele PanzarasaAlessandro VercelliLetizia MazziniFabiola De MarchiVincenzo SilaniM. PoloniPier Giorgio CarVincenzo La BellaCaterina BendottiAngelo L. VescoviEttore BeghiRossella SpataroRoberto FantozziNicholas M. BoulisGianni SorarùClaudia CaponnettoAdriano ChiòGianluigi MancardiSimona BrajkovicAlessandro SteccoEva L. Feldmansubject
0301 basic medicineCancer ResearchCell- and Tissue-Based Therapy0302 clinical medicinePublic discussionNeural Stem CellsImmunology and AllergyNeural Stem CellALS; clinical trials; stem cells; transplantation; Immunology and Allergy; Immunology; Oncology; Genetics (clinical); Cell Biology; Cancer Research; TransplantationAmyotrophic lateral sclerosisGenetics (clinical)clinical trialMiddle AgedOncologyStem cellSafetyHumanAdultmedicine.medical_specialtyConsensusAdolescentImmunologyConsensu03 medical and health sciencesTherapeutic approachYoung AdultClinical Trials Phase II as Topicstem cellsmedicineHumansIntensive care medicineAgedclinical trialsTransplantationbusiness.industryAmyotrophic Lateral SclerosisBIO/13 - BIOLOGIA APPLICATACell Biologymedicine.diseasestem cellClinical trialTransplantation030104 developmental biologyClinical Trials Phase III as TopicImmunologyALSbusiness030217 neurology & neurosurgeryAmyotrophic Lateral SclerosiStem Cell Transplantationdescription
Intraspinal stem cell (SC) transplantation represents a new therapeutic approach for amyotrophic lateral sclerosis (ALS) clinical trials. There are considerable difficulties in designing future efficacy trials, some related to the field of ALS and some that are specific to SCs or the mode of delivery. In October 2015, the most controversial points on SC transplantation were addressed during an international workshop intended to bring together international SC and ALS researchers in a public discussion on a topic for which expertise is limited. During the meeting, a discussion was started on the basic structure of the ideal clinical trial testing the efficacy and safety of SC transplantation. The current document includes a number of consensus points reflecting the design of phase II/III clinical trials.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2016-01-01 | Cytotherapy |