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Tolerogenic Fibroblasts · MSFibroblast

Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis

Ensayo de FibroBiologics, Inc. en Esclerosis multiple remitente-recurrente.

Más ensayos de: Esclerosis múltiple remitente-recurrente · Esclerosis múltiple.

Fase

Fase 1 temprana

Estado

Completado

Participantes

5

previstos

Centros

1

Fin del objetivo primario

jun 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en sep 2020.

Qué mide

Safety: Adverse even monitoring of subjects for 4 hours after infusion (Monitoring during the Intravenous infusion of allogeneic tolerogenic fibroblasts, and continued for 4 hours after infusion) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroFibroblasts have demonstrated potent immune modulatory and therapeutic activity in the experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis, as well as in other models of autoimmune and inflammatory diseases. This study will assess primary safety and secondary efficacy endpoints of intravenous administration of 100 million tolerogenic fibroblasts to 5 patients with relapsing remitting MS resistant to interferon. While the safety of fibroblasts administered clinically is established, it is unknown whether these cells are effective in the treatment of multiple sclerosis (MS). Our hypothesis is that the tolerogenic fibroblasts will be well-tolerated and meet our primary objective. In addition, The investigators are optimistic that they will see signs of efficacy based on the following: Neurological assessment of the MS functional composite assessment which comprises of EDSS, the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time, short-form 36 (SF-36) quality of life questionnaire and gadolinium-enhanced MRI scans of the brain and cervical spinal cord.

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Ficha completa en ClinicalTrials.gov (NCT05080270), actualizada en oct 2021.