NCT02917291 - Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

July 31, 2022

Study Completion Date

July 31, 2023

Conditions

Acute Traumatic Spinal Cord Injury

Interventions

DRUG

FAB117-HC

(Ph 1) Intramedullary administration. Open label dose escalation, 3 patients in cohort 1 (20 million cells) and 5 patients in cohort 2 (40 million cells)

OTHER

Control group

(Ph 2) No treatment will be administered

DRUG

FAB117-HC

(Ph 2) Intramedullary administration of the maximum tolerated dose (20 or 40 million cells)

Trial Locations (9)

15006

RECRUITING

Complexo Hospitalario Universitario A Coruña, A Coruña

18014

RECRUITING

Hospital Universitario Virgen de las Nieves, Granada

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

41013

RECRUITING

Hospital Universitario Virgen del Rocío, Seville

45071

RECRUITING

Complejo Hospitalario de Toledo (HNP y VS), Toledo

46009

RECRUITING

Hospital Universitari La Fe, Valencia

50009

RECRUITING

Hospital Clínico Universitario Lozano Blesa, Zaragoza

RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona