This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age affected with chronic traumatic spinal cord will enter the study with the objective to assess the safety and to obtain efficacy data in intrathecal administration of expanded Wharton's jelly mesenchymal stem cells.
This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo controlled, clinical trial in which 10 patients from 18 to 65 years of age affected with chronic traumatic spinal cord will enter the study with the objective to assess the safety and to obtain efficacy data in intrathecal administration (L3 level) of expanded Wharton's jelly mesenchymal stem cells. Following the administration patients will remain for 24 h at the hospital and thereafter will be discharged. For the first period, the follow-up is planned at day 7 and at 1, 3 and 6 months. At month 6, the patients will be treated in a crossover way (second period) and will follow the same schedule for the follow-up. First clinical trial evaluation will be performed at 12 month follow-up. From 12 to 18 month after the first infusion, patients will be randomized again to active treatment or placebo (double-blind) in order to assess the safety and efficacy of a second dose at 12 month follow-up. Thereafter, patients will be followed up at 24 and 36 months as part of a long-term follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Intrathecal allogeneic cell therapy in a blinded syringe
Placebo in a blinded syringe
Hospital de Neurorehabilitació Institut Guttmann
Badalona, Barcelona, Spain
Incidence of treatment-emergent adverse events
Adverse events
Time frame: 12 months
Extent and severity of a patient's spinal cord injury
ASIA Impairment Scale
Time frame: 6 months
Motor electrophysiology assessment
Evoked potentials
Time frame: 6 month
Somatosensory electrophysiology assessment
Evoked potentials
Time frame: 6 month
Electrical nerve stimulation on pain perception
Pain threshold perception
Time frame: 6 month
Mictional dysfunction
Urodynamic testing
Time frame: 6 month
Anal sphincter integrity
Anorectal manometry test
Time frame: 6 month
Neuropathic pain
Numerical scale (0 to 10)
Time frame: 6 months
Spasticity
Modified Ashworth scale
Time frame: 6 months
Functionality
SCIM III scale
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months
Quality of life (individual overall perception of quality of life, individual overall perception of their health, Physical health, Psychological, Social relationships, Environment)
WHOQOL BREF questionnaire
Time frame: 6 months
Urinary disorder
Qualiveen questionnaire
Time frame: 6 months
Size injury
Magnetic Resonance Imaging
Time frame: 12 months
Presence of allogeneic cells
Chimerism in cerebrospinal fluid
Time frame: 1 month
Immunology
Antibodies anti-HLA in peripherical blood and in cerebrospinal fluid
Time frame: 1 months