Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital de Neurorehabilitació Institut Guttmann | UNKNOWN |
| Recerca ClÃnica S.L. | INDUSTRY |
| Syntax for Science, S.L | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XCEL-UMC-BETA/placebo | Experimental | Ex vivo cultured human mesenchymal stem cells from Wharton jelly, in a blinded syringe (initial treatment) / Placebo (month 6) |
|
| Placebo/XCEL-UMC-BETA | Placebo Comparator | Placebo in a blinded syringe (initial treatment) / XCEL-UMC-BETA (month 6) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XCEL-UMC-BETA | Drug | Intrathecal allogeneic cell therapy in a blinded syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Adverse events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Extent and severity of a patient's spinal cord injury | ASIA Impairment Scale | 6 months |
| Motor electrophysiology assessment | Evoked potentials |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joan Vidal, MD, PhD | Hospital de Neurorehabilitació Institut Guttmann | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Neurorehabilitació Institut Guttmann | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32981857 | Derived | Albu S, Kumru H, Coll R, Vives J, Valles M, Benito-Penalva J, Rodriguez L, Codinach M, Hernandez J, Navarro X, Vidal J. Clinical effects of intrathecal administration of expanded Wharton jelly mesenchymal stromal cells in patients with chronic complete spinal cord injury: a randomized controlled study. Cytotherapy. 2021 Feb;23(2):146-156. doi: 10.1016/j.jcyt.2020.08.008. Epub 2020 Sep 25. |
| Label | URL |
|---|---|
| Hospital de Neurorehabilitació Institut Guttmann | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo in a blinded syringe |
|
| 6 month |
| Somatosensory electrophysiology assessment | Evoked potentials | 6 month |
| Electrical nerve stimulation on pain perception | Pain threshold perception | 6 month |
| Mictional dysfunction | Urodynamic testing | 6 month |
| Anal sphincter integrity | Anorectal manometry test | 6 month |
| Neuropathic pain | Numerical scale (0 to 10) | 6 months |
| Spasticity | Modified Ashworth scale | 6 months |
| Functionality | SCIM III scale | 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 | 6 months |
| Urinary disorder | Qualiveen questionnaire | 6 months |
| Size injury | Magnetic Resonance Imaging | 12 months |
| Presence of allogeneic cells | Chimerism in cerebrospinal fluid | 1 month |
| Immunology | Antibodies anti-HLA in peripherical blood and in cerebrospinal fluid | 1 months |
| Marató TV3 | View source |
| D014947 | Wounds and Injuries |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |