Patients with acute traumatic spinal cord injury MedDRA version: 18.1 Level: LLT Classification code 10043064 Term: T7-T12 level spinal cord injury, unspecified System Organ Class: 100000004863 MedDRA version: 18.1 Level: LLT Classification code 10043046 Term: T1-T6 level spinal cord injury, unspecified System Organ Class: 100000004863
Conditions
Interventions
Product Name: ALLOGENEIC ADIPOSE DERIVED ADULT MESENCHYMAL STEM CELLS EXPANDED AND PULSED WITH H2O2 (HC016)
Product Code: FAB117-HC
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: F
Sponsors
Ferrer Internacional S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PHASE 1: 1. Male or female subjects ? 18 to ? 65 years. 2. ASIA A. 3. Spinal Injury with neurological level between D5?D10 (cohorts 1 and 2) 4. Single traumatic spinal cord injury as defined by MRI. 5. Injury occurred between 72 and 120 h before undergoing DSS and treatment. 6. Clinically and haemodynamically stable enough to undergo DSS. 7. Able to give informed consent either in writing or verbally in the presence of a witness. PHASE 2: 1. Male or female subjects ? 18 to ? 65 years. 2. ASIA A or B. 3. Spinal Injury with neurological level between (D1?D12) (D12 without ZPPM). 4. Single traumatic spinal cord injury as defined by MRI. 5. Injury occurring between 24 and 72h before undergoing DSS and treatment. 6. Clinically and hemodynamically stable enough to undergo DSS. 7. Able to give informed consent either in writing or verbally in the presence of a witness. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Research 1. Participation in any clinical investigation within 28 days prior to spinal cord injury or if a cell therapy product has been administrated in the previous five years of SCI Local 2. MRI or DSS evidence of complete spinal cord transection or equivalent severe lesion or abnormality. 3. Inability to unequivocally identify the injection sites. 4. Multiple injuries to the neurological spinal cord at different levels. 5. Patients with any of these additional conditions: a. Penetrating spinal cord injuries. b. Associated trauma or injury to the brachial and / or lumbosacral plexus. 6. Active infection in the surgical area. Surgical risk and clinical condition 7. Haemodynamic instability contraindicating DSS procedure in the time frame defined for inclusion in the trial. 8. Multiple organ failure. Neurological 9. Significant head injury (Score on the Glasgow scale less than or equal to 13 and / or abnormal MRI/CT) or other injury that, in the investigator's opinion, is sufficient to interfere with the assessment of spinal cord function or compromise the validity of patient data. 10. Patients undergoing mechanical ventilation that does not allow a prior clinical examination. 11. Inability to communicate with the neurological examiner, so that the validity of patient data could be unreliable. 12. Patients who are unconscious, including those unconscious to require sedative-analgesic medications. Basal condition and personal clinical history 13. Preexisting or current significant diseases such as hepatitis C, HIV, epilepsy, neoplastic disease or other diseases that could cause neurological deficits, including syphilis, myelopathy, and polyneuropathy. 14. Background or acute episode of Guillain?Barre syndrome. 15. History of meningitis or meningoencephalitis. 16. Current history of autoimmune disease. 17. Patients with uncontrolled blood diathesis or under anticoagulant or antiplatelet pharmacological therapy. 18. Presence of any psychiatric illness, as defined by the DSM-IV-TR, or medically unstable illness which can reasonably be expected to pose an increased risk to on participating in the study, or which causes a significant deterioration of the clinical course of the patient. Secondary depression is expressly excluded. 19. Drug abuse as defined by DSM-IV-TR during the 6 months prior to SCI. 20. Pregnant women. 21. Women who are breastfeeding if unwilling to stop at the time of recruitment. 22. History of life-threatening allergy or immune reaction. 23. Patients with known hypersensitivity to any of the excipients of FAB117-HC. 24. Patients with known or suspected hypersensitivity.to bovine serum, enzymes (trypsin, collagenase type I / II), penicillin, streptomycin or DMSO
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and tolerability of intra-medullary administration of FAB117-HC, an allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2 (HC016) drug, in patients with acute thoracic spinal cord injury. The clinical assessments will be done: screening (2-24 h before drug administration), 24h, 72h, 7d, 14d, 28d and 90d after the drug administration);Secondary Objective: Investigate early signs of potential clinical efficacy of FAB117-HC by: 1) Evaluation of motor, sensory and disability (ASIA) scores using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) at selection phase and 24h, 72h, 7d, 14d, 28d and 90d after the intra-medullary treatment with FAB117-HC. After completion of the trial, patients will be assessed at 180 and 360 follow-up period. 2) Functional Assessment by Spinal Cord Independence Measure (SCIM III) on selection phase and 28day and 90day after FAB117-HC intra-medullary treatment 3) Evaluate electrophysiological changes on 28day and 90day after FAB117-HC intra-medullary administration by: a. Somatosensory-Evoked Potentials (SSEP) b. Motor-Evoked Potentials (MEP): c. Nerve conduction velocities;Primary end point(s): The incidence of Serious Adverse Events, Adverse Events, and Clinical Assessments.;Timepoint(s) of evaluation of this end point: During all the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Variation on the motor and sensory scores from selection phase using the following scales: 1) Change on one or more levels in the disability scale (AIS) of the American Spinal Injury Association (ASIA); or 2) Increase of 5 points or more on the LENS punctuation of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) -Changes on the functional assessment by Spinal Cord Independence Measure (SCIM III) on selection phase and 28day and 90day after FAB117-HC treatment -Changes on the electrophysiological assessment at 28day and 90day after FAB117-HC treatment by Somatosensory-Evoked Potentials and Motor-Evoked Potentials (MEP) -Changes on nerve conduction velocity test at 28day and 90day after FAB117-HC treatment;Timepoint(s) of evaluation of this end point: -Variation on the motor and sensory scores from selection -Spinal Cord Independence Measure (SCIM III) on selection phase and 28day and 90day after FAB117-HC treatment -Changes on the electrophysiological assessment at 28day and 90day after FAB117-HC treatment . -Changes on nerve conduction velocity test at 28day and 90day after FAB117-HC treatment | — |
Countries
Spain
Contacts
Public ContactFerrer Advanced Biotherapeutics
Ferrer Internacional S.A.
Outcome results
None listed