EUCTR2015-005717-80-ES
Active, not recruiting
Phase 1
Clinical trial of phase 1/2 to evaluate the feasibility, safety, tolerability and preliminary efficacy of the administration of FAB117-HC, a drug whose active ingredient is HC016, allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute traumatic spinal cord injury.
ConditionsPatients with acute traumatic spinal cord injuryMedDRA version: 18.1Level: LLTClassification code 10043064Term: T7-T12 level spinal cord injury, unspecifiedSystem Organ Class: 100000004863MedDRA version: 18.1Level: LLTClassification code 10043046Term: T1-T6 level spinal cord injury, unspecifiedSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with acute traumatic spinal cord injury
- Sponsor
- Ferrer Internacional S.A
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female subjects ? 18 to ? 65 years.
- •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.
- •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.
Exclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
Not specified
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