Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury (NCT02917291) | Clinical Trial Compass
UnknownPhase 1/2
Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury
Spain48 participantsStarted 2016-12
Plain-language summary
The main objective of the study is the evaluation of the safety and tolerability of FAB117-HC (a medicinal product containing human allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, HC016 cells) administered at a single-time point to patients with acute thoracic traumatic spinal cord injury (SCI). The study will also include initial exploration of potential clinical efficacy. Dose levels of 20 million and 40 million cells will be administered.
Who can participate
Age range16 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female subjects ≥ 16 to ≤ 70 years.
✓. ASIA impairment grade A.
✓. Either a level of injury between D1-D12 both inclusive (cohorts 1 and 2).
✓. Single traumatic spinal cord injury as defined by MRI.
✓. Injury occurred between 72 and 120h before undergoing DSS and treatment.
✓. Clinically and haemodynamically stable, under medical criteria, enough to undergo DSS.
✓. Able to give informed consent either in writing or orally in the presence of a witness.
✓. Male or female subjects ≥ 16 to ≤ 70 years.
Exclusion criteria
✕. Participated in a previous clinical study and received an investigational product within 28 days of SCI (within 5 years of SCI if the investigational product is a cell-based medicine).
✕. Radiological or MRI or DSS evidence of complete or partial spinal cord transection.
✕. Inability to unequivocally identify the injection sites.
✕. Multiple injuries to the neurological spinal cord at different levels.
✕. Patients with any of these additional conditions:
What they're measuring
1
Number of adverse events as a measure of safety and tolerability of a single dose of FAB117-HC when administered by intramedullary injection into the injured spinal cord