Safety Stem Cells in Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Mono-center, open label study to investigate the safety of Neuro-Cells in 10 end stage
      (chronic) traumatic spinal cord injury (TSCI) patients, when administered once intrathecally.
      TSCI is a rare disease without cure perspectives and Neuro-Cells is an autologous fresh stem
      cells containing product (one batch / one patient).
    

Detailed description: 
      This phase I clinical study is an open clinical trial to investigate the safety of the
      intrathecal application of Neuro-Cells in the treatment of end stage (chronic), traumatic
      complete (AIS grade A) and incomplete (AIS grade B/C) SCI patients. To that purpose, after
      inclusion in this study >1 year and less than 5 years after their SCI-event, 10 patients will
      be included. All patients are invited to visit the trial hospital every month during this
      3-months study for appreciation of their possible (S)AEs and/or SUSARs, for physical
      examination and a biochemical analysis of their blood/urine. Day 0 and day 90 they also
      undergo a comprehensive neurological examination, the AISIAms, ASIAss and Pain perception.

      Finally, the participants are also invited to undergo neurological examinations at day 360
      and 720. The purpose of this neurological assessment is to explore in patients if a late
      administration of Neuro-Cells may have some beneficial effects on the neurological condition
      of the chronic SCI patient.

      All patients undergo a BM harvesting at the start of their participation in the study and
      will undergo one LP, performed to administer Neuro-Cells. The study is open and descriptive,
      and no randomization takes place. All patients are followed up until approximately 3 months
      after the time of administration. After these 3 months, the safety part of this study ends.
      Patients are invited for a neurological assessment 9 months later (day 360) to explore if
      Neuro-Cells may have a beneficial effect when given to end stage patients with a traumatic
      SCI.

      The safety part of the study is completed when the last patient finishes his/her visit at day
      90. The explorative part of the study ends approximately one year after the time of inclusion
      at day 720.
    

Intervention name(s): Neuro-Cells
Intervention type(s): Biological
Intervention description(s): Neuro-Cells is an autologous fresh stem cells containing product which modulates the secondary inflammation following a TSCI, reduces apoptosis (cell death) in the injured spinal cord, reduces scar tissue formation in the damaged spinal cord and creates a cell regenerative environment in the injured spinal cord.
Intervention model: Single Group Assignment
Intervention model description: TSCI patients are treated once at start of the study and followed up for 3 months to characterize and confirm safety of intrathecal administration of Neuro-Cells.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Traumatic Spinal Cord Injury; Stem Cells