A Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Chronic Spinal Cord Injury.
Overview
- Phase
- Phase 2
- Intervention
- cellgram-spine
- Conditions
- Spinal Cord Injury
- Sponsor
- Pharmicell Co., Ltd.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
This phase II/III clinical trial is designed to evaluate the safety and efficacy of autologous Mesenchymal Stem Cells (MSC) transplanted directly into the injured spinal cord.
Detailed Description
The Principal investigator has performed a clinical trial using autologous MSCs in patients with cervical spinal cord injury. The results revealed the safety of autologous MSC. This Phase II, III single-center trial is to assess the safety and efficacy of bone marrow-derived mesenchymal stem cell transplantation direct to injured spinal cord site via laminectomy. After recovery from the operation, the subjects receive 4 weeks of physical and occupational therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged between 16-65 years
- •Traumatic spinal cord injury at the level of cervical
- •American Spinal Injury Association Impairment Scale B
- •12 months or more post spinal cord injury subject with stable neurological finding after more than 1 month rehabilitation therapy
- •No signs of contracture
- •Good physical condition to go through operation
- •Must be willing and able to participate in study procedures with no mental and verbal problem
- •Able to consent by patients or legal representatives
Exclusion Criteria
- •Serum SGOT/SGPT \> 3 X upper limit of normal or Creatinine \> 1.5 X upper limit of normal
- •Major surgical procedure in the past 3 months
- •Penetrating injury
- •Mechanical ventilation
- •Serious pre-existing medical conditions
- •Recently diagnosed infection (Urinary tract infection, Pneumonia etc)
- •Positive skin test for penicillin
- •Positive result for viral markers (human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and Venereal Disease Research Laboratory (VDRL) test)
- •Pregnant women, women of childbearing potential who do not want adequate contraception, breastfeeding females
- •Unwilling to participate in study
Arms & Interventions
cellgram-spine
posterior cervical laminectomy and Mesenchymal stem cells tranplantation. After laminectomy, 1.6X10\^7 and 3.2 X10\^7 Autologous Mesenchymal stem cells is injected into the intramedullary and intrathecal space respectively
Intervention: cellgram-spine
Outcomes
Primary Outcomes
Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale
Time Frame: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
Compared Baseline and after 6, 12 months of cell treatment, ASIA motor test analyzes the proportion of patients with a motor grade of more than 2 devision, with a motor grade improving from 2 to 3 and a rise of 5 or more in total score. \<American Spinal Injury Association (ASIA) scale\> 0 Total paralysis 1. Palpable or visible contraction 2. Active movement, full Range Of Motion(ROM) with gravity eliminated 3. Active movement, full ROM against gravity 4. Active movement, full ROM against gravity and moderate resistance in a muscle specific position 5. (normal) Active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person 5\* (normal) Active movement, full ROM against gravity and sufficient resistance to be considered normal if identified inhibiting factors (i.e. pain, disuse) were not present NT Not testable
Secondary Outcomes
- Electrophysiological change (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP)(6 months)
- Sensory score of the American Spinal Injury Association (ASIA) scale(Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month)
- MRI and Diffusion Tensor Imaging of spinal cord(6 months)