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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Mesenchymal stem cells transplantation
Asan medical center
Seoul, South Korea
Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale
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
Time frame: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
Sensory score of the American Spinal Injury Association (ASIA) scale
Analyze the difference between the pre and post of the ASIA sensory score by using the Study's pre-test (Wilcoxon's signed test). \<American Spinal Injury Association (ASIA) scale\> The exam is based on neurological responses, touch and pinprick sensations tested in each dermatome, and strength of the muscles that control key motions on both sides of the body. Sensation is graded on a scale of 0-2: 0 is no sensation, 1 is altered or decreased sensation, and 2 is full sensation. Each side of the body is graded independently. When an area is not available (e.g. because of an amputation or cast), it is recorded as "NT", "not testable".
Time frame: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
Electrophysiological change (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP)
Post 6 months of treatment, the validity is analyzed through patients who have expressed their responses to the electrophysiological test (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months
MRI and Diffusion Tensor Imaging of spinal cord
Post 6 months of cell treatment, the ratio of patients with changes in magnetic resonance imaging is analyzed.
Time frame: 6 months