Spinal Cord Injury
Conditions
Keywords
spinal cord injury, mesenchymal stem cell
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.
Interventions
DRUGcellgram-spine
Mesenchymal stem cells transplantation
Sponsors
Pharmicell Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
posterior cervical laminectomy and Mesenchymal stem cells(cellgram-spine) tranplantation. After laminectomy, 1.6X107 and 3.2 X107 Autologous Mesenchymal stem cells is injected into the intramedullary and intrathecal space respectively
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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 * Patients with psychiatric disorder severe as to make compliance with the treatment unlike, and signing informed consent impossible * Drug abuse in the past 1 year * Participating in other clinical trials in the past 1 month * Inappropriate patients to participate in the study according to the chief investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensory score of the American Spinal Injury Association (ASIA) scale | Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month | 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. |
| Electrophysiological change (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP) | 6 months | 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). |
| MRI and Diffusion Tensor Imaging of spinal cord | 6 months | Post 6 months of cell treatment, the ratio of patients with changes in magnetic resonance imaging is analyzed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | Baseline to 12 months | Analyze the laboratory, vital sign, ECG, physical exam, medical exam, chest X-ray results from baseline to end of the study for investigate adverse reactions and view safety. |
Countries
South Korea
Outcome results
None listed