Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury

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.

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.

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