Clinical trial NCT01676441: Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
mesenchymal stem cell
Lead sponsor: Pharmicell Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale
timeFrame: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
Secondary outcomes:
measure: Sensory score of the American Spinal Injury Association (ASIA) scale
timeFrame: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
measure: Electrophysiological change (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP)
timeFrame: 6 months
measure: MRI and Diffusion Tensor Imaging of spinal cord
timeFrame: 6 months
Other outcomes:
measure: Number of adverse events
timeFrame: Baseline to 12 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
affiliation: Asan Medical Center
name: Sangryong Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park JH, Kim DY, Sung IY, Choi GH, Jeon MH, Kim KK, Jeon SR. Long-term results of spinal cord injury therapy using mesenchymal stem cells derived from bone marrow in humans. Neurosurgery. 2012 May;70(5):1238-47; discussion 1247. doi: 10.1227/NEU.0b013e31824387f9.