Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI
This trial is active, not recruiting.
|Condition||spinal cord injury (sci)|
|Treatment||human spinal cord stem cells.|
|Start date||August 2014|
|End date||February 2016|
|Trial size||4 participants|
|Trial identifier||NCT01772810, NS2010-1|
This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Surgical implantation of human spinal cord derived neural stem cells.
The primary outcome measure of the study is to determine the incidence of Adverse Events including serious adverse events (SAEs) and clinically significant laboratory abnormalities.
time frame: The primary outcome measure will be assessed over the 6 month study period.
The secondary outcome measure of the study is to evaluate the graft survival in the transplant site as determined by MRI (with and without gadolinium contrast) and via autopsy, if one is completed.
time frame: An MRI will be performed at Visits 1, 3, 5, 7, and 11 through 22.
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: 1. Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling] and comply with the study procedures 2. Men and women 18-65 years old 3. Women must have a negative serum pregnancy test and practice an acceptable method of contraception or be of non-childbearing potential (post-menopausal for at least 2 years or who have undergone hysterectomy or oophorectomy or surgical sterilization) 4. At least 1 year but no more than 2 years from time of injury at the time of surgery 5. SCI injury classified as AIS-A complete as confirmed by the PI and a Physical Medicine and Rehabilitation doctor or other SCI Medicine board certified physician based on a complete ISNC SCI examination 6. Neurologic level of injury within cord segments T2-T12 7. Agrees to the visit schedule as outlined in the informed consent Exclusion Criteria: 1. SCI due to penetrating trauma such as gun shot or stabbing wound 2. SCI injuries involving complete spinal cord transection 3. Etiology of paraplegia or weakness related to other or additional neurologic process 4. Receipt of any investigational drug or device within 30 days prior to surgery 5. Receipt of any cell infusion other than blood transfusion 6. Presence of any of the following conditions: 1. Current drug abuse or alcoholism 2. Unstable medical conditions 3. Unstable psychiatric illness including psychosis and untreated major depression 7. Any condition that the Investigator or primary physician feels may interfere with participation in the study 8. Any condition that the surgeon feels may pose complications for the surgery 9. Inability to provide informed consent as determined by screening protocol.
|Official title||A Phase 1, Open-label, Single-site, Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI|
|Description||This is a Phase I, open-label, single-site, safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury (SCI) defined as at least one year but no more than 2 years after traumatic SCI. A maximum of 4 subjects with chronic SCI with American Spinal Injury Association Impairment Scale (AIS) A who meet eligibility criteria will be enrolled. No control group will be included. All subjects will receive spinal cord injections of HSSC: Group A: 4 patients with T2-T12 cord injury. An independent Data Safety Monitoring Board (DSMB) will be convened at approximately 1 month (4 weeks) intervals after the first subject and will review all available safety data for all treated subjects. Study duration will be for 6 months for each subject. Post study, all subjects will be followed for additional 54 months by bi-annual visits during which safety assessments will be conducted as specified in the protocol.|
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