Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI
This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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. ] [ Designated as safety issue: Yes ]The primary outcome measure is the incidence of adverse events in the study population.
- 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. ] [ Designated as safety issue: Yes ]The secondary outcome measures of the study are to evaluate graft survival in the transplant site and to determine the effectiveness of immunosuppression as determined by absence of donor-specific HLA antibodies.
- Exploratory Outcome Measures [ Time Frame: The exploratory outcome measures of the study will be assessed over a 60 month period. ] [ Designated as safety issue: Yes ]The exploratory outcome measure of the study is to compare baseline sensory and motor index scores to post HSSC transplantation sensory and motor index scores. Baseline bowel and bladder function scores compared to the bowel and bladder function scores post transplantation. Baseline evoked sensory or motor potentials or EMG compared to post transplantation evoked potentials or EMG.
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Experimental: Surgical implantation of human spinal cord stem cells
Surgical implantation of human spinal cord derived neural stem cells.
Device: Human spinal cord stem cells.
Human spinal cord stem cell implantation in paralysis patients due to a spinal cord injury.
Other Name: spinal cord injury (SCI)
This is a Phase I, open-label, multi-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. There will be a 4-week interval between the first two subjects and a minimum of 2-week interval between patients. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772810
|Contact: Amber Faulise, B.S.||firstname.lastname@example.org|
|United States, California|
|UCSD Medical Center, Division of Neurosurgery||Recruiting|
|San Diego, California, United States, 92103-8893|
|Contact: Joseph Ciacci, MD email@example.com|
|Contact: Martin Marsala, MD firstname.lastname@example.org|
|Principal Investigator: Joseph Ciacci, MD|
|Sub-Investigator: Martin Marsala, MD|