Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI
About this trial
This is a study to test the safety and effect of transplanting a type of stem cell (neural precursor) into the spinal cord of individuals with recent complete, cervical (neck area) spinal cord injury. The stem cells are derived from human embryos. The number of cells transplanted will be gradually increased as the study proceeds. Subsequent progress of individuals with transplants will be monitored by clinic visits; final testing will be performed after 1 year and 5 months.
Included participants
Traumatic
What’s involved
Type
Details
The first few individuals will receive surgery for the transplantation of “PSA-NCAM(+) NPC” injected into the “intrathecal” space around the spinal cord. If the first individuals at a given “dose” of cells do not develop any side effects, additional individuals will be included and receive the transplantation. The number of cells (dose) will be gradually increased as new individuals are included, as long as there are no adverse effects noted. Re-examination and testing will be performed at weeks 1, 2, 4, 8, 12, 24, 48, and 72 after surgery. This will include neurological testing, blood testing and Magnetic Resonance Imaging (MRI) of the spinal cord.
Potential benefits
Main benefits
General health
Additional benefits
Arm/hand function
Pain
Sensory function
Standing/walking/mobility
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- Recruiting
- Trial start date
- 23 Sep 2021
- Organisation
- S.Biomedics Co., Ltd.
- Trial recruitment status
- Recruiting
- Trial start date
- 23 Sep 2021
- Organisation
- S.Biomedics Co., Ltd.
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more