The purpose of this study is to evaluate the safety and effectiveness of a suspension of SB623 cells administered by injection around an area of traumatic injury in the brain. SB623 is derived from modified stem cells obtained from bone marrow of another adult human. Approximately 52 participants will be enrolled in this study at multiple sites in the United States and Japan. The administration of these cells is considered “investigational” because it has not received approval from the Food and Drug Administration.
SB623 cells are derived from modified stem cells obtained from bone marrow of another adult human. It is believed that SB623 cells release factors that protect neurons and promote cell growth in the recipient’s brain. A study of surgical delivery of the SB623 cells was evaluated with stroke patients and found to have an acceptable safety profile.
In order to understand whether the surgical delivery of SB623 cells has an effect on the functioning of patients with traumatic brain injury, some participants in this study will undergo surgery but not actually have the SB623 cells injected into their brain. This procedure is known as a “control surgery”, and is done to test the “placebo effect,” meaning that patients might perceive improvement in their symptoms because they underwent the surgery, rather than because the injected cells had a beneficial effect. Participants have a one in three chance of being assigned to receive the control surgery. Neither the participant or the study doctor will know whether they were assigned to receive SB623 or the control surgery.
Participants are invited to take part in this research study if they are older than 18 years and have been diagnosed with a persistent motor deficit (e.g. arm or leg weakness) from a traumatic brain injury (TBI) and the TBI was caused by an injury to the head at least 12 months ago.
A description of this clinical trial will be available on clinicaltrials.gov.
At present, this study is closed to enrollment. A phase 3 trial is in the works.