A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Intervention: SB623 cells; Sham Control
Intervention description: SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.; Sham Surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary purpose of the clinical study is to evaluate the clinical efficacy of
      intracranial administration of SB623 cells on patients with chronic motor deficit from
      Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of
      intracranial administration of SB623 cells on disability parameters and 2) to evaluate the
      safety and tolerability of intracranial administration of SB623 cells. Patients with stable,
      chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented history of TBI, with correlated MRI or CT

          -  At least 12 months post-TBI

          -  Focal cerebral injury able to be identified on MRI (+/- concomitant diffuse axonal
             injury)

          -  Neurological motor deficit substantially due to focal cerebral injury observed on MRI

          -  GOS-E score of 3-6 (i.e. moderate or severe disability)

          -  Require Motricity Index 10-81 (UE Scale) and/or 10-78 (LE Scale)

          -  Able and willing to undergo computed tomography (CT) and magnetic resonance imaging
             (MRI)

          -  Subjects must be willing to participate in study related exercises to the extent
             possible

          -  Able to undergo all planned neurological assessments

        Exclusion Criteria:

          -  History or presence of any other major neurological disease

          -  Any seizures in the prior 3 months

          -  The presence of contracture at any joints that would interfere with interpretation of
             any of the neurological assessments (e.g. contracture preventing the detection of any
             increase in the range of motion or ability to perform a task)

          -  Other neurologic, neuromuscular or orthopedic disease that limits motor function

          -  Clincially significant finding on MRI of brain not related to TBI

          -  Known presence of any malignancy except squamous or basal cell carcinoma of the skin

          -  History of CNS malignancy

          -  Positive findings on tests for occult malignancy, unless a non-malignant etiology is
             confirmed

          -  Uncontrolled systemic illness, including, but not limited to: hypertension (systolic
             >150 mm Hg or diastolic >95 mm Hg); diabetes; renal, hepatic, or cardiac failure

          -  Uncontrolled major psychiatric illness, including depression symptoms (CESD-R Scale of
             ≥16)

          -  Unexplained abnormal preoperative test values (blood tests, electrocardiogram [ECG],
             chest X-ray); x-ray evidence of infection; uncontrolled atrial fibrillation or
             uncontrolled congestive heart failure

          -  Presence of craniectomy (without bone flap replacement) or other contraindication to
             stereotactic surgery

          -  Participation in any other investigational trial within 4 weeks of initial screening
             or within 7 weeks of study entry

          -  Botulinum toxin injection, phenol injection, intrathecal baclofen, or any other
             interventional treatments for spasticity (except bracing and splinting) 16 weeks priot
             to the Baseline visit.

          -  Ongoing use of other non-traditional drugs

          -  Substance use disorder (per DSM-V criteria, including drug or alcohol)

          -  Contraindications to head CT or MRI

          -  Pregnant or lactating

          -  Female patients of childbearing potential unwilling to use an adequate birth control
             method during the 12 months of the study