A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)

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