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

Not Recruiting

Trial ID: NCT02416492


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.

Official Title

A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Traumatic Brain Injury (TBI)

Stanford Investigator(s)

Gary K. Steinberg, MD, PhD
Gary K. Steinberg, MD, PhD

Bernard and Ronni Lacroute-William Randolph Hearst Professor of Neurosurgery and Neurosciences and Professor, by courtesy, of Neurology


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

   - 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

   - Subjects must be willing to participate in study related exercises to the extent

   - 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

   - 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

   - 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


biological: SB623 cells

procedure: Sham Control

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Guiping Qin