Summary

for people ages 18-75 (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

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.

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)

Details

SB623 cells are adult bone-marrow-derived cells that are transiently transfected with a plasmid construct encoding the intracellular domain of human Notch-1. These cells produce trophic factors that protect neurons in models of ischemic insult. In a rat contusion model of TBI, implantation of SB623 around the area of the injury resulted in significant improvement of motor function. Further, safety evaluation of animal models implanted with SB623 cells have shown no adverse effects and no SB623-related clinical, laboratory, or histological abnormalities were found. A 2-year Phase 1/2A dose escalation study (NCT01287936) of SB623 stereotactically implanted into the brains of patients with chronic motor deficits due to ischemic stroke has completed.The study has shown statistically-significant improvements in motor function in each of three scales: the European Stroke Scale (ESS), the National Institute of Health Stroke Scale (NIHSS) and the Fugl-Meyer scale. The study showed no serious adverse events likely attributed to SB623, and only minor adverse events mostly grade 1 or 2 (with one grade 3) that were unrelated, unlikely related, or possibly related to SB623. No dose-limiting toxicities were observed.

Keywords

Traumatic Brain Injury Wounds and Injuries Brain Injuries Brain Injuries, Traumatic SB623 cells

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Irvine (Assessment/Surgical)
    Orange California 92868 United States
  • Westview Clinical Research (Assessment)
    Placentia California 92870 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SanBio, Inc.
ID
NCT02416492
Phase
Phase 2
Study Type
Interventional
Last Updated