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

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ClinicalTrials.gov Identifier: NCT02416492
Recruitment Status : Active, not recruiting
First Posted : April 15, 2015
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
SanBio, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Biological: SB623 cells Procedure: Sham Control Phase 2

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : January 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SB623 Cells
SB623 Cells: 2.5, 5 or 10 million cells surgically implanted adjacent to the injured cerebral region.
 Biological: SB623 cells
SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.
Sham Comparator: Sham Surgery
Control Sham Surgery (partial burr hole only)
 Procedure: Sham Control
Sham Surgery (Partial burr hole only)


Outcome Measures
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Primary Outcome Measures :
  1. Change in Fugl-Meyer Motor Scale (FMMS) [ Time Frame: Change from baseline in Fugl-Meyer Motor Scale (FMMS) score at Month 6 ]

Secondary Outcome Measures :
  1. Change in Disability Rating Scale (DRS) score [ Time Frame: Change from baseline in Disability Rating Scale (DRS) score at Month 6 ]
  2. Change in Action Research Arm Test (ARAT) total score [ Time Frame: Change from baseline in Action Research Arm Test (ARAT) total score at Month 6 ]
  3. Change in Gait Velocity [ Time Frame: Change from baseline in Gait Velocity at Month 6 ]
  4. Change from baseline in T scores of NeuroQOL Domains -- Upper Extremity Function (Fine motor ADL) and Lower Extremity Function (Mobility) [ Time Frame: Change from baseline in T scores at Month 6 of NeuroQOL Domains -- Upper Extremity Function (Fine motor ADL) and Lower Extremity Function (Mobility) ]
  5. Global Rating of Perceived Change scores [ Time Frame: Global Rating of Perceived Change scores at Month 6 from baseline ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416492


  Show 26 Study Locations
Sponsors and Collaborators
SanBio, Inc.
Investigators
Principal Investigator: Daniel C Lu, MD, PhD University of California, Los Angeles, Department of Neurosurgery
More Information
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Responsible Party: SanBio, Inc.
ClinicalTrials.gov Identifier: NCT02416492     History of Changes
Other Study ID Numbers: TBI-01
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System