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

Completed · Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT02416492

Run by

SanBio, Inc.

People needed

63

Starts

2016-07-06

Expected to finish

2019-03-05

Last updated by the study team

2021-12-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• UCLA Medical Center (Surgical/Assessment) — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Denter — Los Angeles, California, United States
• The Research Center of Southern California, LLC (Assessment) — Oceanside, California, United States
• University of California, Irvine (Assessment/Surgical) — Orange, California, United States
• Westview Clinical Research (Assessment) — Placentia, California, United States
• Providence Saint John's Health Center — Santa Monica, California, United States
• John Wayne Cancer Institute at Providence St. Johns Health Center — Santa Monica, California, United States
• Stanford Health Care (Surgical/Assessment) — Stanford, California, United States
• Craig Hospital — Englewood, Colorado, United States
• Ki Health Partners, LLC dba New England Institute for Clinical Research (Assessment) — Stamford, Connecticut, United States
• SouthCoast Research Center — Miami, Florida, United States
• Midtown Neurology, PC (Assessment) — Atlanta, Georgia, United States
• Emory University Hospital (Surgical) — Atlanta, Georgia, United States
• Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• Shirley Ryan Ability Lab — Chicago, Illinois, United States
• NYU Langone Medical Center (Surgical/Assessment) — New York, New York, United States
• New York University Langone Medical Center — New York, New York, United States
• Burke Rehab Center (Assessment) — White Plains, New York, United States
• Ohio Health Research — Columbus, Ohio, United States
• Moss Rehab (Assessment) — Elkins Park, Pennsylvania, United States
• University of Pittsburgh Medical Center (Surgical/Assessment) — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina (Surgical) — Charleston, South Carolina, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Mid-Columbia Research — Richland, Washington, United States

Full record on ClinicalTrials.gov

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