Last updated on May 2018

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

Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02416492

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Daniel Lu, MD

UCLA Medical Center (Surgical/Assessment)
Los Angeles, CA United States

Benjamin Frishberg, MD

The Research Center of Southern California, LLC (Assessment)
Oceanside, CA United States

Leonid Groysman, MD

University of California, Irvine (Assessment/Surgical)
Orange, CA United States

Albert Lai, MD

Westview Clinical Research (Assessment)
Placentia, CA United States

Gary Steinberg, MD

Stanford Health Care (Surgical/Assessment)
Stanford, CA United States

Peter McAllister, MD

Ki Health Partners, LLC dba New England Institute for Clinical Research (Assessment)
Stamford, CT United States

Husham Mishu, MD

Midtown Neurology, PC (Assessment)
Atlanta, GA United States

Robert E Gross, MD, PhD

Emory University Hospital (Surgical)
Atlanta, GA United States

Douglas Kondziolka, MD

NYU Langone Medical Center (Surgical/Assessment)
New York, NY United States

Barry Jordan, MD

Burke Rehab Center (Assessment)
White Plains, NY United States

Thomas Watanabe, MD

Moss Rehab (Assessment)
Elkins Park, PA United States

David O Okonkwo, MD, PhD

University of Pittsburgh Medical Center (Surgical/Assessment)
Pittsburgh, PA United States

Istvan Takacs, MD

Medical University of South Carolina (Surgical)
Charleston, SC United States

Masahito Kawabori, MD, PhD

Hokkaido University Hospital (Surgical/Assessment)
Sapporo, Japan

Jun Suenaga, MD, PhD

Yokohama City University Hospital (Surgical/Assessment)
Yokohama, Japan

Takao Yasuhara, MD, PhD

Okayama University Hospital (Assessment/Surgical)
Okayama-shi, Japan

Hajime Nakamura, MD, PhD

Osaka University Hospital (Assessment/Surgical)
Suita, Japan

Masahiro Shin, MD, PhD

University of Tokyo Hospital (Assessment/Surgical)
Bunkyo, Japan

Santosh Kesari, MD

Providence Saint John's Health Center
Santa Monica, CA United States

Alan Weintraub, MD

Craig Hospital
Englewood, CO United States

Adonis Maiquez, MD

SouthCoast Research Center
Miami, FL United States

David Ripley, MD

Rehabilitation Institute of Chicago
Chicago, IL United States

Janet Bay, MD

Ohio Health Research
Columbus, OH United States

James McGowan, MD

Virginia Commonwealth University
Richmond, VA United States

Lucien Megna, MD

Mid-Columbia Research
Richland, WA United States

Ihor Semeniv, MD

Clinical Hospital Feofaniia
Kiev, Ukraine

Recruitment Status: Closed

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