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

WHOM in stroke is going to followup testing in stroke patients? Or do we have NO LEADERS IN STROKE?

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

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)
Actual Enrollment :	61 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)
Actual Study Start Date :	June 24, 2016
Actual Primary Completion Date :	January 31, 2019
Actual Study Completion Date :	March 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Traumatic Brain Injury

U.S. FDA Resources

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 ]