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
Secondary Outcome Measures :
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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
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 :
- 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 :
- Change in Disability Rating
Scale (DRS) score [ Time Frame: Change from baseline in Disability
Rating Scale (DRS) score at Month 6 ]
- 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 ]
- Change in Gait Velocity [ Time Frame: Change from baseline in Gait Velocity at Month 6 ]
- 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) ]
- Global Rating of Perceived Change scores [ Time Frame: Global Rating of Perceived Change scores at Month 6 from baseline ]
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