Trial Outcomes & Findings for A Study of Modified Stem Cells in Stable Ischemic Stroke (NCT NCT01287936)

A Study of Modified Stem Cells in Stable Ischemic Stroke

Number of subjects with TEAEs by maximum severity. The severity of all AEs was assessed by the Investigator using the World Health Organization (WHO) Toxicity Scale. For abnormalities not found elsewhere in the WHO table, the following scale was used to assign severity: Mild: Transient mild discomfort; no limitation in activity; no medical intervention/therapy required. Moderate: Mild-to-moderate limitation in activity; some assistance may be need. No or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required; hospitalization or prolongation of current hospitalization possible. Life-threatening: Extreme limitation in activity, significant assistance required; significant medial intervention/therapy required; hospitalization or prolongation of current hospitalization or hospice care probable.

The ESS is the sum of 14 items that are used to assess a patient who has recently had a stroke. These 14 items are level of consciousness, comprehension, speech, visual field, gaze, facial movement, arm in outstretched position, arm raising, extension of the wrist, fingers, leg maintained in position, leg flexing, dorsiflexion of the foot, and gait. A certain number of points are given for each parameter. The range of the total score of ESS is 0 - 100, with a completely normal person having a score of 100 and maximally affected person with a score of zero.

The ESS motor function score is a sum of the selected items: facial movement, arm in outstretched position, arm raising, extension of wrist, fingers, leg maintained in position, leg flexing, dorsiflexion of foot, and gait. A completely normal person will have a score of 66. The maximally affected person will have a score of zero.

The NIHSS is a standardized method used to measure the level of impairment caused by a stroke. The scale consists of 11 items that measure several aspects of brain function, including consciousness, vision, sensation, movement, speech, and language. A certain number of points are given for each impairment uncovered during a focused neurological examination. A maximal score of 42 represents the most severe and devastating stroke with 0=no stroke, 1-4=minor stroke, 5-15=moderate stroke, 15-20=moderate/severe stroke, and 21-42=severe stroke.

The NIHSS is a standardized method used to measure the level of impairment caused by a stroke. The NIHSS Motor Function Total Score consists of 3 items: motor arm, motor leg, and limb ataxia, with 0 = no stroke and a maximal score of 18 = most severe impairment for motor function.

The mRS is a commonly used scale for measuring the degree of disability in daily activities for patients who have suffered a stroke. The mRS is an ordinal scale from 0 (no symptoms at all) to 5 (severe disability; requiring constant nursing care and attention, bedridden, incontinent) with a sixth category of death.

The Fugl-Meyer Scale is a stroke-specific, performance-based impairment index. The scale is comprised of 5 domains (motor score, sensation, balance, joint range of motion, and joint pain) with 155 items in total. Scoring is based on direct observation of performance. Scale items in all 5 domains are scored on the basis of ability to complete the item using a 3-point Likert-type ordinal scale, where 0=cannot perform, 1=performs partially, and 2=performs fully. Points are divided among the domains: (a) Motor performance \[0 (hemiplegia) - 100 (normal motor performance) points\]; (b) Balance \[0-14 points: 6 for sitting; 8 for standing\]; (c) Sensation \[0-24 points: 8 for light touch; 16 for position sense\]; (d) Joint range of motion \[0-44 points\]; (e) Joint pain \[0-44 points\]. For all domains, a maximally affected person will score 0 while a fully functional person will have the highest score. All items are summed to provide a minimum score of 0 and a maximum score of 226.

The FMMS is used as a clinical measure of body function impairment after stroke that assesses several dimensions of motor impairment, including range of motion in upper and lower limbs, reflex activity, volitional movement, and coordination. The FMMS motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance), and is comprised of a 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale: 0= cannot perform; 1= partial motion; 2= full motion Individual items are summed to determine scores for the 2 subscale scores, as well as a motor total score (total of the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. A maximally affected person will have a score of 0 while a fully functional person will have the highest score (i.e., 34 for LE-FMMS, 66 for UE-FMMS, 100 for FMMS)

The Fugl-Meyer Upper Extremity subscale (UE-FMMS) is comprised of 33 items that assess several dimensions of motor impairment, including range of motion in upper limbs, reflex activity, volitional movement, and coordination. Scoring is based on direct observation of performance and is scored using a 3-point ordinal scale, where 0=cannot perform; 1=partial motion; and 2=full motion Individual items are summed to provide ranging from 0 (minimum) to 66 (maximum). A maximally affected person will have a score of 0 while a fully functional person will a score of 66.

The Fugl-Meyer Lower Extremity subscale (LE-FMMS) is comprised of 17 items that assess several dimensions of motor impairment, including range of motion in lower limbs, reflex activity, volitional movement, and coordination. Scoring is based on direct observation of performance and is scored using a 3-point ordinal scale, where 0=cannot perform; 1=partial motion; and 2=full motion Individual items are summed to provide ranging from 0 (minimum) to 34 (maximum). A maximally affected person will have a score of 0 while a fully functional person will a score of 34.