외상성 뇌손상 및 저산소-허혈성 뇌병증 치료를 위한 희망바이오사이언스 자가 중간엽 줄기세포 치료의 안전성 및 유효성을 결정하기 위한 임상 시험

HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Respiratory Rate

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Temperature

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Systolic Blood Pressure

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Diastolic Blood Pressure

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Pulse Rate

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Oxygen Saturation

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Diastolic Blood Pressure

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Systolic Blood Pressure

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Pulse Rate

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Oxygen Saturation

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Respiratory Rate

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Temperature

IL-4 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values ranged from 1940 pg/mL to 6060 pg/mL

IL-2 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values ranged from 363 pg/mL to 1909 pg/mL

IL-1-beta lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values range from 1615 pg/mL to 6930 pg/mL

IP-10 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values ranged from 5270 pg/mL to 15466 pg/mL

TNFα lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values ranged from 232 pg/mL to 4570 pg/mL

MCP-1 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values range from 1439 pg/mL to 7472 pg/mL

IL-17a lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values measure 526 pg/mL to 3228 pg/mL

IL-6 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values range from 750 pg/mL to 4740 pg/mL

IL-10 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values range from 497 pg/mL to 2796 pg/mL

IFN-gamma lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values range from 764 pg/mL to 6591 pg/mL

IL-12p70 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values range from 676 pg/mL to 3975 pg/mL

IL-8 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values range from 1348 pg/mL to 7738 pg/mL

Free active TGF-Beta1 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Values range from 799 pg/mL to 7374 pg/mL

Count of Participants with specific GOS-E scores at Visits 3, 6, and 7 Glasgow Outcome Scale-Extended is an 8-point scale that classifies the global outcome for individuals with traumatic brain injury (TBI), ranging from 1 (dead) to 8 (upper good recovery). The categorical rating is based on a structured interview about the patient's ability to function. Higher scores indicate better recovery. Category 3 is Lower Severe Disability, Category 4 is Upper Severe Disability, Category 5 is Lower Moderate Disability, and Category 6 is Upper Moderate Disability.

Mean and SD of Disability Rating Scale (DRS) evaluation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Disability Rating Scale score provides a numerical measure of an individual's functional impairment and disability. This assessment uses a 0-30 total score to assess traumatic brain injury, with higher scores indicating greater disability. A score of 0 indicates a rating of "no disability" and a score of 30 indicates a rating of "profound vegetative state".

Mean and SD of Galveston Orientation and Amnesia Test (GOAT) evaluation of cognition at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The total score is calculated by subtracting an "error score" from 100. The error score is calculated by summing together the individual error score points from each question. The minimum total score of -3 is associated with a failure to respond correctly to any memory/orientation question. A total score of 100 indicates perfect recall on the GOAT memory/orientation questions. Higher total scores indicate better recall.

Brief Symptoms Inventory 18 (BSI 18) Somatization (SOM) T-Score Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.

Brief Symptoms Inventory 18 (BSI 18) Depression (DEP) T-Score Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.

Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.

Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. The Global Severity Index (GSI) is the sum of the three subscores, which was then normalized with a t-score in this analysis. A T-score was calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.

TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.

TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.

TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.

TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.

TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction with SRA T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.

TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.

NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.

NIH Toolbox - Cognition: Picture Vocabulary Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.

NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.

NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.

NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.

NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.

NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.

Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Rey Auditory Verbal Learning Test (RAVLT) Delay Test consists of calculating the total number of words recalled on the delayed recall trial (after a 20-30 minute delay). Then, a T-score is calculated by comparing to normative data adjusted for age and education to determine performance relative to peers. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more words were recalled (better outcomes). Technically there is no minimum or maximum t-score since it is normalized.

Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 Test consists of calculating the total number of words correctly recalled across the five initial learning trials (Trials 1-5). Then, a T-score is calculated by comparing to normative data adjusted for age and education to determine performance relative to peers. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more words were recalled (better outcomes). Technically there is no minimum or maximum t-score since it is normalized.

Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of "Average" being 90-109, "High Average" 110-119, "Low Average" 80-89, "Borderline" 70-79, and "Extremely Low" below 70. Higher scores mean better outcome.

Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of "Average" being 90-109, "High Average" 110-119, "Low Average" 80-89, "Borderline" 70-79, and "Extremely Low" below 70. Higher scores mean better outcome.

Wechsler Adult Intelligence Scale - IV: Processing Speed Composite Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of "Average" being 90-109, "High Average" 110-119, "Low Average" 80-89, "Borderline" 70-79, and "Extremely Low" below 70. Higher scores mean better outcome.

Controlled Oral Word Association Test (COWAT) Total Scaled Scores Mean and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The COWAT is scored by counting the number of correct words a person produces in one minute for each of the three given letters. The total score is the sum of the unique words generated across all three trials. Higher scores are considered a better outcome. The raw total score is then compared to normative data that is based on factors such as age and education level. The scaled score has a mean of 10 and a standard deviation of 3. A t-score of < 20 indicates severe impairment.

MRI Structural Measures - Global White Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Global Gray Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Global Corpus Callosum Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Hippocampus (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Amygdala (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Thalamus (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Caudate (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Putamen (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Pallidum (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Insula (Bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Hippocampus (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Hippocampus (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Amygdala (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Amygdala (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Thalamus (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Thalamus (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Caudate (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Caudate (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Putamen (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Putamen (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Pallidum (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Pallidum (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Insula (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.

MRI Structural Measures - Insula (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.