Autologous Adipose Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Autologous Adipose Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951777
• Other study ID #: HBTBI02
• Status: Recruiting
• Phase: Phase 2
• Start date: April 16, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Hope Biosciences
• Contact: Carmen Duron, RN, MHA, BSN
• Phone: 713-500-7395
• Email: Maria.Carmen.Duron[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury and/or hypoxic-ischemic encephalopathy in adults.

Description:

This study is a prospective, randomized, double-blind, placebo-controlled Phase 2a study of three infusions of autologous HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) (2 x 10^8 total cells per dose) administered over a 6 week period with 14 day intervals between infusions. Subjects will be monitored and assessed for infusion related toxicity for the first 4hr. after the infusion and by telephone 24hr. after each infusion. Safety assessments will be conducted at the study follow-up clinic visits 6 and 12 months, and 2 years (telephone call) after the last HB-adMSC (Hope Biosciences adipose-derived mesenchymal stem cells) infusion, or more frequently if infusion related adverse events are suspected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Adults between 18 and 55 years of age.

2. Documented functional neurological damage to the central nervous system from closed head trauma that is unlikely to improve with present standard of care approaches.

3. A Glasgow Outcome Scale-Extended (GOS-E) score >2 and =6.

4. Onset or diagnosis of the injury or disease process greater than 6 months.

5. Ability to obtain consent from the subject or their legally authorized representative (LAR).

6. Ability to communicate in English or Spanish (required for validated neurocognitive outcome testing).

Exclusion Criteria:

1. Known history of: a) intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior; b) recently treated infection; c) renal disease or altered renal function (screening eGFR (estimated glomerular filtration rate) > 60 mL/min/1.73m2); d) hepatic disease or altered liver function (screening SGPT (serum glutamate pyruvate transaminase) > 150 U/L or T. Bilirubin >1.3 mg/dL); e) cancer; f) immunosuppression (screening WBC (white blood cell) < 3, 000 cells/ml); g) HIV+ (human immunodeficiency virus positive); h) chemical or ETOH (Ethanol/Alcohol) dependency that in the opinion of the investigator would preclude participation in the study; i) acute or chronic lung disease requiring significant medication/oxygen supplementation; j) bleeding disorders including immune-mediated heparin-induced thrombocytopenia; k) known sensitivity to heparin, Lovenox, and pork products; l) individuals with mechanical prosthetic heart valves; m) individuals who have received a stem cell treatment.

2. Normal brain CT/MRI (computed tomography/magnetic resonance imaging) exam.

3. Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or complete spinal cord injury diagnosed by CT (computed tomography) or MR (magnetic resonance) imaging or by clinical findings.

4. Diagnosed with a genetic or metabolic disorder related to the neurologic condition.

5. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.

6. For women of child bearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study.

7. Concurrent participation in interventional drug or device study.

8. Inability to undergo the diagnostic tests (PET/DT-MRI (positron emission tomography/diffusion tensor-magnetic resonance imaging)) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.

9. Metal implants including baclofen pumps that would preclude DT-MRI (Diffusion tensor-magnetic resonance imaging).

10. Unwilling or unable to return for the follow-up study visits.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Biological:
• Autologous HB-adMSCs
Hope Biosciences autologous adipose-derived mesenchymal stem cells

Drug:
• Normal Saline
Sterile Saline Solution 0.9%

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston	Houston	Texas
United States	The University of Texas Health Science at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Hope Biosciences	The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose	clinical lab evaluation of level of glucose in the blood (mg/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Calcium	clinical lab evaluation of level of calcium in the blood (mg/dL); clinical lab evaluation of level of calcium in the blood (mg/dL) clinical lab evaluation of level of calcium in the blood (mg/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Albumin	clinical lab evaluation of level of albumin in the blood (g/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Total Protein	clinical lab evaluation of total protein in the blood (g/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Sodium	clinical lab evaluation of total sodium in the blood (mmol/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Total carbon dioxide	clinical lab evaluation of total carbon dioxide in the blood (mmol/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Potassium	clinical lab evaluation of potassium in the blood (mmol/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Chloride	clinical lab evaluation of chloride in the blood (mmol/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	BUN (blood urea nitrogen)	clinical evaluation of blood urea nitrogen (BUN) (mg/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Creatinine	clinical evaluation of creatinine in blood (mg/dL	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Alkaline phosphatase	clinical evaluation of alkaline phosphatase (ALP) in blood (IU/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Alanine aminotransferase	clinical evaluation of alanine aminotransferase (ALT) in blood (IU/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Aspartate aminotransferase	clinical evaluation of aspartate aminotransferase (AST) in blood (IU/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Total Bilirubin	clinical evaluation of total bilirubin in blood (mg/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	White blood cell	clinical evaluation of white blood cells (WBC) in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Red blood cell	clinical evaluation of red blood cells (RBC) in blood (x 10^6/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Hemoglobin	clinical evaluation of hemoglobin in blood (g/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Hematocrit	clinical evaluation of hematocrit in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Mean corpuscular volume	clinical evaluation of mean corpuscular volume (MCV) in blood (fL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Mean corpuscular hemoglobin	clinical evaluation of mean corpuscular hemoglobin (MCH) in blood (pg)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Mean corpuscular hemoglobin concentration	clinical evaluation of mean corpuscular hemoglobin concentration (MCHC) in blood (g/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Red cell distribution width	clinical evaluation of red cell distribution width (RDW) in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Neutrophils	clinical evaluation of neutrophils in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Lymphocytes	clinical evaluation of lymphocytes in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Monocytes	clinical evaluation of monocytes in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Eosinophils	clinical evaluation of eosinophils in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Basophils	clinical evaluation of basophils in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Absolute Neutrophils	clinical evaluation of absolute neutrophils in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Absolute lymphocytes	clinical evaluation of absolute lymphocytes in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Absolute monocytes	clinical evaluation of absolute monocytes in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Absolute eosinophils	clinical evaluation of absolute eosinophils in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Absolute basophils	clinical evaluation of absolute basophils in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Immature Granulocytes	clinical evaluation of immature granulocytes in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Absolute Immature Granulocytes	clinical evaluation of absolute immature granulocytes in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Platelets	clinical evaluation of platelets in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Prothrombin Time	clinical evaluation of time for blood to coagulate (seconds)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	INR (international normalized ratio)	clinical evaluation of international normalized ratio of blood coagulation (no unit)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Primary	Urine Pregnancy (if applicable)	clinical evaluation of human chorionic gonadotropin (hCG) in urine (positive/negative)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Secondary	Whole brain MRI (Magnetic resonance imaging)	DTI (Diffusion tensor imaging) to assess macro- and micro-structural properties	Baseline, change from baseline at 6 months post-infusion
Secondary	PET/DT-MRI (positron emission tomography/Diffusion tensor-Magnetic resonance imaging)	[11C]ER-176 (a Radioligand for 18-kDa (Translocator Protein)) tracer/label to identify brain proteins associated with neuroinflammatory response regulation	Baseline, change from baseline at 6 months post-infusion
Secondary	Glasgow Outcome Scale - Extended	Dichotomized-Glasgow Outcomes Score (GOSE) to evaluate affect, functional outcome, and neuropsychological function.; Minimum score = 1 = dead; 2 = vegetative state; 3 = lower severe disability; 4 = upper severe disability; 5 = lower moderate disability; 6 = upper moderate disability; 7 = lower good recovery; Maximum score = 8 = upper good recovery; Higher scores indicate better outcome.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Disability Rating Scale	Rating of level of arousal, cognitive ability related to activities of daily living, and level of functioning.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Behavior Rating of Executive Functions-Adult	Behavior Regulation and Metacognitive Indices assess everyday executive functions	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	TBI (Traumatic Brain Injury) Quality of Life Questionnaires	TBI-QOL SF (Traumatic Brain Injury-Quality of Life Short-Form) measures physical, psychological health, cognitive, and participation outcomes: Cognition: minimum raw score = 10, maximum raw score = 50. A higher score represents better functioning.; Communication/Comprehension: minimum raw score = 9, maximum raw score = 45. A higher score represents better functioning.; Independence: minimum raw score = 8, maximum raw score = 40. A higher score represents better functioning.; Mobility: minimum raw score = 9, maximum raw score = 45. A higher score represents better functioning.; Satisfaction with Social Roles & Activities: minimum raw score = 10, maximum raw score = 50. A higher score represents better functioning.; Upper Extremity Function: minimum raw score = 9, maximum raw score = 45. A higher score represents better functioning.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Brief Symptom Inventory 18	Brief Symptom Inventory with 18 items contains three six-item scales for somatization, anxiety, depression, and the global Scale Global Severity Index (GSI). Each item is scored either 0 (Not at all), 1 (A little bit), 2 (Moderately), 3 (Quite a bit), 4 (Extremely), or R (Refused).; The GSI therefore ranges between 0 (minimum) - 72 (maximum) and the three scales range between 0 (minimum) - 24 (maximum).; Higher scores indicate worse outcome.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	NIH Toolbox - Pattern Comparison Processing Speed Test	An assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same.; Participants are measured based on reaction time (seconds) and accuracy.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	NIH Toolbox - Dimensional Change Card Sort Test	An assessment of cognitive flexibility and attention. Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape).; Participants are measured based on reaction time (seconds) and accuracy.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	NIH Toolbox - Picture Vocabulary Test	An assessment of receptive vocabulary administered in a computer-adaptive test (CAT) format. Participants must choose which of four pictures best represents a word presented via audio.; Participants are measured based on reaction time (seconds) and accuracy.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	NIH Toolbox - List Sorting Working Memory Test	Designed to assess working memory (WM). List Sorting is a sequencing task requiring participants to sort and sequence stimuli that are presented visually and auditorily.; Participants are measured based on accuracy.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	NIH Toolbox - Flanker Inhibitory Control and Attention Test	An assessment of inhibitory control and attention. The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it.; Participants are measured based on reaction time (seconds) and accuracy.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	NIH Toolbox - 9-hole Pegboard Dexterity Test	The NIH Toolbox 9-Hole Pegboard Dexterity Test is a simple test of manual dexterity; it records the time required for the participant to accurately place and remove nine plastic pegs into a plastic pegboard. Raw scores are recorded as time in seconds that it takes the participant to complete the task with each hand (a separate score for each - Dominant vs. Non-Dominant Hand).; Shorter time to complete the task indicates a better outcome. Longer time to complete the task indicates a worse outcome.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Rey Auditory Verbal Learning Test	Immediate learning and delayed recall of a word list	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Verbal Fluency	Attentional control and verbal generativity	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Wechsler Adult Intelligence Scale - IV: Processing Speed Index	Information processing rate on paper-pencil tasks requiring visual attention. It is composed of 10 core subtests and five supplemental subtests, with the 10 core subtests comprising the Full Scale IQ.; There are four index scores representing major components of intelligence: Verbal Comprehension Index (VCI); Perceptual Reasoning Index (PRI); Working Memory Index (WMI); Processing Speed Index (PSI); Two broad scores are also generated, which can be used to summarize general intellectual abilities: Full Scale IQ (FSIQ), based on the total combined performance of the VCI, PRI, WMI, and PSI; General Ability Index (GAI), based only on the six subtests that comprise the VCI and PRI; The range of possible WAIS-IV (Wechsler Adult Intelligence Scale - IV) full scale IQs is 45-155. The WAIS-IV computes scaled scores for each individual based exclusively on chronological age.; Higher score indicates better outcome.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Plasma cytokines	measure plasma cytokines via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Interleukin 1-alpha	measure IL-1a (Interleukin 1-alpha) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Interleukin 4	measure IL-4 (Interleukin 4) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Tumor necrosis factor alpha	measure TNFa (Tumor necrosis factor alpha) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Interleukin 6	measure IL-6 via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Interleukin 10	measure IL-10 (Interleukin 10) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Albumin	measure concentration of albumin via BCG (bromocresol green) immunochemical analysis	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion