A Phase 2 interventional study of Autologous HB-adMSCs and Normal Saline in Traumatic Brain Injury, sponsored by Hope Biosciences LLC. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Hope Biosciences LLC · Phase 2, Interventional, and Treatment
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.
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 at least 1 hour 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.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 51 is close to the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Hope Biosciences LLC is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Known history of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autologous Adipose Derived Mesenchymal Stem Cells
Biological: Autologous HB-adMSCs
Normal Saline
Drug: Normal Saline
Hope Biosciences autologous adipose-derived mesenchymal stem cells
Sterile Saline Solution 0.9%
Glucose
clinical lab evaluation of level of glucose in the blood (mg/dL)
Time frame: 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
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)
Time frame: 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
Albumin
clinical lab evaluation of level of albumin in the blood (g/dL)
Time frame: 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
Total Protein
clinical lab evaluation of total protein in the blood (g/dL)
Time frame: 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
Sodium
clinical lab evaluation of total sodium in the blood (mmol/L)
Time frame: 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
Total carbon dioxide
clinical lab evaluation of total carbon dioxide in the blood (mmol/L)
Time frame: 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
Potassium
clinical lab evaluation of potassium in the blood (mmol/L)
Time frame: 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
Chloride
clinical lab evaluation of chloride in the blood (mmol/L)
Time frame: 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
BUN (blood urea nitrogen)
clinical evaluation of blood urea nitrogen (BUN) (mg/dL)
Time frame: 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
Creatinine
clinical evaluation of creatinine in blood (mg/dL
Time frame: 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
Alkaline phosphatase
clinical evaluation of alkaline phosphatase (ALP) in blood (IU/L)
Time frame: 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
Alanine aminotransferase
clinical evaluation of alanine aminotransferase (ALT) in blood (IU/L)
Time frame: 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
Aspartate aminotransferase
clinical evaluation of aspartate aminotransferase (AST) in blood (IU/L)
Time frame: 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
Total Bilirubin
clinical evaluation of total bilirubin in blood (mg/dL)
Time frame: 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
White blood cell
clinical evaluation of white blood cells (WBC) in blood (x 10\^3/uL)
Time frame: 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
Red blood cell
clinical evaluation of red blood cells (RBC) in blood (x 10\^6/uL)
Time frame: 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
Hemoglobin
clinical evaluation of hemoglobin in blood (g/dL)
Time frame: 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
Hematocrit
clinical evaluation of hematocrit in blood (%)
Time frame: 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
Mean corpuscular volume
clinical evaluation of mean corpuscular volume (MCV) in blood (fL)
Time frame: 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
Mean corpuscular hemoglobin
clinical evaluation of mean corpuscular hemoglobin (MCH) in blood (pg)
Time frame: 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
Mean corpuscular hemoglobin concentration
clinical evaluation of mean corpuscular hemoglobin concentration (MCHC) in blood (g/dL)
Time frame: 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
Red cell distribution width
clinical evaluation of red cell distribution width (RDW) in blood (%)
Time frame: 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
Neutrophils
clinical evaluation of neutrophils in blood (%)
Time frame: 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
Lymphocytes
clinical evaluation of lymphocytes in blood (%)
Time frame: 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
Monocytes
clinical evaluation of monocytes in blood (%)
Time frame: 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
Eosinophils
clinical evaluation of eosinophils in blood (%)
Time frame: 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
Basophils
clinical evaluation of basophils in blood (%)
Time frame: 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
Absolute Neutrophils
clinical evaluation of absolute neutrophils in blood (x 10\^3/uL)
Time frame: 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
Absolute lymphocytes
clinical evaluation of absolute lymphocytes in blood (x 10\^3/uL)
Time frame: 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
Absolute monocytes
clinical evaluation of absolute monocytes in blood (x 10\^3/uL)
Time frame: 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
Absolute eosinophils
clinical evaluation of absolute eosinophils in blood (x 10\^3/uL)
Time frame: 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
Absolute basophils
clinical evaluation of absolute basophils in blood (x 10\^3/uL)
Time frame: 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
Immature Granulocytes
clinical evaluation of immature granulocytes in blood (%)
Time frame: 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
Absolute Immature Granulocytes
clinical evaluation of absolute immature granulocytes in blood (x 10\^3/uL)
Time frame: 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
Platelets
clinical evaluation of platelets in blood (x 10\^3/uL)
Time frame: 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
Prothrombin Time
clinical evaluation of time for blood to coagulate (seconds)
Time frame: 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
INR (international normalized ratio)
clinical evaluation of international normalized ratio of blood coagulation (no unit)
Time frame: 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
Urine Pregnancy (if applicable)
clinical evaluation of human chorionic gonadotropin (hCG) in urine (positive/negative)
Time frame: 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
Whole brain MRI (Magnetic resonance imaging)
DTI (Diffusion tensor imaging) to assess macro- and micro-structural properties
Time frame: Baseline, change from baseline at 6 months post-infusion
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
Time frame: Baseline, change from baseline at 6 months post-infusion
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.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Disability Rating Scale
Rating of level of arousal, cognitive ability related to activities of daily living, and level of functioning.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Behavior Rating of Executive Functions-Adult
Behavior Regulation and Metacognitive Indices assess everyday executive functions
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
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.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
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.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
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.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
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.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
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.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
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.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
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.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
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.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Rey Auditory Verbal Learning Test
Immediate learning and delayed recall of a word list
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Verbal Fluency
Attentional control and verbal generativity
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
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.
Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Plasma cytokines
measure plasma cytokines via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines
Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Interleukin 1-alpha
measure IL-1α (Interleukin 1-alpha) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines
Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Interleukin 4
measure IL-4 (Interleukin 4) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines
Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Tumor necrosis factor alpha
measure TNFα (Tumor necrosis factor alpha) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines
Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Interleukin 6
measure IL-6 via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines
Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Interleukin 10
measure IL-10 (Interleukin 10) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines
Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Albumin
measure concentration of albumin via BCG (bromocresol green) immunochemical analysis
Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
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