Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Marcus Foundation | OTHER |
| Emory University | OTHER |
| M.D. Anderson Cancer Center | OTHER |
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to determine the efficacy of a single intravenous infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or myeloablative medications prior to the infusion. Subjects will be followed for one year post infusion for safety and efficacy. Assessments will examine safety and tolerability of the infusion, change in neurological symptoms, change in quality of life, and emotional and cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and 365 days post infusion.
This is a multicenter, placebo controlled, randomized, double blinded Phase 2 study in 100 subjects 18-90 years of age who have sustained a recent ischemic stroke. Potential subjects can be screened and consented the day of their stroke (Day 1). Treatment with umbilical cord blood (UCB) cells or placebo will be administered intravenously as a single infusion as early as 3 days but no later than 10 days after the patient's stroke. UCB units will be selected from an accredited U.S. public cord bank based on blood type, race and a targeted cell dose ranging between 0.5 to 5 x 10^7 total nucleated cell count (TNCC)/kg. Study subjects will not receive immunosuppressive or myeloablative medications prior to infusion of the cord blood or placebo.
All subjects, families and medical staff will be blinded to treatment arm. When a subject is randomized to study drug at a clinical site without a cord blood bank, the selected cord blood units (CBU) will be shipped frozen overnight to the site. Once selected and available on site, each CBU will be thawed, washed, tested, released and infused intravenously using common standard operating procedures (SOPs) at all sites. For subjects randomized to placebo, a diluent with the same appearance and odor as a CBU will be prepared.
Patients will have baseline magnetic resonance imaging (MRI) and will be assessed at 1, 3, 6, and 12 months for functional outcomes. All patients will receive standard of care therapy while enrolled in this study and all subjects will be strongly encouraged to participate in rehabilitative therapy.
The primary objective of the study is to determine, in a randomized, placebo controlled trial, the efficacy of a single intravenous (IV) infusion of unrelated donor UCB for improving functional outcomes in patients with ischemic stroke. The secondary objectives are as follows:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Cord Blood | Experimental | A single intravenous infusion of umbilical cord blood within 3-10 days following stroke. |
|
| Placebo | Placebo Comparator | A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Blood | Biological | Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Shift in Modified Rankin Scale (mRS) | The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes. | baseline to 3 months post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Infusion Reactions | up to 1 year post infusion | |
| Number of Product-related Infections | up to 1 year post infusion | |
| Number of Alloimmunization Events |
Not provided
Inclusion Criteria:
18-90 years old
Recent, acute, cortical, hemispheric, ischemic stroke in the MCA (middle cerebral artery) distribution without a clinically significant midline shift as detected by MRI as a DWI (diffusion-weighted imaging) abnormality. If unable to obtain a MRI scan, patients may be included if there is clear evidence of ischemic cortical involvement in the MCA distribution demonstrated by computed tomography and a clinical exam consistent with cortical involvement.
NIHSS 6-15 (R) and 6-20 (L) at the time of informed consent. Subjects with a >4-point increase of NIHSS from time of consent (worsening of score) will not be eligible for infusion.
Subjects must have a platelet count >100,000/uL, hemoglobin >8gm/dL, absolute lymphocyte count (ALC) ≥ 1200 for African American patients and ≥1500 for all other racial-ethnic groups, and WBC (white blood cell) count >2,500/uL OR Historical pre-stroke value of ALC ≥ 1200 for African American and ≥1500 for all other racial-ethnic groups within 6 months of stroke
-And- a post stroke ALC value of ≥ 1000, platelet count >100,000/uL, hemoglobin >8gm/dL and WBC >2,500/uL.
Subjects who received tPA (Tissue plasminogen Activator) or underwent endovascular reperfusion may be included in the study
Able to provide consent to study or consent is obtained from the patient's legal representative
Subjects of childbearing potential must practice effective contraception during the study, and be willing to continue contraception for at least 6 months after intervention so that, in the opinion of the Investigator, they will not become pregnant during the course of the study
Is a good candidate for the trial, in the opinion of the Investigator
Agrees to participate in follow-up visits
ABO/Rh and race matched CBU(s) with a minimum of 0.5 x 10^7 TNCC/kg based on the pre-cryopreservation TNCC is available for infusion
Has not had a disease or therapy that would compromise current immune function.
Has a serum creatinine ≤2 mg/dL OR Glomerular Filtration Rate (GFR) ≥30mL/min
Exclusion Criteria:
An individual is ineligible to participate if any of the following apply:
Exclusionary Medical Conditions:
Prohibited Concomitant or Prior Therapies
Other Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joanne Kurtzberg, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| University of Florida Health Shands Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Umbilical Cord Blood | A single intravenous infusion of umbilical cord blood within 3-10 days following stroke. Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 total nucleated cell count (TNCC)/kg. |
| FG001 | Placebo | A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke. Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB (umbilical cord blood) unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Umbilical Cord Blood | A single intravenous infusion of umbilical cord blood within 3-10 days following stroke. Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Shift in Modified Rankin Scale (mRS) | The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes. | Modified Intention To Treat population (participants who have a baseline and 90 day mRS score) | Posted | Median | Inter-Quartile Range | score on a scale | baseline to 3 months post infusion |
|
Up to 1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Umbilical Cord Blood | A single intravenous infusion of umbilical cord blood within 3-10 days following stroke. Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEART FAILURE | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BRONCHIAL OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Poehlein, MB | Duke University | 919-668-8473 | emily.poehlein@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2018 | Jul 19, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001930 | Brain Injuries |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Other | The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm. |
|
| up to 1 year post infusion |
| Number of Graft vs. Host Disease Events | up to 1 year post infusion |
| Number of Study Related and Unexpected Adverse Events (AEs) | up to 1 year post infusion |
| Mortality | up to 1 year post infusion |
| Number of Participants With Functional Independence | Functional independence at 90 days defined as a 90-day mRS (modified Rankin Scale) score of 0, 1, or 2. The mRS has a range of 0 to 5, where lower scores indicate a better outcome. | 90 days post infusion |
| Shift in Modified Rankin Scale (mRS) From Baseline to 30 Days Post Infusion | The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes. | baseline to 30 days post infusion |
| Shift in Modified Rankin Scale (mRS) From Baseline to 180 Days Post Infusion | The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes. | baseline to 180 days post infusion |
| The National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days | The NIHSS has a range of 0 to 42, where higher scores indicate greater impairment. | 90 days post infusion |
| Barthel Index (BI) Score at 90 Days | The Barthel Index assesses functional independence, generally in stroke patients. The BI has a range of 0 to 100 with 0 indicating total dependency and 100 indicating complete independence. | 90 days post infusion |
| Stroke Impact Scale-16 (SIS-16) Score at 90 Days | The SIS-16 has a range of 0 to 100 with higher scores indicating a higher quality of life. | 90 days post infusion |
| The European Quality of Life (EQ-5D-3L) Visual Analogue Score (VAS) at 90 Days | The EQ-5D-3L VAS ranges from 0 to 100 with 0 being the worst possible health status and 100 being the best possible health status. | 90 days post infusion |
| Patient Health Questionnaire Scale (PHQ 8) Score at 90 Days | The PHQ 8 has a range of 0 to 24 with 0 indicating no depression and 24 indicating severe depression. | 90 days post infusion |
| Telephone Interview for Cognitive Status (TICS) Total Score at 30 Days Post Infusion | The TICS has a range of 0 to 41 with a higher score indicating better cognitive status. | 30 days post infusion |
| Telephone Interview for Cognitive Status (TICS) Total Score at 1 Year Post Infusion | The TICS has a range of 0 to 41 with a higher score indicating better cognitive status. | 1 year post infusion |
| Trail Making Test Score at 90 Days Post Infusion (Trail A) | Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Reported in seconds needed to complete Trail A. | 90 days post infusion |
| Trail Making Test Score at 90 Days Post Infusion (Trail B) | Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. Reported in seconds needed to complete Trail B. | 90 days post infusion |
| Montreal Cognitive Assessment (MoCA) Score at 90 Days Post Infusion | The MoCA has a range of 0 to 30 with lower scores indicating more severe cognitive impairment. | 90 days post infusion |
| Hopkins Verbal Learning Test-Revised (HVLT-R) Score at 90 Days Post Infusion | The HVLT-R is a sum of three trials involving word recall. It has a total range of 0 to 36 with higher scores indicating better recall and greater cognition. | 90 days post infusion |
| Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion | For all sub-components (Physical Functioning, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, and General Health), a higher score indicates better health. Scales are standardized to obtain a score ranging from 0 to 100 and a mean score of 50 has been articulated as a normative value for all scales. | 90 days post infusion |
| Controlled Oral Word Association Test (COWAT) Score at 90 Days Post Infusion | The COWAT is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Reported as the total number of words produced for F, A, and S. More words indicates better cognition. | 90 days post infusion |
| Oral Symbol Digit Modalities Test (SDMT) Score at 90 Days Post Infusion | The SDMT is a measure of processing speed wherein the participant is given 120 seconds to orally match symbols with digits as quickly as possible. Reported as the number of correct associations where a larger number indicates better cognition. | 90 days post infusion |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Emory University School of Medicine | Atlanta | Georgia | 30303 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Withdrawal by Subject |
|
| Death |
|
| BG001 | Placebo | A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke. Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo | A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke. Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm. |
|
|
|
| Secondary | Number of Infusion Reactions | Safety population | Posted | Number | reactions | up to 1 year post infusion |
|
|
|
| Secondary | Number of Product-related Infections | Safety population | Posted | Number | infections | up to 1 year post infusion |
|
|
|
| Secondary | Number of Alloimmunization Events | Posted | Number | events | up to 1 year post infusion |
|
|
|
| Secondary | Number of Graft vs. Host Disease Events | Safety population | Posted | Number | events | up to 1 year post infusion |
|
|
|
| Secondary | Number of Study Related and Unexpected Adverse Events (AEs) | Safety population | Posted | Number | events | up to 1 year post infusion |
|
|
|
| Secondary | Mortality | Safety population | Posted | Count of Participants | Participants | up to 1 year post infusion |
|
|
|
| Secondary | Number of Participants With Functional Independence | Functional independence at 90 days defined as a 90-day mRS (modified Rankin Scale) score of 0, 1, or 2. The mRS has a range of 0 to 5, where lower scores indicate a better outcome. | Modified Intention To Treat population. | Posted | Count of Participants | Participants | 90 days post infusion |
|
|
|
| Secondary | Shift in Modified Rankin Scale (mRS) From Baseline to 30 Days Post Infusion | The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes. | Modified Intention To Treat population with a 30 day mRS score available | Posted | Median | Inter-Quartile Range | shift in score | baseline to 30 days post infusion |
|
|
|
| Secondary | Shift in Modified Rankin Scale (mRS) From Baseline to 180 Days Post Infusion | The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes. | Modified Intention To Treat population with a 180 day mRS score available | Posted | Median | Inter-Quartile Range | shift in score | baseline to 180 days post infusion |
|
|
|
| Secondary | The National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days | The NIHSS has a range of 0 to 42, where higher scores indicate greater impairment. | Modified Intention To Treat population with NIHSS score available | Posted | Median | Inter-Quartile Range | score on a scale | 90 days post infusion |
|
|
|
| Secondary | Barthel Index (BI) Score at 90 Days | The Barthel Index assesses functional independence, generally in stroke patients. The BI has a range of 0 to 100 with 0 indicating total dependency and 100 indicating complete independence. | Modified Intention To Treat population with BI available at 90 days | Posted | Median | Inter-Quartile Range | score on a scale | 90 days post infusion |
|
|
|
| Secondary | Stroke Impact Scale-16 (SIS-16) Score at 90 Days | The SIS-16 has a range of 0 to 100 with higher scores indicating a higher quality of life. | Modified Intention to Treat population with SIS-16 score available at 90 days | Posted | Median | Inter-Quartile Range | score on a scale | 90 days post infusion |
|
|
|
| Secondary | The European Quality of Life (EQ-5D-3L) Visual Analogue Score (VAS) at 90 Days | The EQ-5D-3L VAS ranges from 0 to 100 with 0 being the worst possible health status and 100 being the best possible health status. | Modified Intention To Treat population with EQ-5D-3L VAS score available at 90 days | Posted | Median | Inter-Quartile Range | score on a scale | 90 days post infusion |
|
|
|
| Secondary | Patient Health Questionnaire Scale (PHQ 8) Score at 90 Days | The PHQ 8 has a range of 0 to 24 with 0 indicating no depression and 24 indicating severe depression. | Modified Intention To Treat population with PHQ 8 score available at 90 days | Posted | Median | Inter-Quartile Range | score on a scale | 90 days post infusion |
|
|
|
| Secondary | Telephone Interview for Cognitive Status (TICS) Total Score at 30 Days Post Infusion | The TICS has a range of 0 to 41 with a higher score indicating better cognitive status. | Modified Intent To Treat population with a TICS score at 30 days | Posted | Median | Inter-Quartile Range | score on a scale | 30 days post infusion |
|
|
|
| Secondary | Telephone Interview for Cognitive Status (TICS) Total Score at 1 Year Post Infusion | The TICS has a range of 0 to 41 with a higher score indicating better cognitive status. | Modified Intent To Treat population with a TICS score at 1 year | Posted | Median | Inter-Quartile Range | score on a scale | 1 year post infusion |
|
|
|
| Secondary | Trail Making Test Score at 90 Days Post Infusion (Trail A) | Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Reported in seconds needed to complete Trail A. | Modified Intent To Treat population with Trail A speed available | Posted | Median | Inter-Quartile Range | seconds | 90 days post infusion |
|
|
|
| Secondary | Trail Making Test Score at 90 Days Post Infusion (Trail B) | Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. Reported in seconds needed to complete Trail B. | Modified Intent To Treat population with Trail B speed available | Posted | Median | Inter-Quartile Range | seconds | 90 days post infusion |
|
|
|
| Secondary | Montreal Cognitive Assessment (MoCA) Score at 90 Days Post Infusion | The MoCA has a range of 0 to 30 with lower scores indicating more severe cognitive impairment. | Modified Intent To Treat population with MoCA score available at 90 days | Posted | Median | Inter-Quartile Range | score on a scale | 90 days post infusion |
|
|
|
| Secondary | Hopkins Verbal Learning Test-Revised (HVLT-R) Score at 90 Days Post Infusion | The HVLT-R is a sum of three trials involving word recall. It has a total range of 0 to 36 with higher scores indicating better recall and greater cognition. | Modified Intent To Treat population with HVLT-R scores available at 90 days | Posted | Median | Inter-Quartile Range | score on a scale | 90 days post infusion |
|
|
|
| Secondary | Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion | For all sub-components (Physical Functioning, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, and General Health), a higher score indicates better health. Scales are standardized to obtain a score ranging from 0 to 100 and a mean score of 50 has been articulated as a normative value for all scales. | Modified Intent To Treat population with SF-36 scores available at 90 days | Posted | Median | Inter-Quartile Range | score on a scale | 90 days post infusion |
|
|
|
| Secondary | Controlled Oral Word Association Test (COWAT) Score at 90 Days Post Infusion | The COWAT is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Reported as the total number of words produced for F, A, and S. More words indicates better cognition. | Modified Intent To Treat population with COWAT score available at 90 days | Posted | Median | Inter-Quartile Range | words | 90 days post infusion |
|
|
|
| Secondary | Oral Symbol Digit Modalities Test (SDMT) Score at 90 Days Post Infusion | The SDMT is a measure of processing speed wherein the participant is given 120 seconds to orally match symbols with digits as quickly as possible. Reported as the number of correct associations where a larger number indicates better cognition. | Modified Intent To Treat population with SDMT score available at 90 days | Posted | Median | Inter-Quartile Range | associations | 90 days post infusion |
|
|
|
| 4 |
| 52 |
| 14 |
| 52 |
| 36 |
| 52 |
| EG001 | Placebo | A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke. Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm. | 1 | 27 | 11 | 27 | 17 | 27 |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | Non-systematic Assessment |
|
| BRONCHIAL INFECTION | Infections and infestations | Non-systematic Assessment |
|
| BRONCHIAL OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| BULLOUS DERMATITIS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | Non-systematic Assessment |
|
| COGNITIVE DISTURBANCE | Nervous system disorders | Non-systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | Non-systematic Assessment |
|
| CONFUSION | Psychiatric disorders | Non-systematic Assessment |
|
| DEATH NOS | General disorders | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| ENDOCARDITIS INFECTIVE | Infections and infestations | Non-systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| FRACTURE | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | Non-systematic Assessment |
|
| HYPERTENSION | Vascular disorders | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | Non-systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| INTRACRANIAL HEMORRHAGE | Nervous system disorders | Non-systematic Assessment |
|
| ISCHEMIA CEREBROVASCULAR | Nervous system disorders | Non-systematic Assessment |
|
| LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | Cardiac disorders | Non-systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | Non-systematic Assessment |
|
| SEIZURE | Nervous system disorders | Non-systematic Assessment |
|
| SEPSIS | Infections and infestations | Non-systematic Assessment |
|
| SKIN INFECTION | Infections and infestations | Non-systematic Assessment |
|
| STROKE | Nervous system disorders | Non-systematic Assessment |
|
| THROMBOEMBOLIC EVENT | Vascular disorders | Non-systematic Assessment |
|
| MUSCLE WEAKNESS RIGHT-SIDED | Nervous system disorders | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | Non-systematic Assessment |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | Non-systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | Non-systematic Assessment |
|
| ANEMIA | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| ANXIETY | Psychiatric disorders | Non-systematic Assessment |
|
| APNEA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | Non-systematic Assessment |
|
| BACTEREMIA | Infections and infestations | Non-systematic Assessment |
|
| CARDIAC DISORDERS - OTHER, SPECIFY | Cardiac disorders | Non-systematic Assessment |
|
| CARDIAC TROPONIN T INCREASED | Investigations | Non-systematic Assessment |
|
| CHEST PAIN - CARDIAC | Cardiac disorders | Non-systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | Non-systematic Assessment |
|
| COGNITIVE DISTURBANCE | Nervous system disorders | Non-systematic Assessment |
|
| CONCENTRATION IMPAIRMENT | Nervous system disorders | Non-systematic Assessment |
|
| CONGENITAL, FAMILIAL AND GENETIC DISORDERS - OTHER | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| DELAYED ORGASM | Psychiatric disorders | Non-systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | Non-systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | Non-systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| DIZZINESS | Nervous system disorders | Non-systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | Non-systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | Non-systematic Assessment |
|
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | Non-systematic Assessment |
|
| EDEMA LIMBS | General disorders | Non-systematic Assessment |
|
| ENDOCRINE DISORDERS - OTHER, SPECIFY | Endocrine disorders | Non-systematic Assessment |
|
| ESOPHAGITIS | Gastrointestinal disorders | Non-systematic Assessment |
|
| EYE PAIN | Eye disorders | Non-systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| FATIGUE | General disorders | Non-systematic Assessment |
|
| FEVER | General disorders | Non-systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | Non-systematic Assessment |
|
| GASTRIC ULCER | Gastrointestinal disorders | Non-systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | Non-systematic Assessment |
|
| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | Gastrointestinal disorders | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | Non-systematic Assessment |
|
| HEART FAILURE | Cardiac disorders | Non-systematic Assessment |
|
| HEMATURIA | Renal and urinary disorders | Non-systematic Assessment |
|
| HEPATITIS B REACTIVATION | Infections and infestations | Non-systematic Assessment |
|
| HYPERGLYCEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPERKALEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPERNATREMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPERTENSION | Vascular disorders | Non-systematic Assessment |
|
| HYPERURICEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPOCALCEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPOKALEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPONATREMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | Non-systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | Non-systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | Non-systematic Assessment |
|
| INTRACRANIAL HEMORRHAGE | Nervous system disorders | Non-systematic Assessment |
|
| INVESTIGATIONS - OTHER, SPECIFY | Investigations | Non-systematic Assessment |
|
| ISCHEMIA CEREBROVASCULAR | Nervous system disorders | Non-systematic Assessment |
|
| LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | Cardiac disorders | Non-systematic Assessment |
|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | Non-systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | Non-systematic Assessment |
|
| METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIF | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| MUCOSITIS ORAL | Gastrointestinal disorders | Non-systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| OBSTRUCTION GASTRIC | Gastrointestinal disorders | Non-systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| PAIN OF SKIN | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | Non-systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | Non-systematic Assessment |
|
| PERSONALITY CHANGE | Psychiatric disorders | Non-systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | Non-systematic Assessment |
|
| PROSTATIC OBSTRUCTION | Reproductive system and breast disorders | Non-systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| PULMONARY EDEMA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, | Reproductive system and breast disorders | Non-systematic Assessment |
|
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| SEIZURE | Nervous system disorders | Non-systematic Assessment |
|
| SINUS BRADYCARDIA | Cardiac disorders | Non-systematic Assessment |
|
| SINUS TACHYCARDIA | Cardiac disorders | Non-systematic Assessment |
|
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SP | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SKIN ULCERATION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SPASTICITY | Nervous system disorders | Non-systematic Assessment |
|
| THROMBOEMBOLIC EVENT | Vascular disorders | Non-systematic Assessment |
|
| URINARY INCONTINENCE | Renal and urinary disorders | Non-systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | Non-systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | Non-systematic Assessment |
|
| URINE OUTPUT DECREASED | Investigations | Non-systematic Assessment |
|
| VAGINAL INFECTION | Infections and infestations | Non-systematic Assessment |
|
| VENTRICULAR ARRHYTHMIA | Cardiac disorders | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Non-systematic Assessment |
|
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| PAIN | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Role Limitations Due to Physical Health |
|
|
| Role Limitations Due to Emotional Problems |
|
|
| Energy/Fatigue |
|
|
| Emotional Well-being |
|
|
| Social Functioning |
|
|
| Pain |
|
|
| General Health |
|
|