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A multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at multiple investigational study sites.
An open-label study with a single treatment arm involving 20 participants with progressive MS at multiple investigational study sites. After providing informed consent, participants meeting the inclusion and exclusion criteria will be randomized and approximately 4 weeks later will undergo a bone-marrow aspiration (BMA). Each participants will receive three Intrathecal cell transplantations within 16 weeks and will be followed for 12 weeks for safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NurOwn (MSC-NTF cells) | Experimental | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NurOwn (MSC-NTF cells) | Biological | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study. Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment. | Up to 28 weeks post-first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT). The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Cohen, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Stanford University School of Medicine |
Not meeting inclusion exclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | NurOwn (MSC-NTF Cells) | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors NurOwn (MSC-NTF cells). Study drug was supplied in one 5 mL syringe containing 4 mL of NurOwn (MSC-NTF cells) suspension at a dose of 100-125 x106 cells for IT administration. 3 doses of NurOwn (MSC-NTF cells) were transplanted intrathecally at 8-week intervals (Day 0-1, week 8, and week 16) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2019 | Sep 11, 2022 |
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Open label
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| From Baseline (pre-first treatment) to 28 weeks post-first treatment |
| Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
| Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses. The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
| Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 | Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
| Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks. It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
| Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels. The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
| Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
| Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment | Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome | From Baseline (pre-first treatment) to 16 weeks post first treatment |
| Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment | Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome | From Baseline (pre-first treatment) to 16 weeks post first treatment |
| Redwood City |
| California |
| 94305 |
| United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics are for participants with a clinical diagnosis of primary or secondary progressive MS (PPMS or SPMS) based on the 2017 revised McDonald Criteria and confirmation by the Investigator that the disease has entered the progressive stage at least 6 months prior to enrollment
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| ID | Title | Description |
|---|---|---|
| BG000 | NurOwn (MSC-NTF Cells) | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Timed 25-foot walk speed | The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes | Mean | Standard Deviation | Feet/seconds |
| ||||||||||||||||
| Nine-Hole Peg Test (9HPT) | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses The participant is seated at a table with a container holding nine pegs and a block with 9 empty holes. On a start command, the participant picks up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. Higher values represent a worse outcome. | Mean | Standard Deviation | Seconds |
|
| 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 | Number of Participants With Treatment-emergent Adverse Events | Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study. Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment. | The primary, secondary, and exploratory efficacy endpoints were analyzed using the modified intent to treat (mITT) and Efficacy Evaluable (EE) populations The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Posted | Count of Participants | Participants | Up to 28 weeks post-first treatment |
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| ||||||||||||||||||||||||||
| Secondary | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT). The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. | The modified intent to treat (mITT) population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Posted | Count of Participants | Participants | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
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| Secondary | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes | mITT population | Posted | Count of Participants | Participants | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
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| |||||||||||||||||||||||||||
| Secondary | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses. The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. | Posted | Count of Participants | Participants | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
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| Secondary | Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 | Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. The participants in mITT population whose EDSS Score was >5.5 at Baseline was analyzed. | Posted | Count of Participants | Participants | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
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| Secondary | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks. It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Posted | Count of Participants | Participants | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
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| Secondary | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels. The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Posted | Count of Participants | Participants | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
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| Secondary | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. | Posted | Count of Participants | Participants | From Baseline (pre-first treatment) to 28 weeks post-first treatment |
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| Secondary | Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment | Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome | mITT Population with data available at week 16 | Posted | Geometric Mean | Inter-Quartile Range | Picograms per milliliter | From Baseline (pre-first treatment) to 16 weeks post first treatment |
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| Secondary | Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment | Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome | mITT population with data available at week 16 | Posted | Geometric Mean | Inter-Quartile Range | picograms per milliliter | From Baseline (pre-first treatment) to 16 weeks post first treatment |
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28 weeks
Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NurOwn (MSC-NTF Cells) | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors | 0 | 18 | 2 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arachnoiditis | Nervous system disorders | Systematic Assessment | [1] Two participants experienced an SAE of arachnoiditis in one of three treatments (one participant with Grade 1 and one participant with Grade 3) that were considered probably related to the IT injection procedure and/or study treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Brainstorm Cell therapeutics | 201-488-0460 | Clinical.Trial@brainstorm-cell.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2019 | Sep 11, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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