Trial Outcomes & Findings for Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS (NCT NCT03799718)
NCT ID: NCT03799718
Last Updated: 2023-12-04
Results Overview
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.
COMPLETED
PHASE2
23 participants
Up to 28 weeks post-first treatment
2023-12-04
Participant Flow
Not meeting inclusion exclusion criteria
Unit of analysis: Treatments
Participant milestones
| Measure |
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)
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Overall Study
STARTED
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20 54
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Overall Study
COMPLETED
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18 53
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Overall Study
NOT COMPLETED
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2 1
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Reasons for withdrawal
| Measure |
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)
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Overall Study
Adverse Event
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2
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Baseline Characteristics
Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS
Baseline characteristics by cohort
| Measure |
NurOwn (MSC-NTF Cells)
n=18 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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|---|---|
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Age, Continuous
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47.4 years
STANDARD_DEVIATION 9.6 • n=113 Participants
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Sex: Female, Male
Female
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10 Participants
n=113 Participants
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Sex: Female, Male
Male
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8 Participants
n=113 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=113 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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18 Participants
n=113 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=113 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=113 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=113 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=113 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=113 Participants
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Race (NIH/OMB)
White
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15 Participants
n=113 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=113 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=113 Participants
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Region of Enrollment
United States
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18 Participants
n=113 Participants
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Timed 25-foot walk speed
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2.4 Feet/seconds
STANDARD_DEVIATION 1.6 • n=113 Participants
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Nine-Hole Peg Test (9HPT)
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35.2 Seconds
STANDARD_DEVIATION 15.7 • n=113 Participants
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PRIMARY outcome
Timeframe: Up to 28 weeks post-first treatmentPopulation: 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
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.
Outcome measures
| Measure |
NurOwn (MSC-NTF Cells)
n=18 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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Number of Participants With Treatment-emergent Adverse Events
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18 Participants
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SECONDARY outcome
Timeframe: From Baseline (pre-first treatment) to 28 weeks post-first treatmentPopulation: 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
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.
Outcome measures
| Measure |
NurOwn (MSC-NTF Cells)
n=18 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT)
Number of Participants with 25% or greater improvement from Baseline inT25FW speed or 9-HPT
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3 Participants
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Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT)
Number of Participants with <25% improvement from Baseline inT25FW speed or 9-HPT
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13 Participants
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Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT)
Number of Participants with missing data at week 28
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2 Participants
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SECONDARY outcome
Timeframe: From Baseline (pre-first treatment) to 28 weeks post-first treatmentPopulation: mITT population
≥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
Outcome measures
| Measure |
NurOwn (MSC-NTF Cells)
n=18 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed
Number of participants with missing values at week 28
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4 Participants
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Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed
Number of participants with 25% or more improvement
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2 Participants
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Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed
Number of participants without 25% or more improvement
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12 Participants
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SECONDARY outcome
Timeframe: From Baseline (pre-first treatment) to 28 weeks post-first treatmentPopulation: 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 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.
Outcome measures
| Measure |
NurOwn (MSC-NTF Cells)
n=18 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT
Number of Participants with 25% or greater improvement from Baseline to Week 28 in 9-HPT
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2 Participants
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Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT
Number of Participants with less than 25% improvement from Baseline to Week 28 in 9-HPT
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13 Participants
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Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT
Number of participants with missing values at week 28
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3 Participants
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SECONDARY outcome
Timeframe: From Baseline (pre-first treatment) to 28 weeks post-first treatmentPopulation: 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.
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.
Outcome measures
| Measure |
NurOwn (MSC-NTF Cells)
n=10 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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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
No of Participants with >5.5 in EDSS at Baseline with ≥0.5 Points Improvement from Baseline to Wk 28
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3 Participants
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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
No of Participants with >5.5 in EDSS at Baseline with <0.5 Points Improvement from Baseline to Wk 28
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7 Participants
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SECONDARY outcome
Timeframe: From Baseline (pre-first treatment) to 28 weeks post-first treatmentPopulation: 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 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.
Outcome measures
| Measure |
NurOwn (MSC-NTF Cells)
n=18 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12)
Number of Participants with ≥10 Points Improvement from Baseline to Week 28 in MSWS-12
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6 Participants
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Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12)
Number of Participants with <10 Points Improvement from Baseline to Week 28 in MSWS-12
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10 Participants
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Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12)
Number of Participants with missing data at week 28
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2 Participants
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SECONDARY outcome
Timeframe: From Baseline (pre-first treatment) to 28 weeks post-first treatmentPopulation: 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 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.
Outcome measures
| Measure |
NurOwn (MSC-NTF Cells)
n=18 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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|---|---|
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Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level
No. of participants with ≥8 Letter improvement at Week 28 in LCLA Binocular 2.5% Contrast Level
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4 Participants
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Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level
No. of Participants with <8 Letter Improvement at week 28 in LCLA Binocular 2.5% Contrast Level
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11 Participants
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Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level
Number of Participants with missing data at week 28
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3 Participants
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SECONDARY outcome
Timeframe: From Baseline (pre-first treatment) to 28 weeks post-first treatmentPopulation: 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.
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.
Outcome measures
| Measure |
NurOwn (MSC-NTF Cells)
n=18 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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|---|---|
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Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score
Number of Participants with ≥ 3 points Improvement from Baseline to Week 28 in SDMT Score
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10 Participants
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Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score
Number of Participants with < 3 points Improvement from Baseline to Week 28 in SDMT Score
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5 Participants
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Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score
Number of Participants with missing data at week 28
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3 Participants
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SECONDARY outcome
Timeframe: From Baseline (pre-first treatment) to 16 weeks post first treatmentPopulation: mITT Population with data available at week 16
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
Outcome measures
| Measure |
NurOwn (MSC-NTF Cells)
n=17 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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|---|---|
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Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment
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90.17 Picograms per milliliter
Interval -9.16 to 124.8
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SECONDARY outcome
Timeframe: From Baseline (pre-first treatment) to 16 weeks post first treatmentPopulation: mITT population with data available at week 16
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
Outcome measures
| Measure |
NurOwn (MSC-NTF Cells)
n=17 Participants
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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|---|---|
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Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment
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15.16 picograms per milliliter
Interval 0.2 to 19.44
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Adverse Events
NurOwn (MSC-NTF Cells)
Serious adverse events
| Measure |
NurOwn (MSC-NTF Cells)
n=18 participants at risk
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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|---|---|
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Nervous system disorders
Arachnoiditis
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11.1%
2/18 • Number of events 2 • 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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Other adverse events
| Measure |
NurOwn (MSC-NTF Cells)
n=18 participants at risk
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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|---|---|
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Nervous system disorders
Headache
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88.9%
16/18 • Number of events 35 • 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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Musculoskeletal and connective tissue disorders
Back pain
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83.3%
15/18 • Number of events 29 • 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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Infections and infestations
Urinary tract infection
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33.3%
6/18 • Number of events 8 • 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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Musculoskeletal and connective tissue disorders
Musculoskeletal pain
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27.8%
5/18 • Number of events 5 • 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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General disorders
Injection site pain
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22.2%
4/18 • Number of events 4 • 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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General disorders
Pyrexia
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22.2%
4/18 • Number of events 5 • 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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Musculoskeletal and connective tissue disorders
Arthralgia
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16.7%
3/18 • Number of events 3 • 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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Injury, poisoning and procedural complications
Fall
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16.7%
3/18 • Number of events 4 • 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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General disorders
Fatigue
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16.7%
3/18 • Number of events 3 • 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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Musculoskeletal and connective tissue disorders
Muscular weakness
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16.7%
3/18 • Number of events 4 • 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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Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
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16.7%
3/18 • Number of events 3 • 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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Musculoskeletal and connective tissue disorders
Pain in extremity
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16.7%
3/18 • Number of events 4 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60