Trial Outcomes & Findings for Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis (NCT NCT03355365)

NCT ID: NCT03355365

Last Updated: 2025-06-11

Results Overview

Changes in disability assessed based on composite score of EDSS, timed 25-foot walk (T25FW), and nine hole peg test (9HPT) (EDSS-Plus). Improvement is defined by at least one of the following three measures: ≥0.5 decrease in EDSS (if EDSS at entry is ≥ 6.0) or ≥ 1.0 decrease in EDSS (if EDSS at entry is ≤5.5), ≥20% increase in T25FW, or ≥20% increase in 9HPT in either dominant or non-dominant hand. Assessments were made at baseline and month 13. The number of patients who improved in any of the 3 composite measures in month 13 compared to baseline is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: Baseline and 13 months
• Results posted on: 2025-06-11

Participant Flow

Participant milestones

Measure	Treatment First, Then Placebo Participants will receive six autologous stem cell injections through spinal taps every 2 months over a year. After a period of 3 months, participants will crossover into the placebo group and receive six intrathecal injections of saline every 2 months over a year.	Placebo First, Then Treatment Participants will receive six placebo injections through spinal taps every 2 months over a year. After a period of 3 months, participants will crossover into the treatment group and receive six autologous stem cell injections every 2 months over a year.
Year 1, First Intervention STARTED	27	27
Year 1, First Intervention COMPLETED	24	27
Year 1, First Intervention NOT COMPLETED	3	0
Year 2, Crossover Intervention STARTED	24	27
Year 2, Crossover Intervention COMPLETED	22	25
Year 2, Crossover Intervention NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Treatment First, Then Placebo Participants will receive six autologous stem cell injections through spinal taps every 2 months over a year. After a period of 3 months, participants will crossover into the placebo group and receive six intrathecal injections of saline every 2 months over a year.	Placebo First, Then Treatment Participants will receive six placebo injections through spinal taps every 2 months over a year. After a period of 3 months, participants will crossover into the treatment group and receive six autologous stem cell injections every 2 months over a year.
Year 1, First Intervention Withdrawal by Subject	1	0
Year 1, First Intervention Protocol Violation	1	0
Year 1, First Intervention pandemic travel limitation	1	0
Year 2, Crossover Intervention pandemic travel limitation	1	0
Year 2, Crossover Intervention Adverse event as a result of long-COVID	1	0
Year 2, Crossover Intervention severe COVID	0	1
Year 2, Crossover Intervention failure to isolate MSCs from bone marrow	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Treatment First, Then Placebo n=27 Participants Participants will receive six intrathecal injections of autologous stem cells every 2 months over a year. After a 3 month pause, participants will crossover into the placebo group and receive six intrathecal injections of saline every 2 months over a year.	Placebo First, Then Treatment n=27 Participants Participants will receive six intrathecal injections of saline every 2 months over a year. After a 3 month pause, participants will crossover into the treatment group and receive six intrathecal injections of autologous stem cells every 2 months over a year.	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=27 Participants	0 Participants n=27 Participants	0 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=27 Participants	26 Participants n=27 Participants	53 Participants n=54 Participants
Age, Categorical >=65 years	0 Participants n=27 Participants	1 Participants n=27 Participants	1 Participants n=54 Participants
Age, Continuous	51 years STANDARD_DEVIATION 7 • n=27 Participants	49 years STANDARD_DEVIATION 9 • n=27 Participants	50 years STANDARD_DEVIATION 8 • n=54 Participants
Sex: Female, Male Female	18 Participants n=27 Participants	20 Participants n=27 Participants	38 Participants n=54 Participants
Sex: Female, Male Male	9 Participants n=27 Participants	7 Participants n=27 Participants	16 Participants n=54 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Baseline EDSS (expanded disability status scale) EDSS 3.0-5.5	14 Participants n=27 Participants	14 Participants n=27 Participants	28 Participants n=54 Participants
Baseline EDSS (expanded disability status scale) EDSS 6.0-6.5	13 Participants n=27 Participants	13 Participants n=27 Participants	26 Participants n=54 Participants

PRIMARY outcome

Timeframe: Baseline and 13 months

Population: There is no washout period after stem cell injections, therefore outcome measures in participants receiving placebo second in the sequence (treatment first, then placebo) may reflect sustained effects of stem cell treatment.

Changes in disability assessed based on composite score of EDSS, timed 25-foot walk (T25FW), and nine hole peg test (9HPT) (EDSS-Plus). Improvement is defined by at least one of the following three measures: ≥0.5 decrease in EDSS (if EDSS at entry is ≥ 6.0) or ≥ 1.0 decrease in EDSS (if EDSS at entry is ≤5.5), ≥20% increase in T25FW, or ≥20% increase in 9HPT in either dominant or non-dominant hand. Assessments were made at baseline and month 13. The number of patients who improved in any of the 3 composite measures in month 13 compared to baseline is reported.

Outcome measures

Measure	Treatment (IT MSC-NP) n=49 Participants Participants received six intrathecal injections of autologous stem cells every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants were treated either first in the sequence (treatment first, then placebo) or second in the sequence (placebo first, then treatment).	Placebo (IT Saline) n=49 Participants Participants received six intrathecal injections of saline every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants received placebo either first in the sequence (placebo first, then treatment) or second in the sequence (treatment first, then placebo).
Expanded Disability Status Scale (EDSS) Plus	17 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline and 13 months

Population: There is no washout period after stem cell injections, therefore outcome measures in participants receiving placebo second in the sequence (treatment first, then placebo) may reflect sustained effects of stem cell treatment.

The Multiple Sclerosis Functional Composite (MSFC) is a standardized tool used to quantify disability in people with multiple sclerosis (MS) by measuring leg function/ambulation (timed 25 foot walk), arm/hand function (9-hole peg test), and cognitive function (Paced Auditory Serial Addition Test). Each assessment is converted into a Z score. A Z-score of 0 represents the population mean. The composite MSFC Z-score represents an average of the 3 Z-scores. A positive change in composite Z-score in month 13 compared to baseline represents better performance and a negative change in composite Z score indicates worse performance.

Outcome measures

Measure	Treatment (IT MSC-NP) n=49 Participants Participants received six intrathecal injections of autologous stem cells every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants were treated either first in the sequence (treatment first, then placebo) or second in the sequence (placebo first, then treatment).	Placebo (IT Saline) n=49 Participants Participants received six intrathecal injections of saline every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants received placebo either first in the sequence (placebo first, then treatment) or second in the sequence (treatment first, then placebo).
Change in Multiple Sclerosis Functional Composite (MSFC) Z-Score From Baseline	-.13 change in composite z score Standard Deviation 0.85	-.06 change in composite z score Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline and 13 months

Population: There is no washout period after stem cell injections, therefore outcome measures in participants receiving placebo second in the sequence (treatment first, then placebo) may reflect sustained effects of stem cell treatment.

The Expanded Disability Status Scale (EDSS) is a standardized measure used to assess and track the level of disability in people with multiple sclerosis (MS), ranging from 0 (normal neurological status) to 10 (death due to MS) in 0.5 increments. Only ambulatory subjects were enrolled in this study with an EDSS between 3.0 and 6.5. Subgroups of participants were analyzed based on the degree of walking disability. EDSS 3.0-5.5 represents moderate to severe disability but able to walk without assistance, and EDSS 6.0-6.5 represents a need for unilateral or bilateral assistance to ambulate. A decrease in EDSS at month 13 compared to baseline is considered improvement.

Outcome measures

Measure	Treatment (IT MSC-NP) n=49 Participants Participants received six intrathecal injections of autologous stem cells every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants were treated either first in the sequence (treatment first, then placebo) or second in the sequence (placebo first, then treatment).	Placebo (IT Saline) n=49 Participants Participants received six intrathecal injections of saline every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants received placebo either first in the sequence (placebo first, then treatment) or second in the sequence (treatment first, then placebo).
Change in EDSS From Baseline	-0.12 change in score on a scale Standard Deviation 0.67	-0.15 change in score on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline and 13 months

Population: There is no washout period after stem cell injections, therefore outcome measures in participants receiving placebo second in the sequence (treatment first, then placebo) may reflect sustained effects of stem cell treatment.

The timed 25-foot walk (T25FW) is a test used in multiple sclerosis (MS) to assess a person's mobility and leg function, where individuals walk 25 feet as quickly and safely as possible, and the time taken is recorded. A positive percentage change indicates improved walking in month 13 compared to baseline, whereas a negative percentage change indicates worsening.

Outcome measures

Measure	Treatment (IT MSC-NP) n=49 Participants Participants received six intrathecal injections of autologous stem cells every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants were treated either first in the sequence (treatment first, then placebo) or second in the sequence (placebo first, then treatment).	Placebo (IT Saline) n=49 Participants Participants received six intrathecal injections of saline every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants received placebo either first in the sequence (placebo first, then treatment) or second in the sequence (treatment first, then placebo).
Percent Change in T25FW (Timed 25 Foot Walk) From Baseline	-14.4 % change Standard Deviation 41.1	-19.8 % change Standard Deviation 49.2

SECONDARY outcome

Timeframe: Baseline and 13 months

Population: There is no washout period after stem cell injections, therefore outcome measures in participants receiving placebo second in the sequence (treatment first, then placebo) may reflect sustained effects of stem cell treatment.

The 6-minute walk test (6MWT) in multiple sclerosis (MS) measures functional walking capacity by assessing the distance a person can walk in 6 minutes. A positive percentage change indicates improved walking capacity at month 13 compared to baseline, whereas a negative percentage change indicates worsening.

Outcome measures

Measure	Treatment (IT MSC-NP) n=49 Participants Participants received six intrathecal injections of autologous stem cells every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants were treated either first in the sequence (treatment first, then placebo) or second in the sequence (placebo first, then treatment).	Placebo (IT Saline) n=49 Participants Participants received six intrathecal injections of saline every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants received placebo either first in the sequence (placebo first, then treatment) or second in the sequence (treatment first, then placebo).
Percent Change in 6MWT (6 Minute Walk Test) From Baseline	-15.9 % change Standard Deviation 33.9	-13.5 % change Standard Deviation 29.7

SECONDARY outcome

Timeframe: Baseline and 13 months

Population: There is no washout period after stem cell injections, therefore outcome measures in participants receiving placebo second in the sequence (treatment first, then placebo) may reflect sustained effects of stem cell treatment.

The Nine-Hole Peg Test (9HPT) is a standardized, quantitative assessment used to measure manual dexterity and upper extremity function in individuals with multiple sclerosis (MS). Each hand, dominant (D) and non-dominant (ND) is assessed seperately. A positive percentage change indicates improved function at month 13 compared to baseline, whereas a negative percentage change indicates worsening.

Outcome measures

Measure	Treatment (IT MSC-NP) n=49 Participants Participants received six intrathecal injections of autologous stem cells every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants were treated either first in the sequence (treatment first, then placebo) or second in the sequence (placebo first, then treatment).	Placebo (IT Saline) n=49 Participants Participants received six intrathecal injections of saline every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants received placebo either first in the sequence (placebo first, then treatment) or second in the sequence (treatment first, then placebo).
Percent Change in 9HPT-D (9 Hole Peg Test in Dominant Hand) From Baseline	-2.1 % change Standard Deviation 18.1	-2.9 % change Standard Deviation 17.9

SECONDARY outcome

Timeframe: Baseline and 13 months

Population: There is no washout period after stem cell injections, therefore outcome measures in participants receiving placebo second in the sequence (treatment first, then placebo) may reflect sustained effects of stem cell treatment.

The Nine-Hole Peg Test (9HPT) is a standardized, quantitative assessment used to measure manual dexterity and upper extremity function in individuals with multiple sclerosis (MS). Each hand, dominant (D) and non-dominant (ND) is assessed seperately. A positive percentage change indicates improved function at month 13 compared to baseline, whereas a negative percentage change indicates worsening.

Outcome measures

Measure	Treatment (IT MSC-NP) n=49 Participants Participants received six intrathecal injections of autologous stem cells every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants were treated either first in the sequence (treatment first, then placebo) or second in the sequence (placebo first, then treatment).	Placebo (IT Saline) n=49 Participants Participants received six intrathecal injections of saline every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants received placebo either first in the sequence (placebo first, then treatment) or second in the sequence (treatment first, then placebo).
Percent Change in 9HPT-ND (9 Hole Peg Test in Non-Dominant Hand) From Baseline	-4.4 % change Standard Deviation 30.0	-4.1 % change Standard Deviation 15.0

SECONDARY outcome

Timeframe: Baseline and 13 months

Population: There is no washout period after stem cell injections, therefore outcome measures in participants receiving placebo second in the sequence (treatment first, then placebo) may reflect sustained effects of stem cell treatment.

The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a patient-reported outcome measure that assesses the impact of multiple sclerosis (MS) on walking ability. The self-administered questionnaire consists of 12 items addressing how MS has affected various aspects of walking over the past two weeks. Each of the 12 items is scored from 1 to 5 from: 1 = Not at all to 5 = Extremely. Raw total score ranges from 12 (no impairment) to 60 (maximum impairment). Raw score is converted to a standardized score (0-100 scale) producing a final score from 0 = No impact of MS on walking to 100 = Maximum impact. The change in score from baseline to post-intervention was calculated. A decrease in score at month 13 compared to baseline was considered improvement.

Outcome measures

Measure	Treatment (IT MSC-NP) n=49 Participants Participants received six intrathecal injections of autologous stem cells every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants were treated either first in the sequence (treatment first, then placebo) or second in the sequence (placebo first, then treatment).	Placebo (IT Saline) n=49 Participants Participants received six intrathecal injections of saline every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants received placebo either first in the sequence (placebo first, then treatment) or second in the sequence (treatment first, then placebo).
Change in MSWS-12 (12 Item MS Walking Scale) Score From Baseline	-.15 change in score Standard Deviation 12.2	-.15 change in score Standard Deviation 15.1

SECONDARY outcome

Timeframe: Baseline and 13 months

Population: There is no washout period after stem cell injections, therefore outcome measures in participants receiving placebo second in the sequence (treatment first, then placebo) may reflect sustained effects of stem cell treatment.

The Paced Auditory Serial Addition Test (PASAT) is a neuropsychological test used to assess cognitive impairments, attention, information processing speed, and working memory. The test involves listening to a series of single-digit numbers and the individual must add each new number to the one immediately before it. The score is the number of correct responses out of 60 items. The change in score from baseline to post-intervention is calculated. A positive change in score means an increase in the number of correct answers at month 13 compared to baseline, generally indicating improvement in information processing speed and sustained attention.

Outcome measures

Measure	Treatment (IT MSC-NP) n=49 Participants Participants received six intrathecal injections of autologous stem cells every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants were treated either first in the sequence (treatment first, then placebo) or second in the sequence (placebo first, then treatment).	Placebo (IT Saline) n=49 Participants Participants received six intrathecal injections of saline every 2 months over a year. Assessments were made 3 months after the last injection and compared to baseline. As part of the crossover study, participants received placebo either first in the sequence (placebo first, then treatment) or second in the sequence (treatment first, then placebo).
Change in PASAT (Paced Auditory Serial Addition Test) Score From Baseline	2.3 change in score Standard Deviation 5.5	1.4 change in score Standard Deviation 8.2

Adverse Events

Intrathecal MSC-NP Injection (Year 1)

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Intrathecal Saline Injection (Year 1)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Intrathecal MSC-NP Injection (Year 2)

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Intrathecal Saline Injection (Year 2)

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intrathecal MSC-NP Injection (Year 1) n=27 participants at risk Patients will receive six autologous stem cell injections through spinal taps every 2 months in year 1.	Intrathecal Saline Injection (Year 1) n=27 participants at risk Patients will receive six placebo injections through spinal taps every 2 months in year 1. Intrathecal saline injection: Placebo	Intrathecal MSC-NP Injection (Year 2) n=27 participants at risk Compassionate crossover design with subjects who were treated with saline/placebo in year 1 received MSC-NP injections in year 2.	Intrathecal Saline Injection (Year 2) n=24 participants at risk Compassionate crossover design with subjects who were treated with MSC-NP in year 1 received saline injections in year 2.
Infections and infestations infection	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Endocrine disorders hyperparathyroid	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Nervous system disorders Muscle weakness	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Blood and lymphatic system disorders pulmonary embolism	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	4.2% 1/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Infections and infestations COVID-19	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	4.2% 1/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Infections and infestations Cholecystitis	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	4.2% 1/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.

Other adverse events

Measure	Intrathecal MSC-NP Injection (Year 1) n=27 participants at risk Patients will receive six autologous stem cell injections through spinal taps every 2 months in year 1.	Intrathecal Saline Injection (Year 1) n=27 participants at risk Patients will receive six placebo injections through spinal taps every 2 months in year 1. Intrathecal saline injection: Placebo	Intrathecal MSC-NP Injection (Year 2) n=27 participants at risk Compassionate crossover design with subjects who were treated with saline/placebo in year 1 received MSC-NP injections in year 2.	Intrathecal Saline Injection (Year 2) n=24 participants at risk Compassionate crossover design with subjects who were treated with MSC-NP in year 1 received saline injections in year 2.
Infections and infestations Urinary tract infection	14.8% 4/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	11.1% 3/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	11.1% 3/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	8.3% 2/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Infections and infestations upper respiratory infection	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	7.4% 2/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	22.2% 6/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	20.8% 5/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Musculoskeletal and connective tissue disorders back pain	7.4% 2/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Nervous system disorders generalized muscle weakness	7.4% 2/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	14.8% 4/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	7.4% 2/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	4.2% 1/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Nervous system disorders Muscle weakness lower limb	7.4% 2/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	4.2% 1/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Nervous system disorders Cerebrospinal fluid leakage	7.4% 2/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Infections and infestations Graft vs host disease	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Skin and subcutaneous tissue disorders rash	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	7.4% 2/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	4.2% 1/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Skin and subcutaneous tissue disorders allergic reaction	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	4.2% 1/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
General disorders fever	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Gastrointestinal disorders diarrhea	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Musculoskeletal and connective tissue disorders neck. pain	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Nervous system disorders neuralgia	7.4% 2/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Nervous system disorders paresthesia	7.4% 2/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Skin and subcutaneous tissue disorders skin infection	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Nervous system disorders spasticity	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	4.2% 1/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
Nervous system disorders trigeminal nerve disorder	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
General disorders vertigo	3.7% 1/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	0.00% 0/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	4.2% 1/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.
General disorders Headache	66.7% 18/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	48.1% 13/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	66.7% 18/27 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.	54.2% 13/24 • Adverse events were documented in the intent-to-treat population for the duration of the 2 year study. Year 1 included the MSC-NP group year 1, and the saline group year 1. Study year 2 completed the compassionate crossover design, where subjects treated with saline in year 1 were treated with MSC-NP in year 2, and subjects treated with MSC-NP in year 1 received saline in year 2.

Additional Information

Saud Sadiq

Tisch MS Research Center of New York

Phone: 212-265-8070

Email: ssadiq@tischms.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place