Multiple Sclerosis, Chronic ProgressivePhase 2NCT03799718
Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS
A Phase 2 study testing NurOwn (MSC-NTF cells) in people with Multiple Sclerosis, Chronic Progressive, run by Brainstorm-Cell Therapeutics at 4 sites in United States.
Trial summary
A multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at multiple investigational study sites. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Chronic Progressive
- What is being tested?
- NurOwn (MSC-NTF cells)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Mar 2019to 30 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ages 18 to 65 years old, inclusive, at the Screening Visit.
- Clinical diagnosis of Progressive MS (Primary and Secondary) based on the 2017 revised MacDonald Criteria and confirmation by the Investigator that the disease has entered the progressive stage for at least 6 months prior to enrollment.
- No evidence of clinical MS relapse or high dose pulse corticosteroid treatment within 6 months prior to screening
- Disability status at screening with an Expanded Disability Status Scale (EDSS) 3.0-6.5, inclusive.
- Able to walk 25 feet in 60 seconds or less.
- Stable dose of non-excluded MS Disease Modifying Therapy for at least 6 months prior to Screening Visit (Visit 1).
- Women of childbearing potential shall either be surgically sterile, or must agree not to become pregnant for the duration of the study. Women must be willing to undergo a serum pregnancy test at screening, and at the conclusion of the study. Participants of childbearing potential must agree to use a medically approved form of birth control (abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant) throughout the duration of the study and for at least 3 months following the last transplantation. For those women who are sexually active and using oral contraceptives, a second form of barrier contraception is required. Men must be willing to consistently use two forms of contraceptive if their partners are of childbearing age.
- Capable of providing informed consent and willing and able to follow study procedures, including willingness to undergo multiple/repeated lumbar puncture.
Who cannot join
- Prior stem cell therapy of any kind.
- Active participation in any other MS interventional study or use of unapproved MS investigational therapy within 90 days prior to the Screening Visit (Visit 1).
- Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow biopsy, or inability to tolerate study procedures for any other reason.
- History of clinically significant autoimmune disease (excluding thyroid disease) that may confound study results, in the opinion of the Investigator and the medical monitor, myelodysplastic or myeloproliferative disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe scoliosis.
- Any unstable clinically significant medical condition other than multiple sclerosis (e.g., within six months of Screening Visit (Visit 1), had myocardial infarction, angina pectoris, and/or congestive heart failure), treatment with anticoagulants that, in the opinion of the investigator, would compromise the safety of participants.
- Any history of malignancy within the previous 5 years, except for non-melanoma localized skin cancers (with no evidence of metastasis, significant invasion, or reoccurrence within three years of Screening Visit (Visit 1)).
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- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value >3.0 times the upper normal limit.
- Serum creatinine value >2.0 times the upper normal limit.
- Positive test for Hepatitis B (HBV; surface antigen (HBsAg) and antibodies to core antigen (IgG and IgM anti-HBc)), Hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
- Current use of immunosuppressant medication or use of such medication within 6 months of study enrollment (aside from Rituximab or other approved B-cell immunotherapy). Alemtuzumab (Lemtrada), Cladribine (NDA submitted), Natalizumab (Tysabri), S1P modulators (Gilenya) are excluded for safety reasons due to the known risk of systemic autoimmune disease, malignancy, opportunistic infections, and cardiovascular toxicity associated with these therapies, as well as theoretical effects on MSC-NTF cell homing and migration, that may be associated with Natalizumab and/or S1P modulators (Gilenya).
- Any history of acquired or inherited immune deficiency syndrome.
- Any history of either substance abuse within the past year, or unstable psychiatric disease according to the Investigator's judgment.
- Pregnant women or women currently breastfeeding.
- Subjects for whom MRI is contraindicated (i.e., have a pacemaker or other metallic implanted device, or are unable to remain in the machine for period of time needed to acquire a scan.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
University of Southern California
Los Angeles, California, 90033
The Mount Sinai Hospital
New York, New York, 10029
Stanford University School of Medicine
Redwood City, California, 94305
About this study
Official title: A Phase 2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of Repeated Administration of NurOwn® [Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NTF), MSC-NTF] Cells in Participants With Progressive MS
A multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at multiple investigational study sites.
Read the detailed description
An open-label study with a single treatment arm involving 20 participants with progressive MS at multiple investigational study sites. After providing informed consent, participants meeting the inclusion and exclusion criteria will be randomized and approximately 4 weeks later will undergo a bone-marrow aspiration (BMA). Each participants will receive three Intrathecal cell transplantations within 16 weeks and will be followed for 12 weeks for safety and efficacy.
- Conditions
- Multiple Sclerosis, Chronic Progressive
- Being tested
- NurOwn (MSC-NTF cells)
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NurOwn (MSC-NTF cells)Biological
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
| Study group | Role | What they receive |
|---|---|---|
| NurOwn (MSC-NTF cells) | Experimental | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors Receives: Biological: NurOwn (MSC-NTF cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events
Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study.
Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment.
Measured: Up to 28 weeks post-first treatment
Secondary outcomes (9)
Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT)
25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes.
The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded.
Higher values represent worse outcomes.
Measured: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed
≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely.
The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes
Measured: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT
The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.
Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome.
Measured: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28
Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome.
Measured: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12)
The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality.
Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome.
Measured: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level
The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome.
Measured: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score
Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome.
Measured: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment
Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome
Measured: From Baseline (pre-first treatment) to 16 weeks post first treatment
Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment
Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome
Measured: From Baseline (pre-first treatment) to 16 weeks post first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start13 Mar 2019
- Primary completion11 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Sclerosis, Chronic ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainstorm-Cell Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Cohen, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799718
- Sponsor's protocol ID
- BCT-101-US
- Status last verified
- Nov 2023
- First submitted
- 7 Jan 2019
- Last updated
- 4 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of Repeated Administration of NurOwn® [Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NTF), MSC-NTF] Cells in Participants With Progressive MS
- ClinicalTrials.gov ID
- NCT03799718
- Acronym / sponsor ID
- BCT-101-US
- Conditions
- Multiple Sclerosis, Chronic Progressive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Brainstorm-Cell TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at multiple investigational study sites.
Detailed description
An open-label study with a single treatment arm involving 20 participants with progressive MS at multiple investigational study sites. After providing informed consent, participants meeting the inclusion and exclusion criteria will be randomized and approximately 4 weeks later will undergo a bone-marrow aspiration (BMA). Each participants will receive three Intrathecal cell transplantations within 16 weeks and will be followed for 12 weeks for safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| NurOwn (MSC-NTF cells) | Experimental | Biological: NurOwn (MSC-NTF cells)Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females ages 18 to 65 years old, inclusive, at the Screening Visit.
- Clinical diagnosis of Progressive MS (Primary and Secondary) based on the 2017 revised MacDonald Criteria and confirmation by the Investigator that the disease has entered the progressive stage for at least 6 months prior to enrollment.
- No evidence of clinical MS relapse or high dose pulse corticosteroid treatment within 6 months prior to screening
- Disability status at screening with an Expanded Disability Status Scale (EDSS) 3.0-6.5, inclusive.
- Able to walk 25 feet in 60 seconds or less.
Key exclusion criteria (14 listed)
- Prior stem cell therapy of any kind.
- Active participation in any other MS interventional study or use of unapproved MS investigational therapy within 90 days prior to the Screening Visit (Visit 1).
- Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow biopsy, or inability to tolerate study procedures for any other reason.
- History of clinically significant autoimmune disease (excluding thyroid disease) that may confound study results, in the opinion of the Investigator and the medical monitor, myelodysplastic or myeloproliferative disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe scoliosis.
- Any unstable clinically significant medical condition other than multiple sclerosis (e.g., within six months of Screening Visit (Visit 1), had myocardial infarction, angina pectoris, and/or congestive heart failure), treatment with anticoagulants that, in the opinion of the investigator, would compromise the safety of participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NurOwn (MSC-NTF cells)Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors | Biological | NurOwn (MSC-NTF cells) |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events
Time frame: Up to 28 weeks post-first treatment
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.
9 secondary outcomes
Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT)
Time frame: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed
Time frame: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT
Time frame: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28
Time frame: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12)
Time frame: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level
Time frame: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score
Time frame: From Baseline (pre-first treatment) to 28 weeks post-first treatment
Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment
Time frame: From Baseline (pre-first treatment) to 16 weeks post first treatment
Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment
Time frame: From Baseline (pre-first treatment) to 16 weeks post first treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Cohen, MD principal investigator
The Cleveland Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NurOwn (MSC-NTF cells) in people with Multiple Sclerosis, Chronic Progressive, run by Brainstorm-Cell Therapeutics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (time frame: Up to 28 weeks post-first treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.