Secondary Progressive Multiple Sclerosis (SPMS)Phase 2NCT06961383
Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis
A Phase 2 study testing NG01 - Autologous bone marrow derived human stromal cells and Sodium Chloride 0.9% in people with Secondary Progressive Multiple Sclerosis (SPMS), run by NeuroGenesis Ltd. at 2 sites in 2 countries.
Trial summary
The goal of this clinical trial is to assess the safety and efficacy of repeated intrathecal (IT) injection of NG01, autologous bone marrow derived human stromal cells, in treating Secondary Progressive Multiple Sclerosis (SPMS), compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis (SPMS)
- What is being tested?
- NG01 - Autologous bone marrow derived human stromal cells and Sodium Chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2025to 1 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participants aged 18 to 65 years old.
- Diagnosis of SPMS.
- Documented EDSS worsening over the 2 years prior to study entry of ≥1 point for participants with EDSS <6.0 at screening, and ≥0.5 point for participants with EDSS ≥6.0 at screening, or a documented worsening of at least 20% in the T25FW. If documented T25fW or EDSS is not available, a written summary of the clinical evidence of disability worsening over the previous 2 years and retrospective assessment of EDSS score from data up to 2 years prior to screening, must be submitted for central review by adjudication committee.
- EDSS at the screening visit from 3.5 to 6.5 at screening.
- T25FW at the screening visit of from 8.0 to 25 seconds.
Who cannot join
- Documented clinical relapse during the 24 months prior to enrollment and/or evidence of enhancing lesions on an MRI obtained at screening.
- Pregnancy, breast feeding or women with childbearing potential without an acceptable form of contraception.
- History of a general chronic handicapping/incapacitating disease other than MS.
- Participants with clotting disorders
- Participants unable to undergo an MRI scan.
- Participants with uncontrolled hepatic disorders, renal or cardiovascular disease, or cancer.
Show all 14Show fewer
- Laboratory tests out of normal ranges considered by the investigator as clinically significant.
- Participants with history or current alcohol abuse or drug addiction.
- Untreated or uncontrolled psychiatric disorders, or positive suicidal risk assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
- Participation in another research study involving an investigational product (IP) in the 90 days prior to inclusion, or planned use of another IP during the study duration.
- Participants who have ever received NG01/MSCs treatment.
- Participants who, in the opinion of the investigator, are unable to fully comprehend the consenting process or likely to be non-compliant with the study procedures or for whom long-term follow-up seems difficult to achieve.
- Relapse occurring between screening and randomization.
- Less than 6 months of the current disease-modifying therapy
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center - Neurology
Miami, Florida, 33136
Flavia Nelson, MD, 305-243-4015, fxn133@med.miami.edu
Flavia Nelson, MD
Israel1 site
Hadassah University Hospital
Jerusalem
Panayiota Petrou, MD, 972-2-6776639, petroupanayiota@gmail.com
About this study
Official title: A Double Blind, Randomized, Placebo Controlled Phase 2b Study to Evaluate the Safety and Clinical Efficacy of Treatment With the Autologous Cell Therapy Product, NG01, in Patients With Secondary Progressive Multiple Sclerosis
The goal of this clinical trial is to assess the safety and efficacy of repeated intrathecal (IT) injection of NG01, autologous bone marrow derived human stromal cells, in treating Secondary Progressive Multiple Sclerosis (SPMS), compared to placebo.
The study will assess the proportion of participants demonstrating improvement in walking ability, defined as a reduction in the average time to complete the Timed 25-Foot Walk (T25FW) at 6, 9, and 12 months compared to baseline. This will be analyzed by the mean change in walking speed across these time points. The study will also evaluate the incidence and nature of treatment-emergent adverse events (AEs).
Participants will receive intrathecal administrations of NG01, by lumbar puncture, and will be followed up for 6 months after their fourth administration.
Read the detailed description
This is a multi-center, international Phase 2b, dose finding, randomized, double-blinded, placebo-controlled, three arm study, designed to assess the safety and efficacy of 4 IT administrations of NG01, compared to placebo, with a 4-month run-in period followed by a period of 9 months treatment with 6 months of follow-up, in patients with SPMS. Participants will continue to receive their customary MS treatment regimen at a stable dose.
The study will enroll 45 participants with secondary progressive multiple sclerosis (SPMS), randomized in a 1:1:1 ratio, to receive four intrathecal administrations-3 months apart over a 9-month period-of either high-dose NG01, low-dose NG01, or placebo. All participants will undergo clinical and safety assessments throughout the 9-month treatment period.
Upon completion of the 9-month treatment period, double-blind treatment and assessment period, participants will be followed clinically for an additional 6 months. The primary clinical outcome assessment and magnetic resonance imaging (MRI) acquisition for imaging assessments will occur post-treatment initiation (baseline).
- Being tested
- NG01 - Autologous bone marrow derived human stromal cells, Sodium Chloride 0.9%
- Keywords
- Secondary progressive multiple sclerosis, Multiple sclerosis, Autologous cell therapy
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG01 - Autologous bone marrow derived human stromal cellsBiological
NG01 is a cellular therapy product of autologous stromal cells derived from the bone marrow of multiple sclerosis (MS) patients. NG01 is provided as a cell suspension for intrathecal injection.
Sodium Chloride 0.9%Other
The placebo for use in the NG01 clinical trial is 0.9% Sodium Chloride Solution for Injection
| Study group | Role | What they receive |
|---|---|---|
| 100x10^6 cells | Experimental | 15 participants with SPMS will receive 4 IT administrations of NG01 (100×10^6 cells), 3 months apart Receives: Biological: NG01 - Autologous bone marrow derived human stromal cells |
| 50x10^6 cells | Experimental | 15 participants with SPMS will receive 4 IT administrations of NG01 (50×10^6 cells), 3 months apart Receives: Biological: NG01 - Autologous bone marrow derived human stromal cells |
| Placebo | Placebo comparator | 15 participants with SPMS will receive 4 IT administrations of placebo solution, 3 months apart Receives: Other: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Ability
Proportion of participants who achieved improvement in walking ability over baseline by mean change in walking speed based on the Timed 25-Foot Walk (T25FW) test, averaged over visits at month-6, month-9 and month-12. Baseline is defined as the change in average timed walk compared to baseline (average timed walk at 6-, 9-, 12-months minus baseline < 0)
Measured: 12 months
Incidence of Treatment-Emergent Adverse Events (AEs)
The occurrence of treatment-related AEs will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5 following enrollment, NG01 or placebo administrations (intrathecal), and during the 6 months of follow-up.
Measured: 15 months
Secondary outcomes (10)
Walking Speed
The change in walking speed will be assessed based on the average of two separate T25FW tests obtained during each study visit.
The proportion of responders with 10, 15 or 20% improvement in walking speed will be assessed based on the average of two separate T25FW tests obtained during each study visit.
Measured: 12 months
Neuroimaging Parameters - Change in T2-hyperintense Lesion
Change in T2-hyperintense lesion number and volume will be assessed by 3 tesla (3T) brain Magnetic Resonance Imaging (MRI) using automated volumetric analysis.
Measured: 12 months
Neuroimaging Parameters - Change in T1-hypointense Lesion
Change in T1-hypointense lesion volume will be assessed by 3 tesla (3T) brain MRI using automated volumetric analysis.
Measured: 12 months
Neuroimaging Parameters - Change in Brain and Thalamus
Change in whole brain and thalamic volume will be assessed by 3 tesla (3T) brain MRI using automated volumetric analysis
Measured: 12 months
Efficacy - Finger Dexterity
Finger dexterity will be assessed by the 9-hole peg test (9HPT)
Measured: 12 months
Quality of Life (QoL)
Quality of Life (QoL) will be assessed by 12-Item Short Form Survey (SF-12).
Patients fill out a 12-question survey which is then scored by a clinician or researcher. The survey includes the following domains:
- Limitations in physical activities because of health problems.
- Limitations in social activities because of physical or emotional problems
- Limitations in usual role activities because of physical health problems
- Bodily pain
- General mental health (psychological distress and well-being)
- Limitations in usual role activities because of emotional problems
- Vitality (energy and fatigue)
- General health perceptions
Measured: 12 months
Fatigue
Level of fatigue will be assessed by Modified Fatigue Impact Scale (MIFS-21). The scores are 0 (Never), 1(Rarely), 2 (Sometimes), 3 (Often), 4 (Almost always).
Physical Subscale can range from 0 to 36. Cognitive Subscale can range from 0 to 40. Psychosocial Subscale can range from 0 to 8. The subscale scores are computed by adding raw scores on specific questions, in accordance with questionnaire instructions.
Total MFIS Score can range from 0 to 84. It is computed by adding scores on the physical, cognitive, and psychosocial subscales.
Measured: 12 months
Walking ability
Walking will be assessed by 12-item Multiple Sclerosis Walking Scale (MSWS-12). The original scoring provides options 1-5 for each item, with 1 meaning no limitation and 5 meaning extreme limitation on the gait-related item. In a version 2, three items are scored 1-3, and nine items are scored 1-5.
Measured: 12 months
Efficacy - Congnition
Cognitive assessment will be done using the Symbol Digit Modalities Test (SDMT)
Measured: 12 months
Change in Disability
Proportion of participants with no increase in month-3 confirmed disability worsening (CDW) will be assessed by Expanded Disability Status Scale (EDSS). The EDSS ranges from 0 to 10. Scores are in half unit steps - 3, 3.5, 4 and so on. The greater the level of disability, the higher the score out of ten.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Secondary Progressive Multiple Sclerosis (SPMS)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroGenesis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961383
- Sponsor's protocol ID
- NG01-P2b-SPMS-US
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petrou P, Gothelf Y, Argov Z, Gotkine M, Levy YS, Kassis I, Vaknin-Dembinsky A, Ben-Hur T, Offen D, Abramsky O, Melamed E, Karussis D. Safety and Clinical Effects of Mesenchymal Stem Cells Secreting Neurotrophic Factor Transplantation in Patients With Amyotrophic Lateral Sclerosis: Results of Phase 1/2 and 2a Clinical Trials. JAMA Neurol. 2016 Mar;73(3):337-44. doi: 10.1001/jamaneurol.2015.4321.
PubMed 26751635Petrou P, Kassis I, Ginzberg A, Halimi M, Yaghmour N, Abramsky O, Karussis D. Long-Term Clinical and Immunological Effects of Repeated Mesenchymal Stem Cell Injections in Patients With Progressive Forms of Multiple Sclerosis. Front Neurol. 2021 May 31;12:639315. doi: 10.3389/fneur.2021.639315. eCollection 2021.
PubMed 34135843Petrou P, Kassis I, Levin N, Paul F, Backner Y, Benoliel T, Oertel FC, Scheel M, Hallimi M, Yaghmour N, Hur TB, Ginzberg A, Levy Y, Abramsky O, Karussis D. Beneficial effects of autologous mesenchymal stem cell transplantation in active progressive multiple sclerosis. Brain. 2020 Dec 1;143(12):3574-3588. doi: 10.1093/brain/awaa333.
PubMed 33253391Petrou P, Kassis I, Yaghmour NE, Ginzberg A, Karussis D. A phase II clinical trial with repeated intrathecal injections of autologous mesenchymal stem cells in patients with amyotrophic lateral sclerosis. Front Biosci (Landmark Ed). 2021 Oct 30;26(10):693-706. doi: 10.52586/4980.
PubMed 34719198
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled Phase 2b Study to Evaluate the Safety and Clinical Efficacy of Treatment With the Autologous Cell Therapy Product, NG01, in Patients With Secondary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06961383
- Acronym / sponsor ID
- NG01-P2b-SPMS-US
- Keywords
- Secondary progressive multiple sclerosis, Multiple sclerosis, Autologous cell therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- NeuroGenesis Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the safety and efficacy of repeated intrathecal (IT) injection of NG01, autologous bone marrow derived human stromal cells, in treating Secondary Progressive Multiple Sclerosis (SPMS), compared to placebo.
The study will assess the proportion of participants demonstrating improvement in walking ability, defined as a reduction in the average time to complete the Timed 25-Foot Walk (T25FW) at 6, 9, and 12 months compared to baseline. This will be analyzed by the mean change in walking speed across these time points. The study will also evaluate the incidence and nature of treatment-emergent adverse events (AEs).
Participants will receive intrathecal administrations of NG01, by lumbar puncture, and will be followed up for 6 months after their fourth administration.
Detailed description
This is a multi-center, international Phase 2b, dose finding, randomized, double-blinded, placebo-controlled, three arm study, designed to assess the safety and efficacy of 4 IT administrations of NG01, compared to placebo, with a 4-month run-in period followed by a period of 9 months treatment with 6 months of follow-up, in patients with SPMS. Participants will continue to receive their customary MS treatment regimen at a stable dose.
The study will enroll 45 participants with secondary progressive multiple sclerosis (SPMS), randomized in a 1:1:1 ratio, to receive four intrathecal administrations-3 months apart over a 9-month period-of either high-dose NG01, low-dose NG01, or placebo. All participants will undergo clinical and safety assessments throughout the 9-month treatment period.
Upon completion of the 9-month treatment period, double-blind treatment and assessment period, participants will be followed clinically for an additional 6 months. The primary clinical outcome assessment and magnetic resonance imaging (MRI) acquisition for imaging assessments will occur post-treatment initiation (baseline).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100x10^6 cells | Experimental | Biological: NG01 - Autologous bone marrow derived human stromal cells15 participants with SPMS will receive 4 IT administrations of NG01 (100×10^6 cells), 3 months apart |
| 50x10^6 cells | Experimental | Biological: NG01 - Autologous bone marrow derived human stromal cells15 participants with SPMS will receive 4 IT administrations of NG01 (50×10^6 cells), 3 months apart |
| Placebo | Placebo comparator | Other: Sodium Chloride 0.9%15 participants with SPMS will receive 4 IT administrations of placebo solution, 3 months apart |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants aged 18 to 65 years old.
- Diagnosis of SPMS.
- Documented EDSS worsening over the 2 years prior to study entry of ≥1 point for participants with EDSS <6.0 at screening, and ≥0.5 point for participants with EDSS ≥6.0 at screening, or a documented worsening of at least 20% in the T25FW. If documented T25fW or EDSS is not available, a written summary of the clinical evidence of disability worsening over the previous 2 years and retrospective assessment of EDSS score from data up to 2 years prior to screening, must be submitted for central review by adjudication committee.
- EDSS at the screening visit from 3.5 to 6.5 at screening.
- T25FW at the screening visit of from 8.0 to 25 seconds.
Key exclusion criteria (14 listed)
- Documented clinical relapse during the 24 months prior to enrollment and/or evidence of enhancing lesions on an MRI obtained at screening.
- Pregnancy, breast feeding or women with childbearing potential without an acceptable form of contraception.
- History of a general chronic handicapping/incapacitating disease other than MS.
- Participants with clotting disorders
- Participants unable to undergo an MRI scan.
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 |
|---|---|---|
| NG01 - Autologous bone marrow derived human stromal cellsNG01 is a cellular therapy product of autologous stromal cells derived from the bone marrow of multiple sclerosis (MS) patients. NG01 is provided as a cell suspension for intrathecal injection. | Biological | 100x10^6 cells, 50x10^6 cells |
| Sodium Chloride 0.9%The placebo for use in the NG01 clinical trial is 0.9% Sodium Chloride Solution for Injection | Other | Placebo |
Primary outcome
Walking Ability
Time frame: 12 months
Proportion of participants who achieved improvement in walking ability over baseline by mean change in walking speed based on the Timed 25-Foot Walk (T25FW) test, averaged over visits at month-6, month-9 and month-12. Baseline is defined as the change in average timed walk compared to baseline (average timed walk at 6-, 9-, 12-months minus baseline < 0)
Incidence of Treatment-Emergent Adverse Events (AEs)
Time frame: 15 months
The occurrence of treatment-related AEs will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5 following enrollment, NG01 or placebo administrations (intrathecal), and during the 6 months of follow-up.
10 secondary outcomes
Walking Speed
Time frame: 12 months
Neuroimaging Parameters - Change in T2-hyperintense Lesion
Time frame: 12 months
Neuroimaging Parameters - Change in T1-hypointense Lesion
Time frame: 12 months
Neuroimaging Parameters - Change in Brain and Thalamus
Time frame: 12 months
Efficacy - Finger Dexterity
Time frame: 12 months
Quality of Life (QoL)
Time frame: 12 months
Fatigue
Time frame: 12 months
Walking ability
Time frame: 12 months
Efficacy - Congnition
Time frame: 12 months
Change in Disability
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Results publication: PubMed 26751635Petrou P, Gothelf Y, Argov Z, Gotkine M, Levy YS, Kassis I, Vaknin-Dembinsky A, Ben-Hur T, Offen D, Abramsky O, Melamed E, Karussis D. Safety and Clinical Effects of Mesenchymal Stem Cells Secreting Neurotrophic Factor Transplantation in Patients With Amyotrophic Lateral Sclerosis: Results of Phase 1/2 and 2a Clinical Trials. JAMA Neurol. 2016 Mar;73(3):337-44. doi: 10.1001/jamaneurol.2015.4321.
- Results publication: PubMed 34135843Petrou P, Kassis I, Ginzberg A, Halimi M, Yaghmour N, Abramsky O, Karussis D. Long-Term Clinical and Immunological Effects of Repeated Mesenchymal Stem Cell Injections in Patients With Progressive Forms of Multiple Sclerosis. Front Neurol. 2021 May 31;12:639315. doi: 10.3389/fneur.2021.639315. eCollection 2021.
- Results publication: PubMed 33253391Petrou P, Kassis I, Levin N, Paul F, Backner Y, Benoliel T, Oertel FC, Scheel M, Hallimi M, Yaghmour N, Hur TB, Ginzberg A, Levy Y, Abramsky O, Karussis D. Beneficial effects of autologous mesenchymal stem cell transplantation in active progressive multiple sclerosis. Brain. 2020 Dec 1;143(12):3574-3588. doi: 10.1093/brain/awaa333.
- Results publication: PubMed 34719198Petrou P, Kassis I, Yaghmour NE, Ginzberg A, Karussis D. A phase II clinical trial with repeated intrathecal injections of autologous mesenchymal stem cells in patients with amyotrophic lateral sclerosis. Front Biosci (Landmark Ed). 2021 Oct 30;26(10):693-706. doi: 10.52586/4980.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NG01 - Autologous bone marrow derived human stromal cells and Sodium Chloride 0.9% in people with Secondary Progressive Multiple Sclerosis (SPMS), run by NeuroGenesis Ltd. at 2 sites in 2 countries.
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 5 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: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flavia Nelson, MD (305-243-4015, fxn133@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Ability (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06961383, which also lists 4 linked publications.
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 7 May 2025.