Drugs / MSC-NTF cells
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | NurOwn | amyotrophic lateral sclerosis 28 | 2022-09-09 | “BrainStorm's BLA for NurOwn ® has a Prescription Drug User Fee Act (PDUFA) action date targeted to occur by December 8, 2023 .” brainstorm-cell.com ↗ “BrainStorm filed the BLA for ALS on September 9, 2022 .” brainstorm-cell.com ↗ “BrainStorm filed the BLA for ALS on September 9 , 2022.” brainstorm-cell.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01051882 | Jun 2011 → Dec 2012 | amyotrophic lateral sclerosis | Brainstorm-Cell Therapeutics | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT02017912 Comparator | May 2014 → Mar 2016 | amyotrophic lateral sclerosis | Brainstorm-Cell Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 40
| Date | Issuer | Release |
|---|---|---|
| 2025-06-16 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces New Survival Data from Expanded Access Program Cohort: Remarkably 90% of ALS Patients Survived Over 5 Years with NurOwn®BrainStorm_Logo brainstorm-cell.com ↗
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced new survival data from 10 participants in its Expanded Access Program (EAP) for NurOwn ® (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). |
| 2025-05-19 | Brainstorm-Cell Therapeutics | Regulatory BrainStorm Receives FDA Clearance to Initiate Phase 3b Trial of NurOwn® for ALSBrainStorm_Logo brainstorm-cell.com ↗
This clearance allows the company to proceed with patient enrollment. |
| 2024-10-28 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics Presented Positive Survival Data from NurOwn® Expanded Access Program at 2024 Annual NEALS MeetingBrainStorm_Logo brainstorm-cell.com ↗
Biomarker data suggest ALS patients may benefit from longer-term treatment with NurOwn |
| 2024-05-20 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics to Present New Biomarker Data Suggesting ALS Patients May Benefit From Longer-Term Treatment with NurOwnBrainStorm_Logo brainstorm-cell.com ↗
The data demonstrate a consistent reduction of neurofilament light (NfL) from baseline among participants who were randomized to receive NurOwn in the Phase 3 study. |
| 2024-04-10 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics Announces Peer-reviewed Publication of Biomarker Data from NurOwn's® Phase 3 Clinical Trial in ALSBrainStorm_Logo brainstorm-cell.com ↗
Treatment with debamestrocel led to significant changes in 64% of the forty-five analyzed biomarkers, spanning various pathways involved in ALS pathology. |
| 2023-07-07 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics Data Show Treatment with NurOwn Significantly Reduces NfL, a Key Biomarker of NeurodegenerationBrainStorm_Logo brainstorm-cell.com ↗
These data show that treatment with NurOwn significantly elevated markers of neuroprotection and lowered markers of neuroinflammation and neurodegeneration, including neurofilament light (NfL) over time compared to placebo in all trial participants. |
| 2022-11-07 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics Presents New Analyses from NurOwn's Phase 3 ALS Trial at the 21st Annual NEALS MeetingBrainStorm_Logo brainstorm-cell.com ↗
New post-hoc analyses that account for ALSFRS-R floor effects add to the robust body of evidence supporting a clinically meaningful treatment effect with NurOwn® in ALS |
| 2022-10-20 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics Presents NurOwn® Phase 2 Progressive MS Biomarker Data at the 38th ECTRIMS CongressBrainStorm_Logo brainstorm-cell.com ↗
Biomarker analyses show robust increases in cerebrospinal fluid neuroprotective biomarkers following NurOwn treatment |
| 2022-10-07 | Brainstorm-Cell Therapeutics | Results BrainStorm Presents New Biomarker Analyses from NurOwn's Phase 3 ALS Trial at the ALS ONE Research SymposiumBrainStorm_Logo brainstorm-cell.com ↗
NurOwn ® drove biomarker responses, affecting pathways related to neurodegeneration, neuroinflammation, and neuroprotection, that were consistent in participants with both advanced ALS and less advanced disease, confirming the importance of accounting for ALSFRS-R floor effects when evaluating clinical endpoints |
| 2022-09-15 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics Announces Peer Reviewed Publication of Results from the NurOwn® Phase 2 Progressive MS Trial in Multiple Sclerosis JournalBrainStorm_Logo brainstorm-cell.com ↗
Results from the Phase 2, single-arm, open-label study demonstrated NurOwn's safety and provided preliminary evidence of its efficacy in people with progressive MS. |
| 2022-05-31 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Presentations at June 2022 Scientific Conferences brainstorm-cell.com ↗
This presentation evaluated the impact of NurOwn therapy on visual outcomes (monocular and binocular LCLA) in progressive MS study participants in an open-label Phase 2 clinical trial in progressive MS (NCT 03799718). |
| 2021-12-13 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics Announces peer reviewed publication of NurOwn's® Phase 3 Study for ALS in Muscle and Nerve brainstorm-cell.com ↗
There are both biological and clinical signals of a treatment effect — as a community, we must review these carefully. |
| 2021-12-02 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics to Present New Biomarker Data on NurOwn® at the International Symposium on ALS/MND brainstorm-cell.com ↗
Key findings Robust and statistically significant CSF biomarker changes from baseline were observed with NurOwn treatment compared to placebo, particularly in biomarkers related to neuroinflammation, neurodegeneration, and neurotrophic factors. |
| 2021-11-29 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics Announces the Presentation of New Analyses from the Phase 3 Trial of NurOwn® in ALS at the 4th Annual ALS ONE Research Symposium brainstorm-cell.com ↗
In the subgroup of participants that are predicted by the ENCALS model to have long to very long survival, NurOwn treated participants had a greater percentage of responders compared to placebo (33% vs 14%). |
| 2021-10-18 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Data at NYSCF 2021 VIRTUAL Meeting brainstorm-cell.com ↗ |
| 2021-10-14 | Brainstorm-Cell Therapeutics | Results Phase 2 Clinical Trial Data of NurOwn® in Progressive MS Will Be Presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) brainstorm-cell.com ↗
The study achieved the primary endpoint of safety and tolerability. |
| 2021-10-06 | Brainstorm-Cell Therapeutics | Results BrainStorm to Present ALS Phase 3 Biomarker Analyses at Annual NEALS Meeting October 6th, 2021 brainstorm-cell.com ↗
The presentation will highlight CSF biomarkers that demonstrate high accuracy in predicting the primary clinical outcome using an unbiased stepwise logistic regression analysis. |
| 2021-10-01 | Brainstorm-Cell Therapeutics | Results BrainStorm to Present Phase 2 Progressive MS Study Results in Oral Presentation at 37th Congress of ECTRIMSBrainStorm_Logo brainstorm-cell.com ↗
The trial achieved the primary endpoint of safety and tolerability, and improvements were observed in secondary endpoints spanning neurologic function, cognition, and biomarkers. |
| 2021-05-25 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Data at ISCT 2021 New Orleans VIRTUAL Meeting brainstorm-cell.com ↗
Results from a study in a mouse model of lipopolysaccharide (LPS)-induced ARDS showed that intratracheal administration of NurOwn (MSC-NTF cells)-derived exosomes resulted in a statistically significant improvement in multiple lung parameters and superior results compared to MSC exosomes. |
| 2021-03-24 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Positive Topline Data in Phase 2 Study Evaluating NurOwn® as a Treatment for Progressive MS brainstorm-cell.com ↗
The study achieved the primary endpoint of safety and improvements were observed in secondary endpoints spanning neurologic function, cognition, and biomarkers. |
| 2021-02-22 | Brainstorm-Cell Therapeutics | Regulatory BrainStorm Announces High-Level FDA Feedback on NurOwn® ALS Clinical Development Program brainstorm-cell.com ↗
The FDA concluded from their initial review that the current level of clinical data does not provide the threshold of substantial evidence that FDA is seeking to support a Biologics License Application (BLA). |
| 2020-11-17 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Topline Results from NurOwn® Phase 3 ALS Study brainstorm-cell.com ↗
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today topline results from the Company's randomized, double-blind placebo-controlled Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for Amyotrophic lateral sclerosis (ALS). |
| 2020-10-19 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Outcomes at the Virtual New York Stem Cell Foundation Conference brainstorm-cell.com ↗
Results from a study in a mouse model of lipopolysaccharide (LPS)-induced ARDS showed that intratracheal administration of NurOwn (MSC-NTF cells) derived exosomes resulted in a statistically significant improvement in multiple lung parameters. |
| 2020-10-15 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Financial Results for the Third Quarter of 2020 and Provides a Corporate Update brainstorm-cell.com ↗
The manuscript describes NurOwn's immunomodulatory effects on T and B regulatory cell function, suggesting that its mechanism of action is broadly applicable in ALS, PMS and Alzheimer's disease. |
| 2020-08-19 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Publication of New Preclinical Data Supporting Proposed NurOwn® Mechanism in ALS, Progressive MS and Alzheimer's Disease brainstorm-cell.com ↗
In the preclinical experiments, a significant (p<0.0001) decrease of interferon-g secretion by peripheral blood mononuclear cells (PBMC) in the presence of NurOwn® was demonstrated. |
| 2020-07-23 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Groundbreaking Pre-Clinical Study of NurOwn® derived Exosome-Based Treatment for COVID-19 ARDS brainstorm-cell.com ↗
Results from a study in a mouse model of lipopolysaccharide (LPS)-induced ARDS showed that intratracheal administration of NurOwn® (MSC-NTF cells) derived exosomes resulted in a statistically significant improvement in multiple lung parameters. |
| 2020-05-04 | Brainstorm-Cell Therapeutics | Results BrainStorm Presents New Data Highlighting NurOwn® Immunomodulation in Neurology brainstorm-cell.com ↗
The immunomodulatory properties of MSC-NTF cells, including their effects on T and B regulatory cells, and the observed increase in IL-10 secretion, may be an important contributor to the potential therapeutic benefits of NurOwn in ALS and progressive MS. |
| 2020-02-11 | Brainstorm-Cell Therapeutics | Regulatory BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn® Regulatory Pathway for Approval in ALS brainstorm-cell.com ↗
Furthermore, based on their detailed data assessment, they are committed to work collaboratively with BrainStorm to identify a regulatory pathway forward, including opportunities to expedite statistical review of data from the Phase 3 trial. |
| 2019-12-19 | Brainstorm-Cell Therapeutics | Results NurOwn® Data Safety Monitoring Board Recommends MS Phase 2 Clinical Trial Continue brainstorm-cell.com ↗
After careful review of all available clinical trial data, the DSMB unanimously concluded “the study should continue as planned without any protocol modification”. |
| 2019-11-20 | Brainstorm-Cell Therapeutics | Results BrainStorm Cell Therapeutics Announces Publication of NurOwn® ALS Phase 2 Randomized Clinical Trial Data in Neurology brainstorm-cell.com ↗
The clinical trial confirmed that a single transplantation of MSC-NTF (NurOwn) cells was safe and well-tolerated. |
| 2019-10-28 | Brainstorm-Cell Therapeutics | Results NurOwn® Data Safety Monitoring Board Recommends ALS Phase 3 Clinical Trial Continue brainstorm-cell.com ↗
After reviewing all of the safety data as of September 30 th, the DSMB has recommended the study continue without any changes in the protocol. |
| 2019-01-22 | Brainstorm-Cell Therapeutics | Regulatory BrainStorm Granted Additional Patent for NurOwn® in Israel brainstorm-cell.com ↗
NEW YORK , Jan. 22, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for debilitating neurodegenerative diseases, today announced that the Israel Patent Office has granted an additional patent titled “Methods of Generating Mesenchymal Stem Cells which Secrete Neurotrophic Factors.” |
| 2018-12-17 | Brainstorm-Cell Therapeutics | Regulatory FDA Accepts BrainStorm’s NurOwn® IND Application for Progressive Multiple Sclerosis brainstorm-cell.com ↗ |
| 2018-10-04 | Brainstorm-Cell Therapeutics | Results BrainStorm Poster Receives Clinical Abstract Award at NEALS Conference brainstorm-cell.com ↗
The biomarker data demonstrated increases in miRNA 132 and miRNA 146a and statistically significant decreases in MCP-1, SDF-1, CHIT-1 and Caspase-3 levels in CSF following a single MSC-NTF cell transplantation in the NurOwn® Phase 2 trial. |
| 2018-09-13 | Brainstorm-Cell Therapeutics | Regulatory BrainStorm Granted New U.S. Patent for Industrial Scale Manufacturing of NurOwn® brainstorm-cell.com ↗ |
| 2018-02-07 | Brainstorm-Cell Therapeutics | Results BrainStorm's NurOwn® Phase 2 ALS Clinical Trial and Biomarker Abstracts Accepted for Platform Presentations at the 70th Annual American Academy of Neurology Meeting in Los Angeles, California brainstorm-cell.com ↗
The CSF biomarker data confirms that micro-RNA released by NurOwn ® may contribute to its therapeutic effect in ALS |
| 2017-11-09 | Brainstorm-Cell Therapeutics | Results New Peer Reviewed Publication Shows That BrainStorm's NurOwn® Has a Unique miRNA Signature brainstorm-cell.com ↗
The study shows that BrainStorm's proprietary differentiation process modulates miRNA expression, leading to a unique miRNA signature. |
| 2017-04-19 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Publication of NurOwn® Autism Research Study brainstorm-cell.com ↗
The authors concluded that NurOwn® treatment markedly reduced autistic behavior in BTBR mice for an extended period after a single cell transplantation, and that NurOwn® is superior to MSC treatment, as demonstrated in its beneficial effect on communication skills and stereotypic behavior. |
| 2016-07-18 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Positive Top Line Results from the U.S. Phase 2 Study of NurOwn® in Patients with Amyotrophic Lateral Sclerosis (ALS) brainstorm-cell.com ↗
The study achieved its primary objective, demonstrating that NurOwn was safe and well tolerated. |
| 2015-01-05 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Final Analysis of Phase 2a ALS Study Showing Nearly All Subjects Experienced Clinical Benefit from NurOwn™ brainstorm-cell.com ↗
Importantly, nearly all subjects in this study experienced clinical benefit from treatment with NurOwn™. |
All press releases naming this drug 40 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MSC-NTF cells | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02017912 ↗ |
| Modality | Cell therapy | “The primary end points of the studies were safety and tolerability of this cell therapy.” PMID 26751635 ↗ Mar 2016 |
| Route | Intramuscular | “MSC-NTF will be transplanted by IM or IT injection to the early and progressive ALS patients respectively.” NCT01051882 ↗ |
| Route | Intrathecal | “MSC-NTF will be transplanted by IM or IT injection to the early and progressive ALS patients respectively.” NCT01051882 ↗ |