Policy & Regulation
Stem Cell and Research Therapy Publishes Preclinical Data Highlighting the Potential of a NurOwn Derived Exosome-Based Treatment for COVID-19 ARDS
20 January 2021 - - US-based adult stem cell therapies developer BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) is highlighting the peer-reviewed publication of a preclinical study in the journal Stem Cell and Research Therapy, the company said.

The study, entitled "MSC-NTF (NurOwn) exosomes: a novel therapeutic modality in the mouse LPS-induced ARDS model," evaluated the use of NurOwn (MSC-NTF cell) derived exosomes in a mouse model of acute respiratory distress syndrome.

ARDS is a type of respiratory failure that is frequently associated with COVID-19 and mediated by dysregulated cytokine production.

While there are currently no effective therapies to prevent or reverse ARDS, mesenchymal stem cell -derived exosomes have been suggested as a potential novel treatment option due to their ability to penetrate deep into tissues and efficiently deliver immunomodulatory molecules.

Results from the recently published study showed that intratracheal administration of NurOwn derived exosomes led to a statistically significant reduction in lung disease severity score (p < 0.05; based on criteria set forth by the American Thoracic Society Documents: Matute-Bello et al., Am J Respir Cell Mol Biol 44;725-738, 2011) and improvements in several additional clinically relevant lipopolysaccharide -induced ARDS markers such as lung function, fibrin presence, neutrophil accumulation, cytokine expression, and blood oxygenation levels.

Notably, these improvements were significantly superior to those observed following administration of naïve MSC-derived exosomes.

The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders.

MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells that have been expanded and differentiated ex vivo.

MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors.

Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

BrainStorm Cell Therapeutics is a developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases.

The company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement.

Autologous MSC-NTF cells have received Orphan Drug status designation from the US Food and Drug Administration and the European Medicines Agency for the treatment of amyotrophic lateral sclerosis.

BrainStorm has completed a phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989).

BrainStorm is in active discussions with the FDA to identify regulatory pathways that may support NurOwn's approval in ALS.

BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis.

The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter 2021.
Login
Username:

Password: