Science

Autologous Cellular Therapy

Autologous cellular therapy has recently emerged as a credible and practical treatment option for cancer and other highly debilitating diseases.

BrainStorm is focused on developing clinical-stage autologous cellular therapy as a potentially transformative approach to treating neurodegenerative diseases.

BrainStorm has developed a targeted, innovative, proprietary and validated autologous cellular technology platform (NurOwn®) for the treatment of neurodegenerative diseases.

MSC-NTF Cells

Autologous MSC-NTF cells represent a promising therapeutic candidate by targeting disease pathways important in neurodegenerative disorders.

Autologous MSC-NTF cells are produced from the patient’s own bone marrow-derived MSCs that have been differentiated in culture. 

A patient’s own MSCs are harvested and differentiated to secrete high levels of NTFs using a proprietary technology. 
The differentiated MSCs, known as MSC-NTF cells, are then harvested and prepared for injection into the patient. The MSC-NTF cells are not genetically modified.

Autologous MSC-NTF cells represent an innovative cellular therapy approach that 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.
BEFORE DIFFERENTIATION: MSCs
After Differentiation: MSC-NTF Cells

Source: BrainStorm, Data on file. Detection of GDNF expression in MSC and MSC-NTF cells by immunofluorescence.

NTF Levels before and after differentation
Autologous MSC-NTF cells secrete a unique profile of bioactive molecules, including NTFs, microRNA and cytokines
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Following intrathecal administration, the autologous MSC-NTF cells may activate neuroprotective and immunomodulatory pathways
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MSC-NTF Cell Production

BrainStorm has pioneered production of autologous MSC-NTF cells. We have developed proprietary methods to engineer, produce, and purify autologous MSC-NTF cells at a scale and quality necessary to bring MSC-NTF therapeutics to patients with debilitating neurodegenerative diseases.

Each treatment consists of a ready-for-injection syringe containing 100-125 x 106 freshly-harvested autologous MSC-NTF cells in a volume of 4 mL. The MSC-NTF cells are autologous and therefore unlikely to induce an adverse immune response.

BrainStorm has entered into agreements with Dana-Farber Cancer Institute (Dana-Farber) in Boston, Massachusetts and the City of Hope National Medical Center in Duarte, California to provide clean room facilities for production of autologous MSC-NTF cells.

PATENTS

BrainStorm has a robust intellectual property portfolio.

We hold rights to clinical development and commercialization of the NurOwn® technology platform through an exclusive, worldwide licensing agreement.

RECENT BRAINSTORM PUBLICATIONS AND PRESENTATIONS

October, 2021

Therapeutic Benefits of MSC-NTF (NurOwn®) Exosomes in Acute Lung Injury Models

Presented at the 2021 NYSCF Conference
October, 2021

CSF biomarker correlations with primary outcome in NurOwn Phase 3 clinical trial

Presented at the 2021 Annual NEALS Meeting
January, 2021

MSC-NTF (NurOwn®) exosomes: a novel therapeutic modality in the mouse LPS-induced ARDS model

Published in Stem Cell Research & Therapy
August, 2020

Effects of MSC-NTF cells on T and B regulatory cell function in ALS

Published in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
November, 2019

NurOwn, phase 2, randomized, clinical trial in patients with ALS

Published in Neurology
May, 2019

Phase 2 Open-Label, Multicenter Study of Repeated Intrathecal Administration of Autologous MSC-NTF cells in Progressive Multiple Sclerosis

Presented at the 2019 Annual CMSC Meeting
BrainStorm’s MSC-NTF cell therapy is investigational and not FDA approved.
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