Promising New Data Shows Cellular Therapy Treatment from NeuroGenesis Significantly Improves Lifespan for ALS Patients

NeuroGenesis reveals positive survival outcomes in patients with ALS treated with “NG01”, a novel cell therapy in a new publication.

ROCHESTER, NY, UNITED STATES, July 8, 2025 /EINPresswire.com/ -- A groundbreaking study published in the Journal of Neurology & Neurosurgery reveals promising long-term survival outcomes in patients with Amyotrophic Lateral Sclerosis (ALS) treated with “NG01”, an innovative autologous stem cell therapy. The research was led by Professor Dimitrios Karussis, Head, MS Centre and Unit of Neuroimmunology and Cell Therapies and the Department of Neurology at Hadassah Medical Center, Jerusalem, Israel.

The study is the most extensive multi-center study of its kind, demonstrating significantly improved survival rates (as compared to the expected rates observed in various epidemiological studies) in patients treated with NG01.

ALS is a progressive neurodegenerative disorder that affects the nervous system, leading to the degeneration of motor neurons—critical cells responsible for controlling voluntary movements such as walking, speaking, and breathing. Researchers at Hadassah Medical Center have developed advanced therapies that target this degeneration by secreting high concentrations of remyelinating and neurotrophic factors directly into the central nervous system.

The NG01 therapy, tested through long-term open-label and placebo-controlled clinical trials in various neurodegenerative diseases, and compassionate use treatments, induces neuro-regeneration and remyelination and repair, which may lead to amelioration of the neurodegeneration that is caused by ALS.

Significant Long-Term Findings
The study analyzed data from three clinical trials conducted over 15 years. The ALS-NG01 trial involved 20 ALS patients. Patients treated with NG01 achieved a median survival of 7.2 years, with 45% (9 out of 20) surviving beyond 10 years post-diagnosis, and one patient still alive after 12 years. These outcomes are highly exceptional when compared to the typical prognosis which often limits survival to just 2–5 years.

Notably, the mean monthly progression rate of the ALS Functional Rating Scale (ALSFRS) prior to NG01 treatment was -1.05 ± 1.63, a rate considered high and associated with poor survival outcomes. Despite this high disease-progression rate at baseline, the NG01 trial achieved encouraging results, offering hope that even patients with rapidly progressing ALS may benefit from such treatment. These findings represent a key step forward, fueling optimism for the development of therapeutic strategies that can not only slow disease progression but also extend survival and improve quality of life for ALS patients.
Previous data on ALS patient survival under currently accepted treatments indicate a median survival of approximately 2.7 years. Only 20% of patients survive beyond five years, and just 10% reach the 10-year mark. The findings of this study suggest that the NG01 platform may have the potential to extend survival compared to conventional treatments.

Additional Insights:
• Extended Survival: Nearly half of the patients treated with NG01 survived beyond a decade, with one patient reaching 12 years survival, post-diagnosis.
• Safety Profile: No unexpected adverse events were observed, underscoring long-term safety.
• Prognostic Insights: Patients with higher baseline ALSFRS-R scores and better Forced Vital Capacity at inclusion showed improved outcomes, highlighting the importance of patient selection in future trials.

"This study provides compelling indications that NG01 therapies can extend survival in ALS patients, even those with traditionally poor prognostic indicators," said Professor Karussis. "Our findings pave the way for larger clinical trials to validate these results and refine treatment protocols."

About the Study
This study is one of the longest observational studies in ALS patients, evaluating the survival rates following cellular therapy. It examined 40 ALS patients treated with intrathecal cell treatments across three clinical trials, utilizing single and repeated injections. The findings underscore the potential of the NG01 platform to address the unmet therapeutic needs of ALS patients.

Bringing Treatments to Patients
“For too long an ALS diagnosis meant limited time and hope,” said Tal Gilat, CEO. “This data shows we can change that. NeuroGenesis is working to turn ALS from a terminal disease to a treatable condition—giving patients the time they deserve."

NeuroGenesis is a privately held, clinical-stage company leveraging the NG01 cellular therapy platform. 100+ progressive MS and ALS patients have been treated with NG01 in clinical trials and compassionate use treatments. NeuroGenesis will begin their Phase 2b clinical trial for Progressive MS which will begin in 2025 led by Principal Investigator Dr. Flavia Nelson, Professor of Clinical Neurology and Director of the National MS Center of Excellence at the University of Miami. NeuroGenesis is working on the protocol for an ALS clinical trial.

Scott Walker
NeuroGenesis
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