Are you looking to explore the next big breakthrough in stem cell therapy? Look no further than NurOwn™, an advanced technology that has already shown potential for providing relief to those suffering from chronic neurological conditions. With its ability to stimulate nerve cells, non-invasively inject mesenchymal stem cells (MSCs) into the central nervous system, and repair damage caused by damaged neurons, it is a welcomed development. It can even provide symptom amelioration as well as improved motor functions! Read on to learn more about this revolutionary stem cell therapy and why it’s gaining traction among medical professionals – and patients alike!
Neurotrophic Factor (NTF) Mesenchymal Stem Cells (MSCs)
The NurOwn® Product MSC is a very legitimate product. It is the mesenchymal stem cell from Brainstorm Cell Therapeutics, a publicly traded company in the United States.
How does the process with NurOwn™ work?
If you were a participant in this study, this is how it would work.
- Bone marrow is harvested because that’s where MSCs live. They might use bone marrow from the pelvic bone.
- They would numb you up and might give you some light sedation.
- They will then use a device to aspirate bone marrow.
- Then, the bone marrow is expanded and cryopreserved.
- Eventually, it’s sent to a central processing facility, where the cells are then thawed and induced to differentiate.
The cells are then transported back to the treatment location, where they are administered directly into the spinal fluid.
MSC-NTF for Primary or Secondary Progressive Multiple Sclerosis (MS)
It’s noteworthy to mention the MSC-NTF clinical trial for multiple sclerosis. This was presented at a European Congress. This involved giving MSC-NTF cells to patients with primary or secondary progressive MS. The goal was to find out if it is safe and how well it works. We also looked at how quickly people could walk 25 feet and do other tests.
The bone marrow was aspirated from 20 patients at various local sites with the aspirate sent to the central facility for culture and differentiation. After shipping that product back to the local site, about one hundred to 125 million MSCs were injected into the spinal fluid in the study subjects at weeks 0, 8, and 16. There are 46 matched controls.
Two patient participants withdrew from the study because their bone marrow aspirate failed to grow adequately. But of the 18 participants treated, 16 all received all three treatments and completed the study including follow-up. At week 28, two participants withdrew, one due to a procedure-related inflammation of the covering over the spinal cord and brain is called arachnoiditis.
We wanted to see if the treatment was safe. Most people said they had headaches or back pain from the treatment. Nobody died from the treatment. And the treatment did not make MS worse for anyone. In fact, people who got the treatment walked better, had an easier time using their hands, and could see better than people who did not get the treatment.
Alongside the successful trial results, a positive change in markers of both neuroprotection and inflammation was identified; showing evidence that this potential treatment could offer much-needed relief to those suffering from MS.
NurOwn™ for Amyotrophic Lateral Sclerosis ALS
How about the ALS study?
Brainstorm Cell Therapeutics has done groundbreaking work in researching potential treatments for ALS. After completing a successful Phase Three trial, they took it to the next level by allowing subjects to continue treatment through an extension trial – truly pushing boundaries and showing dedication towards breakthroughs.
This revolutionary trial was announced in November 2020, with dynamic results that were simply stunning. Those who participated and received NurOwn™ had about a 35% slowing of the expected rate decline measured by the ALS Functional Rating Scale Score revised – an incredible result!
The placebo group had a slowing as well. So there was a placebo effect, and this is very common. However, their slowing was only about 15% compared to the 35.5% in the treatment group with ALS. This difference between 15 and 35 was considered to be both statistically and clinically significant.
This was the basis for going on to the phase three trial.
When subjects were enrolled in the phase three trial, it’s important to know the investigators enrolled subjects who were more severely affected at the time of treatment; their ALS was worse. It is significant because when the phase three trial was completed, the investigators and the statisticians still found that the expected rate of decline in subjects treated with NurOwn who actually had ALS still had a slowing of about 35.5%.
The trial went well and there were some things that we could measure to show that the treatment was working as it was supposed to. Things like the amount of a certain kind of protein in the spinal fluid and how active the cells were in the brain. The treatment was supposed to help new nerves grow, reduce inflammation, and slow down cell death.
However, in the phase three trial, there was a very big jump in the response of the placebo group up to about 29%. Because the difference between 29% and 35%, is much smaller, it was not possible on a statistical basis to say that the treatment group benefitted more than the placebo group.
Although this may not be the outcome we expected, there is always an opportunity to learn more.
Biologics License
By rigorously reexamining their data, researchers discovered that by comparing those in the early stages or with mild ALS to their placebos, a remarkable difference was uncovered- 35% of experimental group subjects enjoyed improved rates of stability while only 15% amongst the placebo were accounted for.
It’s very clear that NurOwn™ is actually quite effective. But like many other conditions, the most effective intervention is when the problem is caught and treated early.
With that information in hand, not only was Brainstorm Cell Therapeutics allowed to continue with an extension trial, but ultimately they decided to submit for a “Biologics License” based on that smaller subset of the phase 3 trial. We were hoping that the FDA would approve the treatment for more mildly affected ALS patients.
Despite initial setbacks, we are actively continuing the pursuit of a much-needed biologics license. We remain hopeful that this vital accreditation will be secured upon appeal, and our ambition to provide cutting-edge treatments remains undeterred.
South Korean Stem Cell Situation
Evidence for the therapeutic potential of NurOwn™ has been strengthened by the success of a similar stem cell product in South Korea. The latter, approved by their FDA equivalent, further demonstrates that this type of treatment can be effective and impactful.
The treatment is not available in the United States, but it is available in South Korea. The treatment was approved in South Korea after a phase-two trial. In the United States, we are starting to see treatments being approved for conditions like ALS even though all the phases of clinical trials have not been completed yet. We recently saw that with the Amyx Pharmaceuticals product, RELYVRIO, for example.
In South Korea, a product similar to NurOWn™ is showing promising results with decelerating rates of functional decline for those suffering from ALS – a result that mirrors NurOWn™’s success in other parts of the world.
Investigational treatments are underway, utilizing autologous mesenchymal stem cells to tackle the devastating effects of ALS, MS, Parkinson’s disease, and Alzheimer’s. By harnessing this cutting-edge technology we could one day soon see tremendous progress in providing relief for those suffering from these illnesses.
We hope this blog post has opened your eyes to the fascinating and potentially life-changing breakthroughs available with NurOwn™ as a stem cell therapy for chronic neurological conditions. The research into NTF delivery of mesenchymal stem cells is certainly promising.
Overall, NurOwn™ offers an incredible promise of improved quality of life for those living with amyotrophic lateral sclerosis and other chronic neurological conditions. It is clear that stem cell therapy holds immense potential for providing healing, recovery and possibly even cure in such cases – we simply couldn’t be any more excited! If you are intrigued by what you have learned here today and would like to explore your options further, why not schedule a discovery call with one of our qualified personnel? With our help, you can begin navigating toward improved health and well-being now!
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DISCLAIMER: The information in this email is not intended nor implied to be a substitute for professional medical advice, diagnosis, or treatment. All content is for general informational purposes only and does not replace a consultation with your own doctor/health professional.