Neuralstem Cell Therapy for ALS

I haven’t written in a long time but needed to share that little piece of news… that is bringing great joy to my heart. I am impatiently waiting for the results… I hope it went well:

Product status:
U.S.: FDA-approved NSI-566 Phase II trials commenced in September 2013, and concluded final surgeries in July 2014. Phase II concludes after six-month observation period.
Mexico City: NSI-566 Phase I / II trial expected to commence in 2014
Mechanism of Action: Rebuilding neural circuitry
Route of Administration: Direct injections into the spinal cord

Neuralstem is seeking to treat the symptoms of ALS via transplantation of its NSI-566 human spinal cord stem cells (HSSCs) directly into the gray matter of the patient’s spinal cord. In ALS, motor neurons die, leading to paralysis. In preclinical animal work, Neuralstem cells both made synaptic contact with the host motor neurons and expressed neurotrophic growth factors, which are protective of cells. View published papers here: 1, 2, 3.

Neuralstem initiated the first FDA-approved stem cell trial for ALS in January 2010, at Emory University. This Phase I safety trial, to evaluate the safety of the NSI-566 cells and surgical technique, was designed to enroll up to 18 patients. The Principal Investigator is Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute, Director of Research of the ALS Clinic at the University of Michigan Health System, and President of the American Neurological Association. The Site Investigator is Jonathan Glass, MD, Professor of Neurology, Emory School of Medicine and Director of the Emory ALS Center. The trial was awarded an Orphan Drug Designation by the FDA in February 2011.

In humans, Neuralstem expects that the transplanted cells will:

GRAFT permanently into the region where they were transplanted
REBUILD circuitry with the patient motor neurons
PROTECT patient neurons from further ravages of the disease

In a review of the safety data from the initial nine patients, Neuralstem cells were deemed to be safe, with no adverse reactions reported believed to be related to cells or surgical technique.
Neuralstem ALS Trials

Neuralstem concluded final surgeries in the company’s NSI-566/ALS Phase II trials in July 2014. This phase of the study will conclude after a six-month observation period. The Phase II trials were approved by the FDA to commence in April 2013, upon conclusion of the Phase I FDA-approved trial to test the safety of the neural stem cells and transplantation surgery in patients with ALS in February 2013. The National Institutes of Health and ALSA committed to generous grants in funding for the Phase II phase of the study.

The NSI-566/ALS Phase II dose escalation and safety trials commenced in September 2013, and expanded to three centers: Emory University Hospital in Atlanta, Georgia, site of Phase I; ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, and Massachusetts General Hospital in Boston. The trials were designed to treat up to 15 patients, in five different dosing cohorts. The final cohort have received a total of 16 million NSI-566 neural stem cells, through 40 surgical injections of 400,000 cells per injection. (Phase I maximum was 15 injections of 100,000 cells each.) All of the patients were ambulatory and resided within close geographic proximity to the research center where they participated. The first 12 patients received injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function. The final three patients underwent lumbar transplantation and returned for the cervical treatment during a second surgery.

The Phase I safety trial enrolled 18 patients. The trial began with 12 late- to mid-stage patients who received a series of injections in the L2-L4 lumbar region. The first six patients were all non-ambulatory with permanent paralysis. Of these, the first three patients (Cohort A1) were treated with five unilateral cell injections, while the next three patients (Cohort A2) received ten bilateral injections in the same region. The trial then progressed to patients who were ambulatory. The first three of these (Cohort B) received five unilateral injections. The next three patients (Cohort C) received ten bilateral injections in the same lumbar region.

Neuralstem received approval from the FDA to move into the cervical (upper back) stage of the trial in the fall of 2011. The first of six patients in the cervical cohorts to receive stem cells was treated on November 18, 2011, which marked the first FDA-approved intraspinal surgical transplantation of stem cells into the cervical region. The trial then advanced to the final cervical cohort of three patients. The FDA approved the return of three patients from earlier cohorts to receive cervical transplants, making them the first to receive stem cell transplantation in both the lower and upper parts of their spinal cord. The first of these was treated in June 2012, and received five stem cell injections into the cervical region of the back, for a total of 15 injections, including the ten lower-back injections previously received. The last patient in the Phase I trial was treated in August 2012. The trial was designed as a safety trial to treat 18 patients, and concluded six months after the final surgery.

Mysticism and Science 2

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I just stumbled into this very interesting article and book by Dr. Robert Lanza, the reference in regenerative medicine, about biocentrism, a new notion that is gaining momentum.

Waking Times

A book titled “Biocentrism: How Life and Consciousness Are the Keys to Understanding the Nature of the Universe“ has stirred up the internet, because it contained a notion that life does not end when the body dies, and it can last forever. The author of this publication, scientist Dr. Robert Lanza who was voted the 3rd most important scientist alive by the NY Times, has no doubts that this is possible.

Beyond Time and Space

Lanza is an expert in regenerative medicine and scientific director of Advanced Cell Technology Company. Before, he had been known for his extensive research which dealt with stem cells, he was also famous for several successful experiments on cloning endangered animal species.

But not so long ago, the scientist became involved with physics, quantum mechanics and astrophysics. This explosive mixture has given birth to the new theory of biocentrism, which the professor has been preaching ever since. Biocentrism teaches that life and consciousness are fundamental to the universe. It is consciousness that creates the material universe, not the other way around.

Lanza points to the structure of the universe itself, and that the laws, forces, and constants of the universe appear to be fine-tuned for life, implying intelligence existed prior to matter. He also claims that space and time are not objects or things, but rather tools of our animal understanding. Lanza says that we carry space and time around with us “like turtles with shells.” meaning that when the shell comes off (space and time), we still exist.

The theory implies that death of consciousness simply does not exist. It only exists as a thought because people identify themselves with their body. They believe that the body is going to perish, sooner or later, thinking their consciousness will disappear too. If the body generates consciousness, then consciousness dies when the body dies. But if the body receives consciousness in the same way that a cable box receives satellite signals, then of course consciousness does not end at the death of the physical vehicle. In fact, consciousness exists outside of constraints of time and space. It is able to be anywhere: in the human body and outside of it. In other words, it is non-local in the same sense that quantum objects are non-local.

Lanza also believes that multiple universes can exist simultaneously. In one universe, the body can be dead. And in another it continues to exist, absorbing consciousness which migrated into this universe. This means that a dead person while traveling through the same tunnel ends up not in hell or in heaven, but in a similar world he or she once inhabited, but this time alive. And so on, infinitely. It’s almost like a cosmic Russian doll afterlife effect.

Multiple Worlds

This hope-instilling, but extremely controversial theory by Lanza has many unwitting supporters, not just mere mortals who want to live forever, but also some well-known scientists. These are the physicists and astrophysicists who tend to agree with existence of parallel worlds and who suggest the possibility of multiple universes. Multiverse (multi-universe) is a so-called scientific concept, which they defend. They believe that no physical laws exist which would prohibit the existence of parallel worlds.

The first one was a science fiction writer H.G. Wells who proclaimed in 1895 in his story “The Door in the Wall”. And after 62 years, this idea was developed by Dr. Hugh Everett in his graduate thesis at the Princeton University. It basically posits that at any given moment the universe divides into countless similar instances. And the next moment, these “newborn” universes split in a similar fashion. In some of these worlds you may be present: reading this article in one universe, or watching TV in another.

The triggering factor for these multiplying worlds is our actions, explained Everett. If we make some choices, instantly one universe splits into two with different versions of outcomes.

In the 1980s, Andrei Linde, scientist from the Lebedev’s Institute of physics, developed the theory of multiple universes. He is now a professor at Stanford University. Linde explained: Space consists of many inflating spheres, which give rise to similar spheres, and those, in turn, produce spheres in even greater numbers, and so on to infinity. In the universe, they are spaced apart. They are not aware of each other’s existence. But they represent parts of the same physical universe.

The fact that our universe is not alone is supported by data received from the Planck space telescope. Using the data, scientists have created the most accurate map of the microwave background, the so-called cosmic relic background radiation, which has remained since the inception of our universe. They also found that the universe has a lot of dark recesses represented by some holes and extensive gaps.

Theoretical physicist Laura Mersini-Houghton from the North Carolina University with her colleagues argue: the anomalies of the microwave background exist due to the fact that our universe is influenced by other universes existing nearby. And holes and gaps are a direct result of attacks on us by neighboring universes.

Soul

So, there is abundance of places or other universes where our soul could migrate after death, according to the theory of neo-biocentrism. But does the soul exist? Is there any scientific theory of consciousness that could accommodate such a claim? According to Dr. Stuart Hameroff, a near-death experience happens when the quantum information that inhabits the nervous system leaves the body and dissipates into the universe. Contrary to materialistic accounts of consciousness, Dr. Hameroff offers an alternative explanation of consciousness that can perhaps appeal to both the rational scientific mind and personal intuitions.

Consciousness resides, according to Stuart and British physicist Sir Roger Penrose, in the microtubules of the brain cells, which are the primary sites of quantum processing. Upon death, this information is released from your body, meaning that your consciousness goes with it. They have argued that our experience of consciousness is the result of quantum gravity effects in these microtubules, a theory which they dubbed orchestrated objective reduction (Orch-OR).

Consciousness, or at least proto-consciousness is theorized by them to be a fundamental property of the universe, present even at the first moment of the universe during the Big Bang. “In one such scheme proto-conscious experience is a basic property of physical reality accessible to a quantum process associated with brain activity.”

Our souls are in fact constructed from the very fabric of the universe – and may have existed since the beginning of time. Our brains are just receivers and amplifiers for the proto-consciousness that is intrinsic to the fabric of space-time. So is there really a part of your consciousness that is non-material and will live on after the death of your physical body?

Dr Hameroff told the Science Channel’s Through the Wormhole documentary: “Let’s say the heart stops beating, the blood stops flowing, the microtubules lose their quantum state. The quantum information within the microtubules is not destroyed, it can’t be destroyed, it just distributes and dissipates to the universe at large.” Robert Lanza would add here that not only does it exist in the universe, it exists perhaps in another universe.

If the patient is resuscitated, revived, this quantum information can go back into the microtubules and the patient says “I had a near death experience”‘

He adds: “If they’re not revived, and the patient dies, it’s possible that this quantum information can exist outside the body, perhaps indefinitely, as a soul.”

This account of quantum consciousness explains things like near-death experiences, astral projection, out of body experiences, and even reincarnation without needing to appeal to religious ideology. The energy of your consciousness potentially gets recycled back into a different body at some point, and in the mean time it exists outside of the physical body on some other level of reality, and possibly in another universe.

http://www.zengardner.com/quantum-theory-proves-consciousness-moves-another-universe-death/

 

 

Mysticism and Science

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“There is a central order to the universe, an order that can be directly apprehended by the soul in mystical union.”

–Albert Einstein

“Have you often found yourself moved by a fine speech or piece of poetry? Do you sometimes feel a spiritual connection to other people that can’t be explained in words? Do you think mystical experiences are just wishful thinking, or real?

These questions are from the third and final subscale of self-transcendence, which Cloninger call “spiritual acceptance versus rational materialism”.

Individuals who score high for mysticism are fascinated by things that can’t be explained by science. They see a loaf of breed that resembles Jesus or parking space that opens up just in the nick of time as evidence of a higher power. Often they claim to have a “sixth sense,” or extrasensory perception. They believe in miracles.

Low scorers on this subscale are more materialistic and objective. The see an unusual loaf of bread or an unexpected parking opportunity as nothing more than coincidence. They don’t believe in things that can’t be explained scientifically.”

Taken from the book The God Gene by Dean Hamer, a must read, for both scorers.

Friedrich Nietzsche

nietzsche

To understand how a monster thinks, one must become one himself – watch out however not to fall in love in the process, the life of a monster may have appeals you never suspected existed.

“Whoever fights monsters should see to it that in the process he does not become a monster. And if you gaze long enough into an abyss, the abyss will gaze back into you.”

Friedrich Nietzsche

 

To read more about this exceptional philosopher, click here: http://plato.stanford.edu/entries/nietzsche/#Lif184190

Induced Pluripotent Stem Cells from Bone Marrow-Derived, Peripheral Blood-Derived Hematopoietic Cells and Cord Blood.

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As mentioned in a previous article—Public and Private Cord Blood Banking: United We Stand!—umbilical cord blood obtained from the umbilical cord and placenta is a rich source of MSPC’s and HSPC’s; the latter can be used for transplantation to treat a range of malignant, genetic, metabolic, and immune disorders. In fact, it was shown that cord blood HSPC’s are more proliferative and have a greater chance of matching family members than stem cells from bone marrow. Additionally, cord blood is not only widely available and easily accessible—collection is relatively non-invasive, safe and painless—but its derived HSPC’s can even be safely infused when they are an incomplete match for the recipient due to their immunologically naïve quality.

Given the importance of bone marrow and cord blood transplants, the growing numbers of patients requiring them, their growing availability and the quality of those units, one can only wonder if those cells wouldn’t make better candidates for not only inducing pluripotency but also in making pluripotent cells of better quality for clinical use once the difficulties discussed in the previous article are overcome. Indeed, nuclear and mitochondrial mutations in adult stem cells and differentiated somatic lineages appear to accumulate over a lifetime and have been suggested to contribute to aging and cancer formation.

After many efforts, it was found that mature bone marrow derived hematopoietic cells were indeed reprogrammable into pluripotent cells, however it was more difficult than in fibroblast cells. Indeed, they initially required previous transdifferentiation into adherent macrophage-like cells through retroviral overexpression of the myeloid transcription factor CCAAT/enhancer-binding protein-beta. It was later found that less mature bone marrow derived hematopoietic cells were more easily reprogrammable into pluripotent cells.

Peripheral blood derived hematopoietic cells were found to be very bad candidates for inducing pluripotency as they are predominantly nonadherent and slow-cycling. Indeed, researchers were initially simply unable to induce pluripotency unless using G-CSF-mobilization of HSCs, however that was expensive, time consuming and was found to potentially have detrimental effects on individual donors. After many efforts, and without prior stem cell mobilization, several groups were able to induce pluripotency of different mouse and human blood lineages. However, the observed reprogramming efficiencies were typically lower than for fibroblasts.

It was found that cord blood endothelial cells were superior cells for the induction of pluripotent stem cells based on the criteria that they were adherent and actively dividing cells. Furthermore, Giorgetti et al. demonstrated that even frozen cord blood could be used to generate iPSCs with overexpression of OCT4 and SOX2 only. These cells have biological superiority and, thus, could be made available quite rapidly for thousands of patients. For example, children born with cardiac malformations could benefit from CB-iPSC-derived tissue transplants.

In conclusion, it was found that hematopoietic cells from cord blood represent an easily accessible cell source for the derivation of clinically useful iPSCs. Indeed, allogeneic and autologous cord blood from public and commercial CB banking may provide a superior and almost unlimited juvenescent cell source for the production of clinically useful iPSCs.

Y.S.H.

New Novel Under Review

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This is the first picture of me as a published writer (to become a professional writer was a big event for me and one of the most horrible experience in my life! Love writing but hate the business side of it). My new novel is currently under review and soon it will be either put on hold or published. It is about genetic manipulation, conspiracy theories, parascience, psychical abilities and research, secret military programs, etc. Most of it is actually based on real facts but the story itself is of course completely fictional. No matter the result it will  be my last novel as I have decided to dedicate my writing time to research papers and scientific articles.

So to all of my readers, I want to say thank you for having supported me and for having enjoyed my books over the years 🙂

Cheers!