Personalized Stem Cells

New autologous neural stem cells with the potential to realize the treatment promise of stem cell therapy in CNS indications.

NWL’s new neural stem cells (NWL-NSCs) are neural stem-like cells that are created from somatic cells (i.e. directly from the patient’s skin or blood cells) through NWL´s completely new and powerful way of “reprogramming” without any genetic engineering. NWL-NSCs thus fill the huge market demand for autologous neural stem cells and have the potential to – for the first time – realize the treatment promise of stem cell therapy in CNS-related indications.

Target indications include the majority of neurodegenerative diseases (e.g. MS, Alzheimer’s, Parkinson’s), ischemia, injury and trauma of the CNS (e.g. stroke, traumatic brain injury, spinal cord injury). Most neurodegenerative diseases and neurotrauma are currently untreatable and represent almost half of all healthcare costs. NWL-NSCs is a disruptive platform technology that could significantly lower these healthcare costs by providing a safe and effective stem cell therapeutic to patients, resulting in an enormous market potential.

NWL-NCSs are reprogrammed from the patient’s own somatic cells in 1-2 weeks and can be grown to nearly 1 billion autologous NSCs within six weeks; these are then injected or implanted into the patient.

Other stem cells under development are cardiac stem-like cells (NWL-CSCs) for cardiac (heart) regeneration, and pancreatic stem-like cells (NWL-PSCs) as a source of autologous islet beta-cells for diabetes.

PRODUCT INDICATIONS STAGE
Neural Stem-like Cells Spinal cord injury
Traumatic brain injury
Parkinson’s disease
Multiple Sclerosis (MS)
Alzheimer’s disease
Stroke
Under Development by:
Cardiac Stem-like Cells Cardiac regeneration Pre-Clinical
Hematopoietic Stem-Like Cells HIV/AIDS, Leukemia, Blood Disorders Pre-Clinical
Pancreatic Stem-like Cells Diabetes
Pancreatic regeneration
Development

NWL-NSCs are:

Ethical:

NWL-NSCs are ethical and unlimited in number.
Competition: Fetal and embryonic-derived neural stem cells are debated and limited.

Autologous (i.e. reprogrammed from the patient’s own somatic cells):

NWL-NSCs allow for endogenous grafting and no immunorejection.
Competition: Fetal and embryonic-/iPS cell-derived neural stem cells rarely graft permanently and require the use of immunosuppressant drugs. (Note: Embryonic- and iPS cell-derived neural stem cells could also be made autologous, but this takes ~ 6 months (vs. 4-6 weeks for NWL-NSCs), are less potent (vs. NWL-NSCs), and are prohibitively expensive due to the tumor and teratoma risk factors of these cells).

Potent:

NWL-NSCs are significantly more potent than fetal as well as embryonic- and iPS cell-derived neural stem cells due to: (i) higher purity, (ii) lower passage number, (iii) greater neuronal differentiation potential, and (iv) being autologous.

Safe:

NWL-NSCs have a high safety margin.
Competition: Embryonic- and iPS cell-derived neural stem cells have a high risk of tumors and teratomas.

Patentable:

NWL-NSC composition-of-matter is patent-pending as these stem cells have unique characteristics and are created by a proprietary completely novel process.

The study of salamanders and the Regeneration Matrix™ at NWL have revealed that during regenerative regrowth, surrounding somatic cells dedifferentiate to stem-like cells that then take the role of the “workhorses” of rebuilding tissue. This led to the investigation of the mechanisms by which somatic cells could be converted to such “stem-like cells”, and after several years of research a method emerged. These pioneering scientific insights are now applied at NWL to the creation of different stem-like cells from a patient’s own somatic cells (ex. directly from skin or blood cells).

NWL’s neural stem-like cells (NWL-NSCs) have achieved potent regenerative effects in vitro and in vivo. NWL-NSCs regenerate the CNS significantly better (p<0.001) than fetal neural stem cells with no observed side-effects, and with no formation of tumors or teratomas.

NWL is completing the preclinical work package on NWL-NSCs. As an autologous cell therapy, NWL-NSCs will face an easier and faster path to market approval, allowing potential launch in 3 years.

Stem cells currently provide the most promising venue to treat neurodegenerative diseases1. However, not all stem cells are the same; for example:

(i) Embryonic and other pluripotent stem cells (ex. iPS cells) can turn into any type of cell which makes them very difficult to control and generally results in the wrong type of cell to grow in the wrong place – this results in teratomas (a mass of cells containing different types of tissues) and tumors. Even when their differentiation can be controlled, pluripotent stem cells will more likely grow a new competing tissue within the existing tissue rather than integrate into the existing damaged tissue.

(ii) Multipotent stem cells (a.k.a. somatic stem cells) are lineage-restricted stem cells that regenerate and grow existing tissues of their specific lineage (for example, neural stem cells regenerate and grow the nervous system, skin stem cells regenerate and grow skin, and hematopoietic stem cells regenerate blood by providing blood cells)). This unique feature of somatic stem cells is sometimes confused with the pluripotent stem cells (in part (i) above) that do not possess this feature. However, the unique feature of somatic stem cells requires that the right type of somatic stem cells is used for the particular tissue to be treated (for example, a hematopoietic or mesenchymal stem cell will have very limited regenerative abilities if implanted into the CNS, since neural stem cells are the stem cells that have evolved for this particular purpose). There is a general lack of awareness of this feature / requirement of somatic stem cells resulting in confusion whereby ex. mesenchymal stem cells have been implanted into numerous unrelated tissues of the body that has resulted in – as expected – limited to no beneficial effects.

(iii) For any stem cell to permanently graft into the patient’s tissue, the stem cell has to be autologous (the patient’s own). The only exception to this is hematopoietic stem cell grafts (bone marrow transplants) due to the changes in the immune and other systems in the body caused by these specific somatic stem cells. However, this unique ability of hematopoietic stem cells has caused confusion about the abilities of other somatic stem cells – for example, there is a perception that other types of allogeneic (another person’s) somatic stem cells will adequately graft into a patient if the patient is immunosuppressed or if the implanted somatic stem cells has a very low immune signature (as is, for example, in the case with mesenchymal stem cells). The reality is that although these strategies allow these somatic stem cells to survive in the patient’s body for a long time without being detected by the patient’s immune system, there is another unknown biological component that prevents these cells from grafting properly, thus severely limiting their regenerative and growth enabling properties.

Thus in order to gain the greatest benefit from a stem cell therapy, the stem cell should be an autologous somatic stem cell of the right type. For neurodegenerative diseases, the stem cell of choice is an autologous neural stem cell2.


1 Achanta et al., 2010; Andres et al., 2011; Bergström and Forsberg-Nilsson, 2012; Chen and Blurton-Jones, 2012; Crocker et al., 2011; Curt, 2012; Daadi et al., 2010; Daadi et al., 2012; De Feo et al., 2012; Glass et al., 2012; Göritz and Frisén, 2012; Hefferan et al., 2012; Huang and Franklin, 2011; Jensen et al., 2011; Kakinohana et al., 2012; Kuwabara and Asashima, 2012; Lee et al., 2010; Lee et al., 2012l Lukovic et al., 2012; Lu et al., 2012; Martinez et al., 2012; Nakayama et al., 2010; Pritchard et al., 2010; Ruff and Fehlings, 2010; Salazar et al., 2010; Shihabuddin and Cheng, 2011; Smith et al., 2012; Tsuji et al., 2011; Xu et al., 2009; Xu et al., 2011; Xu et al., 2010; Zhang et al., 2011.
2 Achilleos and Trainor, 2012; Barkho and Zhao, 2011; Capetian et al., 2011; Decimo et al., 2012; Fainstein et al., 2012; Gonzales-Perez et al., 2010; Grabel, 2012; Kazanis, 2012; Lee et al., 2010; Martino et al., 2011; Okano, 2010.

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New autologous neural stem cells with the potential to realize the treatment promise of stem cell therapy in CNS indications....

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