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NeoStem’s (AMEX: NBS) VSEL™ Technology, Ending the search of the perfect Repair Cell

 

 

VSELs may represent the “Holy Grail” of stem cell therapy, a natural “pluripotent”.  

In an unexpected setback to efforts to harness a promising new type of stem cell to treat diseases, researchers reported on 5/13/11; that tissues made from those stem cells might be rejected by a patient’s immune system – even though the tissues would be derived from that very same patient.

The research involved so-called induced pluripotent stem cells, or iPS cells, which can be made from skin cells and which appear to have the characteristics of embryonic stem cells.  The initial creation of human iPS cells in 2007 electrified scientists because the cells seemed to have 2 big advantages over embryonic stem cells. They were not controversial, because their creation did not entail the destruction of human embryos. And since the stem cells could be made from a particular patient’s skin cells, they could be used to make tissues that presumably would not be rejected by that patient’s immune system. (NY Times, A Pollack)

However, it had been ASSUMED that these autologous cells should be immune-tolerated by the recipient from whom the iPSCs are derived; their immunogenicity HAD not been vigorously examined.

In cell biology, pluripotent refers to a stem cell that has the potential to differentiate into any of the three germ layers: endoderm (interior stomach lining, gastrointestinal tract, the lungs), mesoderm (muscle, bone, blood, urogenital), or ectoderm (epidermal tissues and nervous system).

NeoStem (NYSE Amex: NBS) is pioneering bone marrow-derived very small embryonic-like (VSEL) pluripotent stem cells which represent a recruit-able pool that appears to play an important role in organ repair after injury. The study of stem cells and cord blood is on fast tracks and is proving to already lead to new discoveries.

NBS’ VSELs or very small embryonic like stem cells have many physical characteristics typically found in embryonic stem cells, including the ability to differentiate into specialized cells and tissue throughout the body. The significance of VSELTM technology is that each person has a population of very primitive embryonic-like stem cells that can be harvested for potential therapeutic use. This is possible because very small embryonic like stem cells are also released into the peripheral blood by using FDA approved drugs, which function as a mobilizing agent.

It has been demonstrated in animal models that VSELs once administered converge or “home into” where they are needed. VSELs then appear to interact with the localized trauma environment which could be “ischemic” (compromised blood flow) or “hypoxic” (oxygen deprived) in the case of a stroke or heart attack. 

  • VSELs or primitive pluripotent stem cells can be used to regenerate a heart (myocyte) cell or bone (osteoblast) tissues in the body;
  • VSELs are activated and migrate in the presence tissue injury from the bone marrow to the peripheral blood accessing tissues throughout the body in response to (tissue) damage.

VSELs given their ability to differentiate into all 3 germ layers give rise to all the body’s tissues originating from our own blood adult stem cell … and are therefore autologous … unlike a manipulated cell type such as induced pluripotent (iPS) stem cells which suffer chances of rejection.

  • VSELs, like most stem cells, possess the same paracrine (secretion released by the cell into surrounding cell tissue or adjacent cells) mechanism of action (increased blood vessel formation and reduced inflammation) but with tissue targeting (homing) characteristics and the ability to not only interact with the local bodily environment but to differentiate as needed and even act as a repair or replacement cell.

These VSEL cells are NATURAL and do NOT carry the RISK of abnormal activation of genes which HAS BEEN seen with iPS cells.

  • VSELs are an emerging autologous adult pluripotent stem cell population with great potential regenerative capabilities for the treatment of cardiovascular (acute and chronic heart disease), bone (osteoporosis, arthritis), blood, skin (wounds), retinal (NASDAQ:AMD), lung diseases, acute radiation syndrome and potential biomarkers of aging.

VSELs safety arises from the fact that unselected VSELs have been administered as part of bone marrow transplants for over the past 40 years.

  • VSELs are natural thus autologous because VSELs are originate from our body and can be administered (back to us) once isolated without concerns of rejection contrary to induced pluripotent stem cells.  

The Bottom Line:  VSELs show tremendous potential in a wide range of indications from non-healing traumatic wounds, bone repair and Osteoporosis, AMD to Acute Radiation Syndrome. VSELs are still in the pre-clinical stages of development and NBS is planning to enter trials in the later half of this year (2011)… There is even scientific data that suggests VSELs may be a valid marker of aging. AMEX:NBS with its Progenitor Cell therapy division is working with some of the worlds leading scientists to unlock the potential of its VSELs platform. NBS’s VSEL™ technology is proprietary with exclusive worldwide license from the University of Louisville.  AMEX: NBS is currently harvesting and cryo-preserving these VSELs from individual patients, setting the stage for their use in personalized regenerative medicine. These VSELs are: Isolated from a patient’s own bone marrow, peripheral blood, or cord blood; demonstrate pluripotency and somatic imprinting; small volume of these very small embryonic-like stem cells should provide adequate doses; expandable if necessary; are easily obtained and stored in cryopreservation to preserve in advance and bank for future use; and finally, VSEL™ stem cells maintain embryonic characteristics yet are classified as adult. So, expanding their definitions:

  • VSELs can be mobilized from bone marrow in humans and are normally at low levels in blood.  VSELs have been shown to mobilize into peripheral blood of patients immediately following acute myocardial infarction (Wojakowski et al. 2009), and stroke (Paczkowska et al. 2009; Kucia et al. 2006);
  • Recently, research (Drukala et al. 2011) has shown that skin burn injuries in humans are associated with significant mobilization of VSELs to peripheral blood to be recruited to the site of wound healing;
  • Mobilization  of VSELs seem to be part of a protective reaction of the body to repair heart, brain, lung and other tissues following injury; animal studies have shown VSELs to effectively repair cardiac tissue in an animal model of acute MI (Dawn et al. 2008; Zuba-Surma et al. 2010); 
  • VSELs may also be of use in treating retinal injuries (Machalińska et al., 2010; Liu et al. 2009) and rescuing the immune system after radiation exposure (Ratajczak et al. 2011);
  • Recent work has also shown that human VSELs can form bone (osteogenic) and blood vessel cells (angiogenic);
  • VSELs can be collected and isolated from our bodies even as adults: NBS has shown that human VSELs can be mobilized into peripheral blood of adults by G-CSF stimulation (Rodgerson and Harris, 2011; Medicetty et al. 2009);
  • VSELs are easily isolated from an apheresed (a minimal invasive and safe procedure) sample (200-300 ml) of an individual and purified allowing selection of the targeted VSELs population and then used to treat that same individual (autologous therapy). This method has been deemed very desirable versus the more invasive procedures of collecting bone marrow aspirates;
  • For the record, a patient/client can  select a collection date, and for 2 days prior to collection receive a stem cell mobilizing agent (through injection), that increases the number of stem cells in the circulating blood. The collection procedure is 3-4 hours, and is similar to donating platelets or partially similar to donating blood. Blood is circulated through a highly specialized machine that collects cells in an extremely safe and sterile manner. Upon completion, the product is packed and sent for processing and storage at a licensed laboratory facility where it remains available for use at any time.  Normal activities can be resumed almost immediately following the collection procedure.

The Catholic Church had endorsed (5/28/10) adult stem cell research through AMEX: NBS including a $1M investment and pledge to educate priests, schools and hospitals on its benefits. The church is opposed to embryonic stem cell research because it involves the destruction of embryos, but it supports the use of adult stem cells, which are found in the bodies of all humans.