| During the past ten years since the sequencing of | | | | Following isolation of the stem cells, further |
| the human genome, personalized medicine where | | | | processing can be performed. Processing can be |
| therapeutics are developed for the individual from the | | | | minimal, and the "minimally processed" cells used for |
| person's genetic information has shown promise for | | | | medical procedures, or the stem cells can be |
| delivering more efficacy and fewer side-effects. | | | | processed in a number of ways such that the stem |
| However, despite many scientific gains in genomics | | | | cells now become classified as "biologics" requiring |
| during the past decade, human health, according to | | | | FDA approval for their use in patients. As an |
| Dr. Francis Collins and Dr. Craig Venter, leaders of the | | | | example, stem cells can be processed in order to |
| genomic revolution, has only marginally benefited | | | | cause the cells to differentiate. When stem cells |
| from the sequencing of the human genome (Nature, | | | | differentiate, the stem cell becomes modified into a |
| 464, 649-650, 1 April 2010). The field of | | | | more mature cell and may transform into, for |
| pharmacogenomics is still in its early stages. Genetic | | | | example, a cardiac cell. In this case, the differentiated |
| variations within individuals may exist in the millions, | | | | cardiac cell can now be implanted into a patient for |
| and identifying the variations may require many | | | | treatment of heart conditions. Because the patient's |
| years, or decades. In addition, how an individual | | | | stem cell was differentiated into a heart cell and then |
| responds to a medication will probably not be | | | | implanted into the patient, instead of implanting the |
| determined by just one gene but rather by many | | | | stem cell itself, FDA will consider the differentiated |
| genes interacting with one another. Biology does not | | | | heart cell a biologic and require approval. |
| act in a reductionist manner, rather biological | | | | While processing the stem cells into FDA approved |
| phenomenon, including therapeutics, act as a system. | | | | biologics may prove useful for many indications, many |
| Examining this complicated genetic map is expensive | | | | studies have demonstrated the remarkable efficacy |
| and time-consuming. As a result, pharmacogenomics | | | | of using minimally processed stem cells in medical |
| as a routine part of medicine is likely decades away. | | | | procedures. Although many challenges face the new |
| Unlike the relatively slow progress being made in the | | | | field of stem cell therapeutics, one of the key |
| development of drugs through a process of | | | | features of stem cells learned during the 1990s is |
| understanding an individual's genome, and then | | | | their ability to heal tissue by releasing a multitude of |
| developing a targeted drug based on the individual's | | | | molecules into the damaged tissue. The release of |
| genetic information, known as pharmacogenomics | | | | these molecules into the damaged tissue is an |
| (PGx), this means for developing drugs for | | | | important, if not primary, means for many indications |
| personalized medicine has yet to realize the | | | | in the stem cell's capacity to promote healing. Thus, |
| therapeutic potential that autologous stem cell | | | | the stem cell can be considered a mobile factory for |
| procedures have realized. | | | | the production of the multitude of molecules, the |
| Personalized regenerative medicine for many | | | | multitude of healing molecules (Singec, I. 2008 Stem |
| indications can now be realized through autologous | | | | Cells, 1: 313-328). |
| stem cell therapeutics. Harvesting potent stem cells is | | | | Using the stem cells to generate a multitude of |
| easily accomplished by lipo-aspirating fat from the | | | | molecules is a "systems approach" to developing a |
| patient, and then separating mesenchymal stem cells | | | | therapeutic. As discussed in the aforementioned |
| from the adipose tissue. The mesenchymal stem cells | | | | section, biological processes do not act alone; single |
| can be further processed for a number of | | | | molecules are a component of a larger process. If |
| procedures and have been shown to be very potent | | | | one studies the healing process of wounded skin for |
| therapeutic agents for many indications, including | | | | example, there is a cascade of events involved |
| cardiac, CNS, immune system, joint, and plastic | | | | where many molecules act within a system to |
| reconstructive procedures. Further, because | | | | promote healing of the wound. Using just one of the |
| mesenchymal stem cells avoid allogenic rejection | | | | molecules to promote healing of the wound may |
| (Ryan, J. Inflammation 2005, 2:8), these cells have the | | | | have some utility, but the efficacy will not compare |
| potential of being used more widely, such as recent | | | | to using the full complement of molecules. In a 2010 |
| treatments at several children's hospitals in the US, | | | | study that included Dr. Collins as an author, a scan of |
| where allogenic stem cells have been used to | | | | human DNA revealed that 95 genes affect blood |
| enhance the immune system in children. | | | | cholesterol. Thus, here again, a system of 95 genes, |
| Let's consider the procedure in more detail. A number | | | | and likely 95 or more molecules, is affecting |
| of sources for potent stem cells exist in the body, | | | | cholesterol levels. Likewise, when stem cells are |
| including adipose (fat) tissue. Fat provides a reservoir | | | | injected into the body where they release their |
| for mesenchymal stem cells, where the stem cells | | | | multitude of molecules, a systems approach to |
| reside in a dormant state until they are recruited for | | | | healing, and therefore an approach with high efficacy, |
| purposes of healing. Mesenchymal stem cells are a | | | | is being administered. Further, in the case of |
| type of stem cell that has been shown to promote | | | | autologous procedures, one is receiving the multitude |
| healing of many types of tissue. Using a needle and | | | | of stem cell released molecules (termed the SRM at |
| syringe, a small amount of fat is extracted from the | | | | BioRegenerative Sciences, Inc.) from one's own body; |
| patient's thigh, for example. This can be a simple | | | | a personalized medical procedure where the |
| out-patient procedure. Fat can also be, of course, | | | | molecules are genetically matched to the |
| extracted from the patient during more extensive | | | | patient. This systems approach in the healing |
| cosmetic liposuction procedures. Once a small amount | | | | process mediated by stem cells renders the |
| of fat has been extracted, the fat is processed in | | | | administration of stem cells to the patient as the |
| the lab using a centrifuge procedure to separate the | | | | foremost means for delivering "personalized |
| stem cells. | | | | regenerative medicine" to the patient. |