Stem cells are the primordial cells in the human body. The first stem cells occur inside a developing embryo (blastocyst). These embryonic stem cells are understood to be totipotent (capable of differentiating into every cell type). They divide and differentiate to ultimately construct the entire human body.
Many of the currently incurable diseases associated with aging are caused by the degeneration of specific cell types in the body. These include but are not limited to: cancer, heart disease, diabetes, neurodegenerative diseases (MS, ALS, PD) and auto immune conditions.
Stem Cell Therapy involves the introduction of healthy new stem cells to repair and replace damaged or lost cells. This therapy, often referred to as Regenerative Medicine provides much promise for the treatment of what was previously regarded as incurable diseases.
The power of stem cells was first harnessed for medical application in 1956, when a pioneering Bone Marrow Transplant was performed by Dr. E. Donnall Thomas. The allogenic (donor) transplant generated a complete remission in a leukemia patient. Dr. Thomas and Joseph E. Murray are co-winners of the 1990 Nobel Prize in Physiology or Medicine "for their discoveries concerning organ and cell transplantation in the treatment of human disease." The cells responsible for generating a 40-80% full remission rate in this application are adult stem cells derived from donated bone marrow.
In 1988, Elaine Gluckman substituted allogenic (donor) cord blood for a traditional bone marrow transplant to treat the blood disease (Fanconi's Anemia) of Keone Penn. The boy remains completely disease free to this day. Since then the blood from a single unpurified cord has been used in an estimated 15,000 treatments worldwide for blood cancers and blood diseases.
In 1998, James Tompson at the University of Wisconsin isolated the first embryonic stem cells from the blastocyst of a five day old in vitro fertilized egg. This discovery launched an avalanche of scientific press, inspired countless studies, and spurned the feverous debate over the ethical issues surrounding embryo destruction for medical advancement.
In 2002, Catherine Verfaillie at the University of Minnesota showed that CD34+ stem cells from bone marrow could repopulate every single cell in a developing mouse. This controversial study alluded to the plasticity of an adult stem cell to generate far more than just blood cells. Suddenly the therapeutic potential of adult stem cells widened from blood cancers and diseases to treatment of a wide range of degenerative illnesses and injuries.
In 2004, Duke University published data from a human study confirming the Verfaillie study detailing the heart treatment of a boy with CD34+ stem cells derived from donated cord blood. This study proved that cord blood stem cells
1) Migrate or "home" to the site of disease
2) Differentiate into specialized heart cells
3) Engraft yielding clinical benefit.
Further investigation showed differentiation to neurons and other cell types.
Embryonic Stem Cell (ESC) Therapy - theoretically involves the use of cells extracted from a five day old in vitro fertilized embryo. ESCs have been scientifically substantiated to be totipotent for all cell types. In the last 6 years, ground breaking laboratory and animal studies have generated international interest.
Certain factors complicate the commercial viability of ESCs. Because only small numbers of slow growing ESCs can be derived from an embryo, cells must be expanded (grown) in the laboratory using a mouse feeder layer. This animal contaminant renders expanded cells unsuitable for human use. Other methods of ESC expansion are under development, however all current US NIH approved cell lines available for research were generated using mouse feeder layers and the creation of new cell lines has been banned by the US.
Ethical issues, animal contaminations, politics, expense and availability have presented obstacles to human clinical trials. To date, ESCs have never been used in human clinical trials or commercially available treatments.
Fetal Stem Cell (FSC) Therapy - involves the use of human fetuses aborted between 1 and 3 months. Tissue with imbedded stem cells is scraped from the liver, neural or gonadal ridges. Commercial providers of these potentially pluripotent cell types do not scientifically classify the cell populations. The provided cells are imbedded in chunks of fetal tissue, making them difficult to quantify.
While research data from FSCs is promising, therapeutic application of human FSC has not been substantiated by published journal studies. The currently available human FSC therapy is scientifically unclassified and ethically controversial.
Adult Stem Cell (ASC) Therapy - typically involves the use of stem cells derived from bone marrow, although ASCs have recently been sourced from peripheral blood and some tissues. Bone Marrow Transplants (BMT) have been used in therapeutic applications since the 1956. BMT preceded by high dose chemotherapy has become an international medical industry standard for treatment of blood cancers and many blood diseases.
BMTs have generated a high remission rate in thousands of treatments worldwide. However, ASCs are understood to be 1/1000th as powerful as the stem cells from cord blood, as they have endured the stresses of age, toxicity and often disease. Limitations to this therapy include: Risk of Graft Versus Host Disease (GVHD), difficulty in obtaining HLA matched donors.
Whole Cord Blood Stem Cell (CBSC) Therapy - involves the use of stem cells derived from full term births via informed consent donations. CBSCs are under nine months old and this timing is particularly advantageous to clinical application. Cord Blood Stem Cells are not like ESCs or FSCs, programmed to slowly build an entire organism, CBSC are programmed to rapidly support the development and growth of all body systems. They expand easily into high numbers in the lab with no need for animal feeder layers. Stem cells from cord blood are pluripotent and versatile, capable of differentiating into every single specialized cell in the body.
Human study data is extensive. However, whole donor cord blood (including white blood cells) not perfectly HLA matched (1:1,000 chance) carries is a 10% risk of GVHD. CBSC transplants are not approved by the FDA. However, CBSC treatment is often implemented by the medical industry as a replacement for BMTs and has been used successfully in thousands of treatments worldwide. CBSC therapy is only available (outside of clinical trials) if the participant is diagnosed with a blood cancer or disease, when a partially HLA matched cord is available.
Purified and Potentiated Cord Blood Stem Cell (PP-CBSC) Therapy -- involves the use of proprietary protocols to remove the white and red blood cells from cord blood, leaving only stem cells. This process negates the risk of GVHD and the need for HLA matching.
ACT has focused its research and development on further enhancing this type of therapy by improving the efficacy and viability of the cord blood stem cells. This has been achieved through a proprietary protocol used to potentiate certain
CD34+ parent populations present in the cord blood. This potentiation provides for greater pluripotency of the cells and therefore enhances their ability to be able to home, differentiate and engraft, thus generating a more effective overall treatment.
In house studies have shown an increase in efficacy from 40% using currently available CBSC purification protocols to 80% using ACT's CBSC Purification and Potentiation protocols.
ACT has also developed a proprietary freeze media which ensures a significantly stronger post thaw viability than other cell vials produced using traditional freeze media and methods. Third party studies have shown that ACT freeze media increases post thaw viability by >70% against other commonly used freeze medias.
1) ETHICAL ACT stem cells are derived exclusively from human umbilical cords of full term births under informed consent donations and are therefore not subject to "right to life" or ethical issues.
2) SAFE ACT stem cells are certified infectious disease free in accordance with International Blood Bank safety standards.
3) PURIFIED ACT has developed a proprietary protocol which removes red and white blood cells from whole cord blood, resulting in a safer and more effective stem cell therapy. With ACT cells, there is no need for blood typing or HLA matching.
4) POTENTIATED
ACT has developed a proprietary method of potentiating populations of stem cells, resulting in a more powerful and effective Cord Blood Stem Cell Therapy.
Certain populations of cord blood stem cells are more poweful than others.
The parent cells of CD34+ cells comprise 10% of the stem cells of a normal cord and understood to be more pluripotent and therefore have enhanced capacities for homing, differentiation and engraftment. ACT expands this population to comprise 70-80% of the stem cells in each sample.
5) VIABLE ACT has developed a proprietary freeze media which generates significantly increased viability of the cells following the freeze/thaw process. Viability studies show the percentage of living cells. Clonogenic capacity (CC) shows the cells ability to expand and differentiate. The consequence and problem of the freeze process is that cells can lose a large percentage of their viability and clonogenic capacity following defrost. Third party studies have shown that ACT freeze media increases post thaw viability by >70% against other commonly used freeze medias.
6) TESTED ACT cells have been third party tested for cell type, count, viability, purity, clonogenic capacity, differentiation capacity and safety.
7) STANDARDIZED
ACT lines are manufactured using Good Laboratory Practice (GLP) by a team of specialized researchers. All vials are stored under highly monitored vapor phase liquid nitrogen conditions which ensure extended uncompromised viability. All vials are transported on dry ice using time sensitive medical couriers.
8) TARGETTED ACT has developed proprietary condition specific administration protocols and pre-treatments, tailored to each patient, to maximize the targeting of cells to areas of need. These protocols again maximize the potential benefits of the therapy without the risks associated with invasive surgical techniques.
9) ACCESSIBLE
Treatment with ACT cells is available at international locations from a qualified MD. A complete treatment requires under 3 hours of clinic time.
10) PROVEN - ACT cells have been used over 700 times in 80 different conditions spanning 4 years with no reported negative side effects.
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