Stem Cells From Menstrual Blood Show Treatment Potential

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Cryo-Cell International announced results of a study published this month in Cell Transplantation showing that stem cells found in menstrual blood proliferate rapidly and have significant potential to develop into multiple cell types. Menstrual stem cells offer an easily accessible, non-controversial and renewable stem cell source, and these findings could mean these cells have the potential to one day treat a host of diseases.

The study, "Multipotent Menstrual Blood Stromal Stem Cells: Isolation, Characterization and Differentiation," was conducted by researchers at Cryo- Cell International who originally discovered the stem cells. According to the study, the stem cells in menstrual blood, known as MenSCs, are stromal stem cells, meaning they have the capability to differentiate into important cells, such as such as bone, cartilage, fat, nerve and cardiogenic cells. The study also found that the cells divided rapidly and plentifully, indicating a possible therapeutic value.

With additional studies of the cells in a variety of categories, the use of these cells may lead to treatments for a number of serious diseases, such as osteoporosis, stroke, Alzheimer's and Parkinson's disease. The cells may even one day be used for customized anti-aging or sports medicine treatments.

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"These findings demonstrate that this novel cell population is adequately potent to one day be a routinely and safely isolated source of stem cells," said Julie Allickson, Ph.D., study investigator and Vice President, Laboratory Operations, Research and Development at Cryo-Cell International, Inc. "Clinical trials are now underway to test the safety and efficacy of MenSCs in animal models for diabetes, neurodegenerative and cardiovascular regenerative therapies."

"As we research several sources of stem cells for their potential therapeutic benefits, we look for cells to emulate embryonic stem cells in that they have the ability to grow rapidly and to become many different types of cells," said Dr. Camillo Ricordi, director of the Cell Transplant Center and the Diabetes Research Institute at the University of Miami. "These menstrual stem cells could have several of the embryonic stem cell attributes, in addition to being easily extracted, not controversial and renewable."

During the study, the investigators analyzed shed menstrual blood and tissue to identify MenSCs. The samples were obtained using a menstrual cup and transferred to a laboratory for processing. At the lab, the cells were quality control-tested and grown in culture to allow for expansion and to assess their growth capabilities. Further analyses were conducted to assess the cells' ability to differentiate into new cell lines, in order to determine which diseases the cells may be used to treat. The average cell collection from a sample of menstrual blood was approximately five million, of which 75 percent of the cells were considered viable. Importantly, the cells rapidly expanded at a doubling rate of 24-36 hours, starting with 50,000 cells on day one and culminating into 48 million cells in less than one month.

"This promising study is the first of many we are conducting in collaboration with leading researchers and institutions with the ultimate goal of using these stem cells to develop groundbreaking future treatments," said Mercedes Walton, Cryo-Cell's Chairman and CEO. "These initial findings offer scientific support and validation for women who are interested in preserving their own menstrual blood stem cells for potential future benefit."

Based on the results of the study, Cryo-Cell is pursuing further research into menstrual stem cells. Cryo-Cell is organizing a number of research and development agreements in efforts to develop promising regenerative therapies utilizing C'elle technology in cardiology, diabetes and neurological diseases. Results from these studies are expected in the next year. The Company is actively seeking to expand its portfolio of research collaborations with scientists worldwide interested in studying this novel stem cell population for regenerative therapeutic development. Cryo-Cell's C'elle(SM) service, which was introduced in November, 2007, is the first available product that enables women to collect menstrual flow containing stem cells, which can then be cryogenically preserved in a manner similar to stem cells from umbilical cord blood.

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Over 100 years ago, a Russian histologist suggested stem cells be applied for scientific research. They are the human body’s equivalent of a generator, as they can renew, regenerate, and replicate under the right conditions. The apex of cellular therapy and regenerative/reparative medicine has been reborn after an 8 year moratorium that basically halted federal funding for stem cell research with most states in the U.S. Now the NIH can award grants to scientists involved with biomedical research involving stem cell therapy through the CMS to each state in the U.S. While never banned, stem cell research had limited funding during this time. And this was unfortunate, because there are several likely uses of stem cells. These uses include the replacement of tissues in the human body, as well as repairing cell types that are defective. Also, stem cells can deliver genetic therapies that are needed in certain patients. ESCs are totiplotent if obtained from the morula which is a pre-blastocyst stage. Normally, the stem cells are acquired from the blastocyst itself. From this source, the stem cells can be any cell in the human body except for the placenta, and are pluripotent. Embryonic stem cells are obtained from a 4 day old embryo called a blastocyst, and are pluripotent from this source. The blastocyst contains about 100 cells, and is not suitable at this stage for implantation into the uterine wall. The inner core of the blastocyst has about 20 cells, and this is where stem cells are obtained. These cells are unspecialized cells that can be developed or morphed into the over 200 cells available in the human body through differentiation, as ESCs are undifferentiated by nature. As such, they can become any human cell, as long as they are prevented from clumping or crowding together when explanted into cultures as they are propagated. After stem cells are cultured, they are moved to what are called stem lines. Until recently, ESCs were believed to be most beneficial instead of the adult stem cell alternative (ASC), as these stem cells are limited to application to the tissue the stem cells were obtained from only. However ASCs (somatic stem cells) now can be coerced into differentiation through plasticity (trans-differentiation). This likely will reduce if not eliminate those opposed to stem cell therapy because of moral and ethical reasons related to the utilization of ESCs. Thanks to molecular biology, four transcription factors control the transfer of genetic information from DNA to RNAS to regulate gene expression. So ASCs can have the same beneficial qualities as ESCs. In the past, viral vectors and exotic genes interfered with the purity of ASCs. Now ASCs are re-programmed using plasmids instead of viruses and oncogenes that can become detrimental for the patient treated. So now, ASCs can safely become induced pluripotent cells with the same potential as ESCs. As a result, the ASCs are free of genetic artifacts that potentially can interfere with transgene sequences. They are capable of, and are able to renew and reproduce with minimal effort, stem cells, under the right laboratory conditions. Human blood can be reproduced with stem cells under the right conditions, it has been shown by researchers. SCT can also be used to investigate disease states for better treatment options. Disease-specific stem cell lines, which are those cells that are pluripotent and are created with the same genetic errors of certain diseases, are studied for this reason. So there clearly is a huge potential for stem cell-based therapies. The first FDA approved clinical trial occurred early in 2009. This human trial will involve evaluating primarily the safety of ESCs designed to be used as treatment for spinal cord injury patients. The trial was submitted by Geron Corp. Pfizer, the largest drug company, has implemented stem cell research, as they are an asset to drug discovery by creating within the organization a regenerative medicine unit. Other large pharma companies are implemented similar research protocols for the same reasons. Geron Corp. in California is the world’s leading esc developer, and financed researchers at Univ. of Wisconsin, who isolated the first human esc in 1998. Stem cell therapy potentially can cure multiple sclerosis, among other disases and those with damaged human tissue. The therapy prevents the advancement of disease, as well as reverses the neurological dysfunctions associated with MS. Patients are injected with their own stem cells obtained from their bone marrow, which are called haemopoietic stem cells. These particular stem cells are the origin of all blood cells. Further large clinical trials are needed to support these results. Studies have shown between 70 and 80 percent of MS patients who received stem cell therapy did not relapse afterwards. Allogenic, or donor transplants, have a risk of graft versus host disease. Autologous, which is the patient’s own stem cells, are preferable and most beneficial. Similar results from this autologous bone marrow transplant cellular therapy are seen with Chron’s disease as well. During the procedure, the immune system is reset so it is not in an autoimmune state where it attacks the human body. The process lasts about 2 months, and consists of 6phases: 1. Initial chemo 2. Release of stem cells 3. Acquisition of stem cells 4. Cells are then frozen until ready for transplant 5. Second chemo to reduce leukocytes 6. Autologous stem-cell transplant. Immune system is reset. Positive results from stem cell therapy are seen usually within a month, and patients can request another treatment about 6 months after the first treatment presently. This stem cell paradigm of therapy addresses the etiology of a disease state, instead of focusing on the symptoms only. As such, this is the practice of regenerative medicine with the implementation of SCT. Some believe ethical restraints are needed regarding the use of ESCs for therapeutic reasons. Yet they improve the quality of life of those with devastating diseases which involves suffering without any relief. So stem cell therapy and research may be the most right and ethical thing to do for such patients. Not only is the tremedous suffering relieved with those possessed with devistating diseases, their functional ability is restored for those who receive stem cell therapy. Embryos are acquired from fertility clinics (IVFs) that have thousands routinely stored and are abnormally fertilized. This means that they could never go on to become a human, and would be destroyed otherwise. Ironically, one could argue it is inappropriate to discard what may be valuable and ethical for others, potentially. Most couples with frozen embryos would gladly give them to such research, surveys have concluded. These embryos are believed by many to not be morally equivalent to human life, but only have the potential for life. And they are used for therapeutic cloning, known as somatic cell nuclear transfer, and not reproductive cloning. Ten states have banned this cloning out of ignorance, it seems. Bioethic principles, which are beneficience, or physician-centered decisions, as well as non-maleficence, which is first do no harm, are not corrupted. Furthermore, autonomy, which is the patient’s right to determine their health, and justice or fairness remain intact. Stem cells should be utilized for those terminally ill as well, many believe. Many are seeking stem cell therapy overseas due to retrictions that exist in the U.S. presently. The United Kingdom is believed to be the leader in stem cell research presently. Dan Abshear