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Cryo-Cell Launches Virtual Broadcast Center With Presentation of “The Discovery of C’elleSM: Novel Adult Stem Cell Found in Menstrual Blood”

C’elle Virtual Broadcast Center Launches on July 10th at 12 noon EDT; Ground-Breaking Stem Cell Research and Introduction of C’elle, the Innovative New Service to Preserve Stem Cells Found in Menstrual Blood to be Showcased

Oldsmar, Fla.– Cryo-Cell International, Inc. (OTCBB: CCEL.OB), one of the largest and most established family cord blood banks in the nation, will broadcast the  discovery of its breakthrough stem cell technology with the launch of the C’elle Virtual Broadcast Center (http://www.or-live.com/vbc/crc/) on Thursday, July 10th, at 12 noon EDT. C’elle is the world’s first service for women to store their own menstrual stem cells for future use.

The virtual broadcast, produced by OR Live, will showcase Cryo-Cell’s latest scientific findings on how a woman’s menstrual flow— which results from the shedding of the uterine lining (endometrium) during menstruation, contains millions of  stem cells that have many properties and characteristics similar to those of both bone marrow and embryonic stem cells. The broadcast will include details about the study, the cell characteristics, information about several preclinical studies currently under way, and an overview of the C’elle service.

Through several independent laboratory research studies, these menstrual stem cells have demonstrated the capability in vitro to differentiate into neural, cardiac, bone, cartilage, and adipose cells and possibly other cell types. Although research is preliminary, given their properties, Cryo-Cell believes that these menstrual cells demonstrate compelling promise to transform regenerative medicine in coming years.

“Stem cells isolated from menstrual blood are multi-potent, highly prolific and readily accessible,” said Julie Allickson, PhD, MS, MT (ASCP) Vice President of Laboratory Operations and Research & Development. “These novel stem cells demonstrate characteristics of both bone marrow mysenchemal stem cells and embryonic stem cell markers that may potentially demonstrate significant promise for future use in clinical regenerative medical therapies.”

On November 1, 2007, Cryo-Cell announced the introduction of C’elle, a service which enables women to collect stem cells found in menstrual fluid, which can be cryogenically preserved in a manner similar to stem cells from umbilical cord blood. And like stem cells found in cord blood, these vital cells may one day serve as a potential source for promising regenerative therapies to treat heart disease, diabetes, and neurological disorders like spinal cord injury, Parkinson’s and Alzheimer’s diseases, in addition to cosmeceutical applications such as anti-aging therapies. 

Preliminary research related to the immunological profile of these unique menstrual stem cells suggests the that in addition to the donor, these stem cells may also potentially be used to benefit other family members who are genetically related to the donor, such as perhaps a parent, sibling or child.

About Cryo-Cell International, Inc.

Based in Oldsmar, Florida, with over 150,000 clients worldwide, Cryo-Cell is one of the largest and most established family cord blood banks. ISO 9001:2000 certified and accredited by the AABB, Cryo-Cell operates in a state-of-the-art Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP)-compliant facility. Cryo-Cell is a publicly traded company. OTC Bulletin Board Symbol: CCEL. For more information, please call 1-800-STOR-CELL (1-800-786-7235) or visit www.cryo-cell.com.

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Menstrual Blood Shows Heart Repairing Stem Cell Properties

Medical News Today
Article Date: 25 Apr 2008 - 3:00 PDT

Scientists in Japan have discovered that cells taken from menstrual blood can be cultivated in the lab and used like stem cells to repair damaged heart tissue.

The initial results of the work were published last week in the journal Stem Cells. The study was the work of corresponding author Dr Shunichiro Miyoshi, a cardiologist at Keio University School of Medicine, in Tokyo, and colleagues, including scientists from the National Research Institute for Child Health and Development in Tokyo, Tokyo Women's Medical University, and Kanazawa University.

Stem cells can be used to repair damaged tissue because they have the potential to become any cell in the body.

However, while scientists are developing numerous uses for stem cells, getting hold of them is not easy and many harvesting techniques involve invasive procedures.

Miyoshi and colleagues discovered that menstrual blood contains precursos cells that can be used to develop cardiac stem-cell therapeutic material, and these cells appear to have greater potential for this than cells from bone marrow.

Nine women volunteered to donate menstrual blood from which the scientists harvested the precursor cells, called mesenchymal cells (MMCs) and cultivated them for a month.

After being put together in a culture with cells from the hearts of rats, about 20 per cent of MMCs began beating spontaneously and eventually formed sheets of heart muscle tissue.

According to a report by AFP news agency, this success rate is about 100 times higher than the 0.2 to 0.3 per cent of stem cells derived from human bone marrow.

The MMCs showed many of the signs typical of cardiomyocytes, the precursor cells to heart muscle cells.

For instance, up to 32 per cent of them tested positive for troponin-I (a heart muscle protein), and they multiplied for 28 generations, on average, without affecting their potential to produce heart muscle cells.

Another set of experiments showed that live rats that had suffered heart attacks improved after being implanted with the MMCs. The researchers saw that the implanted MMCs gave rise to cardiomyocytes in the rats' hearts and decreased the myocardial infarction (MI) area.

The researchers concluded that:

"MMCs appear to be a potential novel, easily accessible source of material for cardiac stem cell-based therapy."

Miyoshi told AFP yesterday, Thursday 24th April, that one day women could use their menstrual blood for their own treatment. This would overcome the major problem of immune system rejection.

Another useful application could be to use menstrual blood to stockpile cells with a range of matching HLAs, human leukocyte antigens, important immune system agents.

He also suggested, because the MMCs have the potential to develop into muscle cells, that perhaps another application could be to treat muscular dystrophy, a range of genetic diseases that destroy muscle tissue.

Miyoshi told AFP that he was not entirely happy with the results of the experiment on the rats' hearts. He wants to find out what exactly happens to convert the MMCs into heart cells.

"I guess this can't be ready for clinical use yet," he said.

Another study by US researchers, reported yesterday in Medical News Today, also showed how multipotential stem cells could be provided by menstrual blood.

"Novel Cardiac Precursor-Like Cells from Human Menstrual Blood-Derived Mesenchymal Cells."
Naoko Hida, Nobuhiro Nishiyama, Shunichiro Miyoshi, Shinichiro Kira, Kaoru Segawa, Taro Uyama, Taisuke Mori, Kenji Miyado, Yukinori Ikegami, ChangHao Cui, Tohru Kiyono, Satoru Kyo, Tatsuya Shimizu, Teruo Okano, Michiie Sakamoto, Satoshi Ogawa, Akihiro Umezawa.
Stem Cells Express, first published online April 17, 2008.
DOI:10.1634/stemcells.2007-0826

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Stem Cells from Menstrual Blood Show Therapeutic Potential
Data in Cell Transplantation Demonstrates Capacity of Menstrual Stem Cells

Oldsmar, Fla. – April 14, 2008 – Cryo-Cell International, Inc. today 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.

“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’elleSM 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.

About Cryo-Cell International, Inc. (OTCBB: CCEL.OB)
Based in Oldsmar, Florida, with over 150,000 clients worldwide, Cryo-Cell is one of the largest and most established family cord blood banks. ISO 9001:2000 certified and accredited by the AABB, Cryo-Cell operates in a state-of-the-art Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP)-compliant facility. Cryo-Cell is a publicly traded company. OTC Bulletin Board Symbol: CCEL. For more information, please call 1-800-STOR-CELL (1-800-786-7235) or visit www.cryo-cell.com.

  • Forward-Looking Statement
    Statements wherein the terms “believes”, “intends”, “projects” or “expects” as used are intended to reflect “forward-looking statements” of the Company. The information contained herein is subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated in such forward-looking statements or paragraphs, many of which are outside the control of the Company. These uncertainties and other factors include the uncertainty of market acceptance of any potential service offerings relating to types of stem cells other than cord blood stem cells, including the C’elle service, given that menstrual stem cells and other new stem cells have not yet been used in human therapies, and treatment applications using such stem cells are not likely to be developed and commercialized for many years and are subject to further research and development; the need for additional development and testing before determining the ultimate commercial value of the Company’s intellectual property relating to the menstrual stem cells; the need to complete certain developments, including completion of clinical validation and testing, before any new process other than C’elle can be commercialized, and the Company’s development of its final business and economic model in offering any such service; any adverse effect or limitations caused by recent increases in government regulation of stem cell storage facilities; any increased competition in our business; any decrease or slowdown in the number of people seeking to store umbilical cord blood stem cells or decrease in the number of people paying annual storage fees; any adverse impacts on our revenue or operating margins due to the costs associated with increased growth in our business, including the possibility of unanticipated costs relating to the operation of our new facility; any technological breakthrough or medical breakthrough that would render the Company’s business of stem cell preservation obsolete; any material failure or malfunction in our storage facilities; any natural disaster such as a tornado, other disaster (fire) or act of terrorism that adversely affects stored specimens; the costs associated with defending or prosecuting litigation matters and any material adverse result from such matters; decreases in asset valuations; any continued negative effect from adverse publicity in the past year regarding the Company’s business operations; any negative consequences resulting from deriving, shipping and storing specimens at a second location; and other risks and uncertainties. The foregoing list is not exhaustive, and the Company disclaims any obligations to subsequently revise any forward-looking statements to reflect events or circumstances after the date of such statements. Readers should carefully review the risk factors described in other documents the Company files from time to time with the Securities and Exchange Commission, including the most recent Annual Report on Form 10-KSB, Quarterly Reports on Form 10-QSB and any Current Reports on Form 8-K filed by the Company.
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    Cryo-Cell Launches C’elle, First-Ever Proprietary Menstrual Stem Cell Service
    Company’s Newly Discovered Stem Cell Shows Promising Potential in Regenerative Medicine

    Oldsmar, Fla. – Nov. 1, 2007 – Cryo-Cell International Inc. (OTCBB: CCEL.OB) (“Cryo-Cell” or the “Company”), one of the largest and most established family cord blood banks, today announced its discovery of breakthrough stem cell technology and its launch of the world’s first-ever service provided for women to store their own menstrual stem cells. The new service, called C’elleSM  (pronounced “C-L”), enables women to collect menstrual flow containing stem cells, which can be cryogenically preserved in a manner similar to stem cells from umbilical cord blood and may one day serve as a potential source for promising regenerative therapies to treat heart disease, diabetes, neurological disorders like spinal cord injury, Parkinson’s and Alzheimer’s diseases, in addition to cosmeceutical applications such as anti-aging therapies, to name a few.  However, realistically, it may take several years for these menstrual stem cells to be developed into potential widely-available commercial therapies. The C’elle service is based on Cryo-Cell’s intellectual property, for which patent applications are pending, related to the procurement, processing, isolation and cryo-preservation of these unique menstrual stem cells.

    The unique C’elle service is being offered following Cryo-Cell’s discovery of new scientific evidence that menstrual flow, which results from the shedding of the uterine lining (endometrium) during menstruation, contains millions of stem cells that have many properties and characteristics similar to those of both bone marrow and embryonic stem cells. Dr. Amit N. Patel, Director of Cardiac Stem Cell Therapies at the McGowan Institute, University of Pittsburgh Medical Center, along with other independent research laboratories, studied these menstrual stem cells, which have demonstrated the capability in vitro to differentiate into neural, cardiac, bone, cartilage, and adipose cells, and possibly other cell types.  Dr. Patel’s preliminary findings were presented on October 21, 2007 at TCT 2007, the annual scientific symposia of Transcatheter Cardiovascular Therapeutics, in a seminar entitled “Novel Cell Sources for Myocyte Repair and Replacement”.

    “This is the first discovery of such a multipotent, highly prolific and readily accessible source of stem cells - even one menstrual cycle has the potential to produce millions of stem cells,” said Dr. Stephen Noga, Director, Medical Oncology/Hematology, Alvin & Lois Lapidus Cancer Institute, and Director, Cellular Therapeutics Program, Sinai Hospital of Baltimore. “Stem cells isolated from menstrual blood may show significant promise for future use in clinical regenerative medical therapies. This brings us one step closer to tissue and organ regenerative approaches. They are adult stem cells, but they share some of the same features of embryonic stem cells in their ability to multiply rapidly and differentiate into other cell types of the body. Current research is very preliminary, but given their properties, we believe these menstrual stem cells demonstrate compelling promise to transform regenerative medicine in the coming years.”

    Dr. Gerald Elfenbein, a Professor of Medicine at Boston University, former director of the Cancer Center and Blood and Marrow Transplant Program at Roger Williams Medical Center, Providence, R.I., and former division chair of the Blood and Marrow Transplant Program at H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla. believes the impact to the research and medical communities is significant. “I’ve been in the stem cell transplant world for more than three decades, and this finding follows in a long tradition of bench-to-bedside research,” he said. “This discovery has the potential to offer significant benefit to the research community by accelerating the pace of study, and I look forward to seeing the possible clinical results we can achieve in the future.”

    The use of these unique menstrual stem cells in other pre-clinical studies for human cardiovascular and neurodegenerative regenerative therapies is also under evaluation. Preliminary research related to the immunological profile of these unique menstrual stem cells suggests that in addition to the donor, these stem cells may also potentially be used to benefit other family members who are genetically related to the donor, such as perhaps a parent, sibling or child.

    “Cryo-Cell’s discovery of these unique menstrual stem cells and the processes associated with their procurement, processing, isolation and cryo-preservation, is an extraordinary milestone for the Company,” stated Mercedes Walton, Cryo-Cell’s Chairman and CEO. “We are very excited that our revolutionary new service, C’elle, based on the Company’s proprietary technology, is now available to the public.  Over the past year, Cryo-Cell has made significant progress in the study of these unique menstrual stem cells and commercialization of related processing services.  The Company is pleased to collaborate with world-class researchers from many different fields of medicine to explore possible utilization of these stem cells in the development of potential breakthrough therapies that may possibly benefit millions of people in the future. In the months ahead, we eagerly anticipate emerging developments related to the Company’s novel technology and innovative proprietary service.”

    Beginning today, the C’elle service is exclusively available from Cryo-Cell and may be used by any woman who menstruates. It is currently estimated, however, that over 100 million women in the U.S. alone experience menstrual cycles. The Company believes that the C’elle service offers women no matter what their age, with the unique opportunity to preserve “Your Monthly MiracleSM” while they are in good health and have access to this distinctive source of stem cells.  With global advancements in stem cell research and development, the C’elle service offers a unique family healthcare asset that may potentially increase in value over time as breakthrough regenerative stem cell therapies emerge in the future.  Detailed information about the C’elle service is available at www.celle.com.

    About Cryo-Cell International, Inc.
    Based in Oldsmar, Florida, with over 140,000 clients worldwide, Cryo-Cell is one of the largest and most established family cord blood banks. ISO 9001:2000 certified and accredited by the AABB, Cryo-Cell operates in a state-of-the-art Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP)-compliant facility. Cryo-Cell is a publicly traded company. OTC Bulletin Board Symbol: CCEL. For more information, please call 1-800-STOR-CELL (1-800-786-7235) or visit www.cryo-cell.com.

  • Forward-Looking Statement
    Statements wherein the terms “believes”, “intends”, “projects” or “expects” as used are intended to reflect “forward-looking statements” of the Company. The information contained herein is subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated in such forward-looking statements or paragraphs, many of which are outside the control of the Company. These uncertainties and other factors include the uncertainty of market acceptance of any potential service offerings relating to types of stem cells other than cord blood stem cells, including the C’elle service, given that menstrual stem cells and other new stem cells have not yet been used in human therapies, and treatment applications using such stem cells are not likely to be developed and commercialized for many years and are subject to further research and development; the need for additional development and testing before determining the ultimate commercial value of the Company’s intellectual property relating to the menstrual stem cells; the need to complete certain developments, including completion of clinical validation and testing, before any new process other than C’elle can be commercialized, and the Company’s development of its final business and economic model in offering any such service; any adverse effect or limitations caused by recent increases in government regulation of stem cell storage facilities; any increased competition in our business; any decrease or slowdown in the number of people seeking to store umbilical cord blood stem cells or decrease in the number of people paying annual storage fees; any adverse impacts on our revenue or operating margins due to the costs associated with increased growth in our business, including the possibility of unanticipated costs relating to the operation of our new facility; any technological breakthrough or medical breakthrough that would render the Company’s business of stem cell preservation obsolete; any material failure or malfunction in our storage facilities; any natural disaster such as a tornado, other disaster (fire) or act of terrorism that adversely affects stored specimens; the costs associated with defending or prosecuting litigation matters and any material adverse result from such matters; decreases in asset valuations; any continued negative effect from adverse publicity in the past year regarding the Company’s business operations; any negative consequences resulting from deriving, shipping and storing specimens at a second location; and other risks and uncertainties. The foregoing list is not exhaustive, and the Company disclaims any obligations to subsequently revise any forward-looking statements to reflect events or circumstances after the date of such statements. Readers should carefully review the risk factors described in other documents the Company files from time to time with the Securities and Exchange Commission, including the most recent Annual Report on Form 10-KSB, Quarterly Reports on Form 10-QSB and any Current Reports on Form 8-K filed by the Company.
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    Promising Stem Cells Discovered in Menstrual Blood; Cryo-Cell Launches World's First-Ever Collection and Storage Service, C'elle

    Today, November 1, 2007, Cryo-Cell announced its discovery of a new, unique type of stem cell found in menstrual blood that may one day have the potential to treat a number of diseases. Cryo-Cell also launched an exclusive and proprietary new service, called C’elle, to enable women to collect and cryopreserve their menstrual stem cells. Following are key facts and a list of experts from Cryo-Cell and leading academic institutions who are available for comment.

    Menstrual Stem Cells

    • Cryo-Cell has discovered unique stem cells in menstrual blood that express multipotent markers of both adult and embryonic stem cells. These menstrual stem cells multiply quickly and can differentiate into other types of cells, including heart, nerve, bone, cartilage and fat, according to early research.
    • The menstrual stem cells appear to have characteristics similar to those derived from the uterus (human endometrial stem cells), but they can be easily harvested in a non-invasive manner from menstrual fluid.
    • This is the first time researchers have found an adult stem cell that is highly prolific and multipotent (able to differentiate into other cell types), and can also be easily harvested in a painless, non-invasive manner as compared to other stem cell sources such as bone marrow, fat or adult peripheral blood.
    • Several leading stem cell researchers have launched preclinical studies to evaluate the potential of these unique menstrual stem cells to treat heart disease, Type 1 diabetes and spinal cord injury.
    • Researchers believe that these menstrual stem cells could someday be used treat other serious illnesses, such as osteoporosis, stroke, Alzheimer’s and Parkinson’s disease, and that the cells may even be used for customized anti-aging or sports medicine treatments. However, current research is very preliminary and it may take years to develop widely available clinical therapies.
    • Menstrual stem cells’ unique properties, combined with their ease of collection and isolation, mean they could become a breakthrough source of multipotent cells. The need for regenerative therapies incorporating cells that have the ability to engraft and differentiate is vast. The ideal cell would also have the ability to be used in an allogeneic manner, meaning it could be used to treat others with whom there is a genetic match. These cells appear to have all of these properties.
    • A summary of research related to the menstrual stem cell can be found at http://www.celle.com/mediaKit.aspx

    C’elle

    • Cryo-Cell has launched a proprietary new service, C’elle (pronounced “C-L”), allowing women to collect and store menstrual stem cells – much like the way umbilical cord blood is preserved.
    • Any woman who experiences menstruation can use C’elle. The collection process is easy and painless. The specimen is transported to Cryo-Cell’s Good Manufacturing Practice/Good Tissue Practice (cGMP/cGTP) laboratory for processing and cryopreservation.
    • C’elle is exclusively available from Cryo-Cell International Inc., a global leader in innovative stem cell solutions. Cryo-Cell is the most established family cord blood bank, with 15 years of experience and more than 140,000 clients worldwide.
    • More information about C’elle can be found at www.celle.com

    Stem Cell Experts Available for Interviews
    For more information on C’elle, or to speak with a Cryo-Cell official, please contact Kellie Hotz, (312) 240-2701, kellie.hotz@edelman.com. In addition, several top stem cell researchers and transplant physicians are available for comment:

    • Dr. Amit N. Patel, Director of Cardiac Stem Cell Therapies at the McGowan Institute, University of Pittsburgh Medical Center
    • Dr. Gerald Elfenbein, Immunology Professor at Boston University
    • Dr. Stephen J. Noga, Director of Medical Oncology and Hematology and the Cellular Therapeutics Program at the Alvin & Lois Lapidus Cancer Institute at Sinai Hospital of Baltimore, Associate Professor of Oncology and Pathology at The Johns Hopkins University School of Medicine
    • Dr. Paul R. Sanberg, Distinguished University Professor and Director of the Center of Excellence for Aging and Brain Repair and Associate Vice President/Associate Dean for Biotechnology Development at the University Of South Florida College Of Medicine.

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    In Early Studies, Menstrual Stem Cells Demonstrate Highly Proliferative Qualities and Differentiate Into Primary Cell Types

    Allickson, Julie, Ph.D., Cryo-Cell International, Inc.

    Background: The lining of the uterus has a remarkable capacity for regeneration after each menstrual cycle. Extraction of this rich source of stem cells can be easy and is non-controversial. We have begun to study the cells released from the uterine lining as a possible source of multipotent stromal stem cells that could be safely and routinely obtained in a renewable fashion, maintain potency to differentiate, and be scalable for clinical use. Based on preliminary studies, we present a novel population of MESCs that express multipotent markers and an ability to differentiate in vitro into multiple cell lines that can be easily expanded for potential clinical applications.

    Program: In order to evaluate the practicality of obtaining multipotent stem cells from the uterus in safe and reproducible manner, we analyzed shed menstrual blood and tissue to identify stromal cells (MESCs). Menstrual cell samples were obtained by using a menstrual cup (Kitchener, ON) with the informed consent of the donor as approved by an institutional review board. Cells were transferred to a processing laboratory within 24-48 hours, upon which the samples were processed, quality control testing performed and cultured to assess functional viability. Cells were grown in culture over several passages to expand and to assess proliferative capabilities of the cells. Further analyses were conducted to assess differentiation into chrondrogenic, adipogenic, osteogenic, neurogenic and cardiogenic cell lineages.

    Results: The MESCs have successfully differentiated in vitro into cell lineages derived from the mesoderm and the ectoderm, such as chondrocytes (cartilage), adipogenic (fat), osteogenic (bone), neural cells and cardiomyogenic cells. The initial results of the study demonstrate an average cell collection of approximately five million cells, and average cell viability of approximately 75 percent. The cells rapidly expanded at a doubling rate of 24-36 hours; starting with 50,000 cells, the team obtained 48 million cells in less than one month. Data demonstrates that the cells express stromal markers such as CD29, CD44, CD73, CD90, CD105, CD166 and pluripotent markers SSEA-4 and Oct-4. The data demonstrate that MESCs are readily expandable and express important multipotent stem cell markers.

    Conclusion: Preliminary studies have demonstrated that MESCs are easily expandable to clinical relevance and express multipotent markers that allow for differentiation in important cell lines. Clinical trials are now underway to test the safety and efficacy of MESCs in animal models for neurodegenerative and cardiovascular regenerative therapies. These studies demonstrate that MESCs are a novel cell population that may be routinely and safely isolated and provide a renewable source of stem cells from child-bearing women.

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    Comparative Matrix for Menstrual Stromal Cells and Bone Marrow Mesenchymal Cells

    Cell Characteristics

    C’elle (Menstrual Stromal Cells)

    BM MSC (Bone Marrow Mesenchymal Cells)

    Cell Collection Procedure

    Non-invasive menstrual cup similar to insertion of a tampon

    Harvest bone marrow in the OR mobilized adult peripheral blood

    Cell Morphology

    stromal, mesenchymal-like, spindle-shaped in culture

    stromal, mesenchymal-like,  spindle-shaped in culture (4)

    Cell Surface Markers associated with mesenchymal cells

    CD29, CD44, CD73, CD90, CD105, CD166
    MHC I+ MHC II-

    CD29, CD44, CD73, CD90, CD105, CD166
    MHC I+ MHC II- (1)(3)

    Markers associated with embryonic stem cells

    SSEA-4, Oct-4

    none

    Differentiation capability

    Neural, Cardiogenic, Chondrogenic, Adipogenic, Osteogenic

    Chondrogenic, Adipogenic, Osteogenic (2)

    MLR

    Cells demonstarted a weak stimulatory response which suggests potential use in first-degree relatives

    Do not elicit alloreactive lymphocyte proliferative responses (1)

    Karotype

    Normal karyotype

    Normal Karyotye (3)

    References:

    1. Le Blanc K, Tammik C, Rosendahl K, Zetterberg E, & Ringdén O. (2003). HLA expression and immunologic properties of differentiated and undifferentiated mesenchymal stem cells. Exp Hematol, 31(10), 890-896.
    2. Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, et al. (1999). Multilineage potential of adult human mesenchymal stem cells.  Science, 284(5411), 143-147.
    3. Kern S, Eichler H, Stoeve J, Klüter H, Bieback, K. (2006). Comparative Analysis of Mesenchymal Stem Cells from Bone Marrow, Umbilical Cord Blood, or Adipose Tissue. Stem Cells, 24(5), 1294 –1301.
    4. Horwitz, Edwin M. (2007). Report on the Workshop "New Technologies in Stem Cell Research," Society  for Pediatric Research, San Francisco, California, April 29, 2006, Fundamentals of MSC Isolation and Purification.Stem Cells, 25(4), 1070 -1088.
    5. Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, et al. (2006). Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction. N Engl J Med, 355(12), 1210-1221.
    6. Horwitz EM, Prockop DJ, Fitzpatrick LA, Koo WW, Gordon PL, et al. (1999). Transplantability and therapeutic effects of bone marrow-derived mesenchymal cells in children with osteogenesis imperfecta. Nat Med, 5, 309–313.

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