StemCell Therapy

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that its chief scientific officer, Robert Lanza, M.D., will be delivering the opening Keynote Speech at the 4th Annual Stem Cell Symposium 2012, being held in Singapore, September 6-7. Dr. Lanzas presentation is titled Pluripotent Stem Cells From Benchtop to Clinic.

With the theme, Stem Cell Based Therapy, the symposium will have a particular focus on clinical trials and industrial application of stem cells. Sponsored by Stem Cell Society of Singapore (SCSS), the conference will include scientific presentations from key contributors from academic, clinical, and commercial organizations who are translating basic research on stem cells into therapeutics, with a focus on applying engineering technologies to provide medical solutions.

In their opening statement, the organizers state, We are all keeping our fingers crossed for ACTs success, which will also bring a big boost to the stem cell community.

Other topics of the conference include human induced pluripotent stem cells (hiPSCs), drug screening, adult and cancer stem cells, and stem cell therapies emerging from Asia, with presentations from Indian, Korean and Japanese regenerative medicine companies. There will also be a joint session with the International Society for Cellular Therapy (ISCT) covering important issues concerning the commercialization of stem cells, and addressing issues such as reimbursement, manufacturing, characterization, and clinical implementation issues unique to cell therapies.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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ACT’s Chief Scientific Officer Dr. Robert Lanza to Deliver Opening Keynote Address at 4th Annual Stem Cell Symposium ...

GAITHERSBURG, MD--(Marketwire -09/04/12)- Cytomedix, Inc. (CMXI) (CMXI), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies, today announced that the Company's AutoloGel System was highlighted in a continuing education program at the Paralyzed Veterans of America Summit 2012 held August 28 to 30 at the Paris Las Vegas Hotel.

The AutoloGel System is a device for the production of autologous platelet rich plasma ("PRP") gel, and is the only PRP device cleared by the U.S. Food and Drug Administration ("FDA") for use in wound management.

The program, titled, "Platelet Rich Plasma (PRP) Gel for Wounds on Persons with SCI," was delivered by Laurie Rappl, PT, DPT, CWS, Clinical Development Liaison for Cytomedix. Ms. Rappl's discussion addressed the underlying mechanisms of action that allow the Company's physiologically relevant concentration of PRP in the AutoloGel System to accelerate healing in recalcitrant wounds in patients with Spinal Cord Injuries ("SCI"), and highlighted the clinical data demonstrating rapid reduction in wound area and volume, as well as reduction of undermining and sinus tracts/tunnels in non-healing wounds in patients with SCI.

"The physiology of SCI -- such as decreased blood flow, blood pressure and blood supply -- causes impairment at every step of the wound healing process. A physiologically relevant concentration of PRP has been shown to improve healing in even the hardest to treat chronic wounds in SCI patients," noted Ms. Rappl.

"It is especially rewarding for Cytomedix to have a continuing education program highlighting the benefits of the AutoloGel System for the treatment of chronic wounds in SCI patients. Pressure ulcers and other chronic wounds are persistent medical challenges that compromise the health and quality-of-life for these paralyzed patients," stated Martin P. Rosendale, Chief Executive Officer of Cytomedix. "Our clinical data demonstrates how the AutoloGel System's physiologically relevant concentration of PRP can rapidly restart the healing process in complex and chronic wounds, including wounds that were recalcitrant to other treatments."

About The Paralyzed Veterans of America SummitParalyzed Veterans' Summit 2012 + EXPO brings together more than 700 healthcare professionals in SCI and multiple sclerosis (MS) care. Doctors, nurses, occupational therapists, physical therapist, social workers and researchers convene to explore and implement holistic strategies to strengthen the continuum of care for SCI and MS patients.

The Paralyzed Veterans of America Summit serves as an educational venue bringing together professionals representing the full spectrum of SCI and MS healthcare and to support clinicians in their pursuit of maintaining their specialty certification and/or license to practice. The objectives are to enhance multi-specialty care across the lifespan of individuals with SCI and MS; to assess advances in the delivery of healthcare services; to present innovative models of care management; to improve practice skills of clinicians, surgeons, researchers and administrators; to discuss evidence-based medicine; to increase the body of knowledge on spinal cord injury and multiple sclerosis, their medical complications and consequences; to promote educational opportunities; to identify research priorities; and to present data on new developments in assessment and treatment.

About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

Safe Harbor StatementStatements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's reimbursement related efforts, the Company's ability to capitalize on the benefits of the above-referenced CMS determination, the Company's ability to successfully and favorably conclude the negotiations and related discussions with the above-referenced global pharmaceutical company, the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011 and other subsequent filings. These filings are available at http://www.sec.gov.

See more here:
Cytomedix's AutoloGel System Featured in Continuing Education Program at the Paralyzed Veterans of America Summit 2012

Cell therapies present unique challenges when complying with this paradigm for several reasons only two of which I will mention here.  Firstly, it is not possible to achieve the level of product purification as one might with other therapeutic products.  Secondly, the product characterization is at a cellular rather than molecular level.

Autologous cell therapies present another set of unique challenge in this paradigm because of the notable patient-to-patient variability where the patient is also the donor of the raw material.  This often means there is a wider tolerance of heterogeneity in the product but it still must be within what has been proven to the regulatory agency as a safe and effective range.  


In cases where an autologous cell therapy is centrally manufactured, they are most often subjected to product release testing similar to that described above.  One notable difference, particularly for fresh products, is that the products may be shipped to the clinic and even administered before the full panel of test results are obtained.  This wold be considered highly unusual (if ever acceptable) with other types of products but is tolerated because of the time-sensitivity of these products and their high safety profile.


In the case of autologous cell therapy products produced at the bedside there is often not the same kind of product release discipline.  Often the regulatory agencies deal with the product consistency and specification compliance issue by ensuring that the cell processing device used point-of-care is validated to ensure the cellular product output is always within a specified range shown to be clinically safe and effective.


The Varying Degree of Product Characterization/Specification of Autologous GTP Cell Therapy Products


However - and now I get to the point of this blog post - for cell-based products, procedures and/or devices/kits which are not mandated to be formally approved by a regulatory agency before they can be commercially marketed, there is no product specification rigor.  Compliance with the Good Tissue Practice regulations and guidance is deemed to ensure safety.  In the United States, cell-based products which are deemed to be "minimally manipulated" and intended for "homologous use" are typically allowed to go straight to market with no formal approval.  Safety and clinical data is not required but is practically necessary to support physician adoption and, where applicable, reimbursement.  


This means that for these products there is a great deal of variability in terms of how much rigor companies apply in characterizing their product and then ensuring that each batch complies with the specifications they themselves have determined to be safe and effective. Again, where such products are manufactured in a centralized facility the likelihood of some release testing is greater.  However, those companies relying on a point-of-care processing kit or device business model that has not been deemed to require formal market approval, rarely (if ever) include product release testing.


The common criticism of these companies is that they simply do not know what they are injecting into patients because of the combination of the patient-to-patient donor variability, the lack of any disciplined product characterization or dosing studies, and the absence of any product release testing.  


This criticism is not equally levied at all autologous GTP products or companies - even those relying on point-of-care processing.  Of course some companies care and do a lot to try to ensure their product is well-characterized and that each batch complies with product specifications. This may involve the use of product release tests but can also involve the combination of pre-market research into the product characterization, safety, and dosing along with validation of the device/kit output.  In this way a company can say that within a very small margin, the output will be within the product specifications the company knows is safe and efficacious.


However, in a rush to get their device/kit to market some companies appear to care very little about the cell product characterization, validation of the output of their device/kit, or tying this data to optimal dose.


More concerning are those companies that appear to provide such data but it is wrong or meaningless.  What follows appears to potentially be a case study of precisely this problem. 


The INCELL Study 


This week I came across a fascinating white paper from Incell Corporation analyzing the output of adipose tissue processing kits of MediVet-America apparently demonstrating the inaccuracy of their cell counts (a common type of cell therapy product characterization) and calling into the question the cell count claims of Intellicell Biosciences (New York, NY) and Adistem (Hong Kong).


At the heart of the critique is the claim that the cell counting (product characterization) techniques employed by these companies counts as cells things (namely acellular micelles) which are not cells.

I encourage you to read the white paper in its entirety.  They corresponding author told me to watch for one or more papers which they are preparing for submission to peer-reviewed publications shortly.  Presumably these will rely on a larger data set and perhaps test other methodologies or technologies.


For the purposes of this blog, I've pulled what I believe are the most salient excerpts below:

Intrigued by the high cell numbers  (5 to 20 million cells/gram)  reported by kit/device manufacturers such as MediVet-America (Lexington, KY), Intellicell  Biosciences (New York, NY), and Adistem, Ltd. (Hong Kong) in adipose stem cell therapy compared to other methods (e.g., 
Chung,Vidal, and Yoshimura), INCELL staff conducted a research study to  investigate the high apparent yield of stem cells.  This initial work was focused  on SVF cells from the MediVet Kit, which is marketed to isolate adiposederived canine SVF and stem cells.

The cell yields reported for the Medivet Kits are five to more than ten times higher than the yields routinely obtained by INCELL from freshly harvested human or animal adipose tissue using our adipose tissue processing methods.  These yields are also tenfold or higher than those reported in the literature by most academic researchers (Chung-canine, Vidal–equine, Yoshimura–human).  Since these  cell counts are used to support stem cell dosing recommendations and cell banking, it is important to better understand why the cell numbers are higher.

...

A comparative analytical study of three dog donors of adipose tissue was designed to evaluate the cell yields using the MediVet Kit as an example of this class of isolation system. All  kit procedures were followed as per the instructions provided.  A brief overview of the different cell counting methods used, and the resultant cell counts, observations and explanations of the results observed, are described below

....

This study shows that incorrect counting of adipose derived SVF cells and the subset of regenerative stem cells can subsequently result in inaccurate dosing, both in direct therapeutic applications and in cryostorage of cells for future use.  The DAPI-hemocytometer cell count (manual) was considered the most accurate, but there are various sources of technical difficulties that  can lead to incorrect  cell numbers. The nature of adipose tissue itself with variability in dissociation by enzymatic digestion can all contribute to the outcomes. Fat tissue has a propensity to form acellular micelles and oils upon tissue disruption. Processing methods or reagents (e.g., Solution E or lecithins) can generate micelles that may be  erroneously  counted as cells. Autofluorescence and dye trapping or uptake by the micelles can lead to very high inaccurate cell counts when automated cell counting is used. 

In this study the most inaccurate counting came from the Cellometer. When used according to kitrecommended guidelines and on-site training provided by Nexelcom for counting  cells by the MediVet procedure, the Cellometer overstated the DAPI-hemocytometer cell count by up to 20X or more. The Coulter Counter protocols also led to incorrect, high cell numbers. Although the cell counts were still a bit high, the authors recommend the NucleoCounter, or similar equipment, as more acceptable for automated counting.  The manual hemocytometer-DAPI method is the most accurate, but requires a highly experienced cell biologist or technician to make accurate counts and  is not suitable for routine clinical use. 

...

Other companies also have claims of very high cell numbers when their processes are used. Adistem, like MediVet, states they add an emulsifying agent to their kits to assist in cell release, and they also use a light activation system. Their kits were not tested in this study but it is possible that the high cell numbers reported by Adistem are also incorrect and result from the same problems highlighted in this paper for the MediVet procedure. Ultrasonic energy, which is commonly used to manufacture micellular  liposome  structures and to disrupt and lyse cells, is  another potentially problematic procedure for counting and verifying viable, regenerative cells.  Intellicell 3uses ultrasonic energy to release cells from adipose tissue, and it is possible that resultant micelles or cell fragments contribute to the higher than expected cell numbers.  This assumption could be verified with additional studies.  

In summary, the authors caution that great care must be taken when using kits and automated cell counting for stem cell dosing and cryobanking of cells intended for clinical use. Overestimated  cell numbers would be a major confounding source of variation when efficacy of stem cells injected are compared as doses based on cell number and when cryostored cells are aliquoted for use based on 

specific cell numbers as a treatment dose.  Hopefully, this study will lead to more  reproducible counting and processing methods being reported in the literature, more inter-study comparability of cell doses to clinical outcomes,  more industry diligence to support claims, and more accurate counting for dosing stem cell therapies to patients.

...

Chung D, Hayashi K, Toupadakis A, et al.  Osteogenic proliferation and differentiation of canine bone marrow and adipose tissue derived mesenchymal stromal cells and the influence of hypoxia.  Res Vet Sci, 2010; 92(1):66-75. Vidal MA, Kilroy GE, Lopez MJ, Johnson JR, Moore RM, Gimble JM. Characterization of equine adipose tissue-derived stromal cells: adipogenic and osteogenic capacity and comparison with bone marrow-derived mesenchymal stromal cells. Vet Surg, 2007; 36:613–622.  Yoshimura K, Shigeura T, Matsumoto D, et al:  Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirate.  J Cell Phys, 2006; 205:64-76.

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Cell therapies present unique challenges when complying with this paradigm for several reasons only two of which I will mention here.  Firstly, it is not possible to achieve the level of product purification as one might with other therapeutic products.  Secondly, the product characterization is at a cellular rather than molecular level.

Autologous cell therapies present another set of unique challenge in this paradigm because of the notable patient-to-patient variability where the patient is also the donor of the raw material.  This often means there is a wider tolerance of heterogeneity in the product but it still must be within what has been proven to the regulatory agency as a safe and effective range.  


In cases where an autologous cell therapy is centrally manufactured, they are most often subjected to product release testing similar to that described above.  One notable difference, particularly for fresh products, is that the products may be shipped to the clinic and even administered before the full panel of test results are obtained.  This wold be considered highly unusual (if ever acceptable) with other types of products but is tolerated because of the time-sensitivity of these products and their high safety profile.


In the case of autologous cell therapy products produced at the bedside there is often not the same kind of product release discipline.  Often the regulatory agencies deal with the product consistency and specification compliance issue by ensuring that the cell processing device used point-of-care is validated to ensure the cellular product output is always within a specified range shown to be clinically safe and effective.


The Varying Degree of Product Characterization/Specification of Autologous GTP Cell Therapy Products


However - and now I get to the point of this blog post - for cell-based products, procedures and/or devices/kits which are not mandated to be formally approved by a regulatory agency before they can be commercially marketed, there is no product specification rigor.  Compliance with the Good Tissue Practice regulations and guidance is deemed to ensure safety.  In the United States, cell-based products which are deemed to be "minimally manipulated" and intended for "homologous use" are typically allowed to go straight to market with no formal approval.  Safety and clinical data is not required but is practically necessary to support physician adoption and, where applicable, reimbursement.  


This means that for these products there is a great deal of variability in terms of how much rigor companies apply in characterizing their product and then ensuring that each batch complies with the specifications they themselves have determined to be safe and effective. Again, where such products are manufactured in a centralized facility the likelihood of some release testing is greater.  However, those companies relying on a point-of-care processing kit or device business model that has not been deemed to require formal market approval, rarely (if ever) include product release testing.


The common criticism of these companies is that they simply do not know what they are injecting into patients because of the combination of the patient-to-patient donor variability, the lack of any disciplined product characterization or dosing studies, and the absence of any product release testing.  


This criticism is not equally levied at all autologous GTP products or companies - even those relying on point-of-care processing.  Of course some companies care and do a lot to try to ensure their product is well-characterized and that each batch complies with product specifications. This may involve the use of product release tests but can also involve the combination of pre-market research into the product characterization, safety, and dosing along with validation of the device/kit output.  In this way a company can say that within a very small margin, the output will be within the product specifications the company knows is safe and efficacious.


However, in a rush to get their device/kit to market some companies appear to care very little about the cell product characterization, validation of the output of their device/kit, or tying this data to optimal dose.


More concerning are those companies that appear to provide such data but it is wrong or meaningless.  What follows appears to potentially be a case study of precisely this problem. 


The INCELL Study 


This week I came across a fascinating white paper from Incell Corporation analyzing the output of adipose tissue processing kits of MediVet-America apparently demonstrating the inaccuracy of their cell counts (a common type of cell therapy product characterization) and calling into the question the cell count claims of Intellicell Biosciences (New York, NY) and Adistem (Hong Kong).


At the heart of the critique is the claim that the cell counting (product characterization) techniques employed by these companies counts as cells things (namely acellular micelles) which are not cells.

I encourage you to read the white paper in its entirety.  They corresponding author told me to watch for one or more papers which they are preparing for submission to peer-reviewed publications shortly.  Presumably these will rely on a larger data set and perhaps test other methodologies or technologies.


For the purposes of this blog, I've pulled what I believe are the most salient excerpts below:

Intrigued by the high cell numbers  (5 to 20 million cells/gram)  reported by kit/device manufacturers such as MediVet-America (Lexington, KY), Intellicell  Biosciences (New York, NY), and Adistem, Ltd. (Hong Kong) in adipose stem cell therapy compared to other methods (e.g., 
Chung,Vidal, and Yoshimura), INCELL staff conducted a research study to  investigate the high apparent yield of stem cells.  This initial work was focused  on SVF cells from the MediVet Kit, which is marketed to isolate adiposederived canine SVF and stem cells.

The cell yields reported for the Medivet Kits are five to more than ten times higher than the yields routinely obtained by INCELL from freshly harvested human or animal adipose tissue using our adipose tissue processing methods.  These yields are also tenfold or higher than those reported in the literature by most academic researchers (Chung-canine, Vidal–equine, Yoshimura–human).  Since these  cell counts are used to support stem cell dosing recommendations and cell banking, it is important to better understand why the cell numbers are higher.

...

A comparative analytical study of three dog donors of adipose tissue was designed to evaluate the cell yields using the MediVet Kit as an example of this class of isolation system. All  kit procedures were followed as per the instructions provided.  A brief overview of the different cell counting methods used, and the resultant cell counts, observations and explanations of the results observed, are described below

....

This study shows that incorrect counting of adipose derived SVF cells and the subset of regenerative stem cells can subsequently result in inaccurate dosing, both in direct therapeutic applications and in cryostorage of cells for future use.  The DAPI-hemocytometer cell count (manual) was considered the most accurate, but there are various sources of technical difficulties that  can lead to incorrect  cell numbers. The nature of adipose tissue itself with variability in dissociation by enzymatic digestion can all contribute to the outcomes. Fat tissue has a propensity to form acellular micelles and oils upon tissue disruption. Processing methods or reagents (e.g., Solution E or lecithins) can generate micelles that may be  erroneously  counted as cells. Autofluorescence and dye trapping or uptake by the micelles can lead to very high inaccurate cell counts when automated cell counting is used. 

In this study the most inaccurate counting came from the Cellometer. When used according to kitrecommended guidelines and on-site training provided by Nexelcom for counting  cells by the MediVet procedure, the Cellometer overstated the DAPI-hemocytometer cell count by up to 20X or more. The Coulter Counter protocols also led to incorrect, high cell numbers. Although the cell counts were still a bit high, the authors recommend the NucleoCounter, or similar equipment, as more acceptable for automated counting.  The manual hemocytometer-DAPI method is the most accurate, but requires a highly experienced cell biologist or technician to make accurate counts and  is not suitable for routine clinical use. 

...

Other companies also have claims of very high cell numbers when their processes are used. Adistem, like MediVet, states they add an emulsifying agent to their kits to assist in cell release, and they also use a light activation system. Their kits were not tested in this study but it is possible that the high cell numbers reported by Adistem are also incorrect and result from the same problems highlighted in this paper for the MediVet procedure. Ultrasonic energy, which is commonly used to manufacture micellular  liposome  structures and to disrupt and lyse cells, is  another potentially problematic procedure for counting and verifying viable, regenerative cells.  Intellicell 3uses ultrasonic energy to release cells from adipose tissue, and it is possible that resultant micelles or cell fragments contribute to the higher than expected cell numbers.  This assumption could be verified with additional studies.  

In summary, the authors caution that great care must be taken when using kits and automated cell counting for stem cell dosing and cryobanking of cells intended for clinical use. Overestimated  cell numbers would be a major confounding source of variation when efficacy of stem cells injected are compared as doses based on cell number and when cryostored cells are aliquoted for use based on 

specific cell numbers as a treatment dose.  Hopefully, this study will lead to more  reproducible counting and processing methods being reported in the literature, more inter-study comparability of cell doses to clinical outcomes,  more industry diligence to support claims, and more accurate counting for dosing stem cell therapies to patients.

...

Chung D, Hayashi K, Toupadakis A, et al.  Osteogenic proliferation and differentiation of canine bone marrow and adipose tissue derived mesenchymal stromal cells and the influence of hypoxia.  Res Vet Sci, 2010; 92(1):66-75. Vidal MA, Kilroy GE, Lopez MJ, Johnson JR, Moore RM, Gimble JM. Characterization of equine adipose tissue-derived stromal cells: adipogenic and osteogenic capacity and comparison with bone marrow-derived mesenchymal stromal cells. Vet Surg, 2007; 36:613–622.  Yoshimura K, Shigeura T, Matsumoto D, et al:  Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirate.  J Cell Phys, 2006; 205:64-76.

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CLEARWATER, FL--(Marketwire -08/28/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, The Company), a fully reporting public company in the stem cell regenerative medicine sector, announced today that, in response to overwhelming inquiries from hair clinics around the nation, it has completed preparation to allow for expansion of hair regrowth services throughout the United States.

According to Dwight Brunoehler, Chief Executive Officer of Bisotem, "On the heels of Dr. Marina Pizarro's initial hair replacement procedures using The Biostem Method, the Company is now fully prepared to offer and support turnkey operations that will provide its proprietary hair regrowth technology to qualified physicians and clinics in the U.S. This service provides equipment, on site set up, training, operational protocols, marketing assistance, a fully staffed training facility, and on-going support. Our intention is to make this as easy as possible for affiliates to become involved. After entering into an agreement, physicians will be able to offer Biostem services in their offices within 8 weeks. It is expected that hair replacement clinics in New York, California, Texas and other metropolitan centers known for the popularity of cosmetic procedures will be on board The Biostem Method before the end of the year."

Biostem U.S., Corporation has developed a hair restoration process known as The Biostem Method. This process, offered through Biostem affiliates and licensees, involves the use of platelet rich plasma injections, low level laser therapy, nutraceutical supplements to stimulate stem cell growth, and private labeled hair products. This combination has proven highly effective in restoring hair growth in men and women.

About Biostem U.S., CorporationBiostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on providing hair regrowth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Fox Communications Group, 310-974-6821.

Read the original:
Biostem U.S., Corporation Opens National Affiliate Program for The Biostem Method(TM) of Hair Regrowth Treatments

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT)(ACTC), a leader in the field of regenerative medicine, today issued a statement on the U.S. Appeals Courts ruling, upholding a lower courts dismissal of the case, Sherley v. Sebelius, 11-5241, U.S. Court of Appeals for the District of Columbia Circuit (Washington), on the permissibility of federal funding of embryonic stem cell research.

This court ruling should be of considerable benefit to ACT and our embryonic stem cell-based clinical programs, commented Gary Rabin, chairman and CEO. It effectively removes major speed bumps for the National Institutes of Health (NIH) in terms of approving the several stem cell lines that we have submitted for their consideration for funding. With Fridays decisive ruling, we expect that a number of our embryonic stem cell lines will be approved for funding in coming months.

Sherley v. Sebelius had sought to block the United States Health and Human Services Department and the NIH from spending federal funds for research with hESCs, contending that doing so would violate the Dickey-Wicker Amendment, a short rider attached to legislation passed in 1996.

This ruling removes a great deal of the ambiguity that has hampered legislative attempts to provide an efficient mechanism for federal funding of hESC research, continued Mr. Rabin. The path for legislators to enact such legislation has now been cleared, and in that case we are optimistic that there could be encouraging new developments in the legislative arena, as well, in coming months. We would certainly hope that our patented, proprietary embryo-safe single-cell blastomere technique would be a part of any such conversation. We feel that if we could educate more Americans about this technique, and how directly and effectively it addresses the various ethical objections to hESC research, that broad support for the technique and the field overall would quickly fall into place.

More commentary on Fridays court ruling will be posted today on Mr. RabinsChairmans blog.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

Continued here:
ACT Comments on U.S. Appeals’ Court’s Dismissal Ruling in Case Challenging Federal Funding of Embryonic Stem Cell ...

TORONTO, ON Stem cells hold great promise for treating and curing numerous diseases; however, a major challenge facing scientists is how to produce stem cells in the massive quantities required for clinical use. The McEwen Centre for Regenerative Medicine (McEwen Centre) and the University of Toronto-based Centre for Commercialization of Regenerative Medicine (CCRM) are partnering to establish a fund that will drive research in this area. Several University of Toronto regenerative medicine scientists are affiliated with CCRM and the Scientific Director is Dr. Peter Zandstra of the Institute of Biomaterials and Biomedical Engineering.

The McEwen Centre-CCRM Commercialization Impact Prize launches today, and will solicit innovative ideas from regenerative medicine scientists working in labs throughout the McEwen Centre. The winning team(s) will be awarded up to $600,000 to pursue research that will determine how to manufacture stem cells for clinical use and drug screening.

This private-public funding partnership is an important step forward to accelerating the advance of a discovery from a lab bench to the patient and onto the global market. Scientists at the McEwen Centre are making significant progress towards finding a cure for diseases such as Type 1 diabetes and heart disease. Collaborative partnerships are the key to discovering the cures sooner! says Rob McEwen, co-founder of the McEwen Centre, and Chief Owner, McEwen Mining.

Deadline for submissions is October 15, 2012. The Prize will fund up to two, 2-year projects that address the following challenges:

Making the transition from pre-clinical to clinical mass production; and, Scaling up stem cell manufacturing for high throughput drug screening.

Overcoming the scale-up and manufacturing challenge of stem cells would be a huge advancement for the regenerative medicine [RM] industry and this initiative fits in perfectly with our mandate to bridge the RM commercialization gap, explains Dr. Michael May, CEO of the Centre for Commercialization of Regenerative Medicine. Were very pleased to be working with the McEwen Centre, already a partner of ours, to make this happen.

The Commercialization Impact Prize budget template and application form can be found here: http://ccrm.ca/Commercialization-Impact-Prize or http://mcewencentre.com/ccrm

About McEwen Centre for Regenerative Medicine The McEwen Centre for Regenerative Medicine was founded by Rob and Cheryl McEwen in 2003 and opened its doors in 2006. The McEwen Centre for Regenerative Medicine, part of Toronto-based University Health Network, is a world leading centre for stem cell research, facilitating collaboration between renowned scientists from 5 major hospitals in Toronto, the University of Toronto and around the world. Supported by philanthropic contributions and research grants, McEwen Centre scientists strive to introduce novel regenerative therapies for debilitating and life threatening illnesses including heart disease, spinal cord injury, diabetes, diseases of the blood, liver and arthritis.

About Centre for Commercialization of Regenerative Medicine (CCRM) CCRM, a Canadian not-for-profit organization funded by the Government of Canadas Networks of Centres of Excellence program and six institutional partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM translates scientific discoveries into marketable products for patients. CCRM launched in Torontos Discovery District on June 14, 2011.

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New partnership to drive mass production of life-saving stem cells - Commercialization Impact Prize is first of its ...

Advanced Cell Technology Inc.Posted on:20 Aug 12

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that Scotlands NHS Lothian has been confirmed as a site for its Phase I/II human clinical trial for Stargardts Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

NHS Lothian should be a superb partner for our EU clinical trial for SMD, said Gary Rabin, chairman and CEO of ACT. We are particularly pleased to be working with the Principal Investigator, Professor BaljeanDhillon, and his team. Additionally, we would like to thank the men and women of the Scottish Development Authority and Scottish National Blood Transfusion Service (SNBTS) for their tireless efforts to help make this history-making clinical trial a reality.

This approved, Phase I/II clinical trial for SMD is a prospective, open-label study designed to determine the safety and tolerability of RPE cells derived from hESCs following sub-retinal transplantation to patients with advanced SMD. It is similar in design to the companys US trials for SMD and dry age-related macular degeneration initiated in July 2011.

SMD represents an important unmet need in the wider clinical arena of macular degeneration, said Professor Dhillon, BMed Sci, BM BS, FRCS, Consultant Ophthalmic Surgeon, at the Princess Alexandra Eye Pavilion, NHS Lothian andHonorary Professor of Ophthalmology at the University of Edinburgh. This trial will evaluate a promising potential new treatment for this condition, using hESC-derived RPE cells.

Professor Marc Turner, Medical Director of SNBTS continued, hESC-derived RPE cells represent one of the first of a new generation of regenerative therapies and is an example of the high quality clinical research being conducted in, and supported by, NHS Scotland which we hope will help to transform medicine over the coming decades.

On July 30, the company announced that the third patient in this SMD clinical trial had been treated.

More information on the companys clinical trials will be posted today on Mr. RabinsChairmans blog.

About Stargardts Disease

Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

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Press Release

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that Scotlands NHS Lothian has been confirmed as a site for its Phase I/II human clinical trial for Stargardts Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

NHS Lothian should be a superb partner for our EU clinical trial for SMD, said Gary Rabin, chairman and CEO of ACT. We are particularly pleased to be working with the Principal Investigator, Professor BaljeanDhillon, and his team. Additionally, we would like to thank the men and women of the Scottish Development Authority and Scottish National Blood Transfusion Service (SNBTS) for their tireless efforts to help make this history-making clinical trial a reality.

This approved, Phase I/II clinical trial for SMD is a prospective, open-label study designed to determine the safety and tolerability of RPE cells derived from hESCs following sub-retinal transplantation to patients with advanced SMD. It is similar in design to the companys US trials for SMD and dry age-related macular degeneration initiated in July 2011.

SMD represents an important unmet need in the wider clinical arena of macular degeneration, said Professor Dhillon, BMed Sci, BM BS, FRCS, Consultant Ophthalmic Surgeon, at the Princess Alexandra Eye Pavilion, NHS Lothian and Honorary Professor of Ophthalmology at the University of Edinburgh. This trial will evaluate a promising potential new treatment for this condition, using hESC-derived RPE cells.

Professor Marc Turner, Medical Director of SNBTS continued, hESC-derived RPE cells represent one of the first of a new generation of regenerative therapies and is an example of the high quality clinical research being conducted in, and supported by, NHS Scotland which we hope will help to transform medicine over the coming decades.

On July 30, the company announced that the third patient in this SMD clinical trial had been treated.

More information on the companys clinical trials will be posted today on Mr. RabinsChairmans blog.

About Stargardts Disease

Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

Excerpt from:
ACT Announces Scotland’s NHS Lothian as Additional Site for EU Clinical Trial Using hESC-Derived RPE Cells for Macular ...

BACKGROUND: According to the U.S. Department of Health and Human Services, regenerative medicine is the next evolution of medical treatments. Regenerative medicine offers the potential for the body to heal itself. Scientists at the Wake Forest Institute for Regenerative Medicine in Winston-Salem, N.C., were the first in the world to engineer lab-grown organs that were successfully implanted into humans. Now, the team of researchers is working to engineer more than 30 different replacement tissues and organs to develop cell therapies with the goal of curing a variety of diseases. (SOURCE: Wake Forest Institute for Regenerative Medicine)

LAB-GROWN URETHRAS: Researchers from Wake Forest were the first in the world to use patients own cells to build tailor-made urine tubes in the lab and successfully replace damaged tissue in five boys in Mexico. The boys were unable to urinate due to a pelvic injury. After receiving the lab-grown urethras, all the boys continue to do well with normal or near-normal urinary flow. The urethras were grown on biodegradable mesh scaffolds made of a polyester compound. The scaffolds were seeded with cells taken from the patients own bladders and incubated in the lab for four to seven weeks. They were then used to repair damaged segments of the boys urethras. For us, really, our goal here at the Institute is really to try to complete technologies that we can get to patients to make their lives better, so anytime that were able to do that, improve the quality of patients lives, we feel like thats part of our mission, Anthony Atala, M.D., Director, Wake Forest Institute for Regenerative Medicine, told Ivanhoe.

(SOURCE: Ivanhoe interview with Dr. Atala and WebMD article)

GROWING EARS: Scientists are working on printing ears in the lab. What we can do is we can take any three dimensional image of an ear, and it can be put into the computer, and that will generate an image within the printer that then prints that specific three dimensional structure, John Jackson, Ph.D., Associate Professor, Wake Forest Institute for Regenerative Medicine, told Ivanhoe. Right now, implants that are commercially-available are hard and rigid. They also cause problems with erosion through the skin. The new, tailor-made ears are flexible and patient-specific. In animal studies, the lab-grown ears have been shown to cause less erosion. The next step is to print the ears for use in humans. To be able to take a structure, generate a 3D implant and have that as a potential treatment for a patient who has lost an ear, thats very exciting, Dr. Jackson told Ivanhoe.

(SOURCE: Ivanhoe interview with Dr. Jackson)

ENGINEERING MUSCLE: Researchers are also looking to see if they can engineer tissue that resembles muscle to repair small injuries in the body. They take biopsies from skeletal muscles and culture out the stem cells from the muscle. They then seed the cells onto a scaffold and condition the scaffold and a bioreactor to exercise muscle in-vitro. Then, they use that construct as an implant to accelerate regeneration and repair of injured muscle in the body. Scientists have been studying the engineered muscle in animals, and the next step is to try it in humans. For me, personally, its fantastic because you dont often get an opportunity to do research thats not only compelling but that can result in therapies that can help people on a daily basis and really improve their quality of life, George Christ, Ph.D., Professor of Regenerative Medicine, Wake Forest Institute for Regenerative Medicine, told Ivanhoe.

(SOURCE: Ivanhoe interview with Dr. Christ)

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Building Body Parts: Ears, Muscles and More!

CLEARWATER, FL--(Marketwire -08/13/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company) is a fully reporting public company in the stem cell regenerative medicine sciences sector. President, John Satino announced today that the Pizarro Hair Restoration Clinic in Orlando, Florida is now equipped and ready to begin offering The Biostem Method of hair re-growth using the patient's own adult cells in a minimally invasive, painless procedure. In addition, Biostem Medical Director and Trainer, Dr. Marina Pizarro is ready to offer onsite training to new Biostem affiliates.

According to Satino, "This week, Dr. Pizarro treated her first two patients using The Biostem Method of hair re-growth in her Orlando office. This paves the way for Biostem to start offering affiliate agreements throughout the country in response to the many inquiries from physicians who want to offer this transplant alternative to their patients. We are making plans to open affiliate offices in major cities soon, after which we will expand the services to rural and international locations focusing first on Europe and Asia."

As a side note, Satino stated that, "While the industry typically sees more males requesting hair transplant for hair re-growth solutions, it is interesting that the first two treatments Dr. Pizarro performed were on women. Statistics do show that women suffer hair loss in significant numbers, yet are less likely to go through the transplant procedure. The Biostem Method finally offers women as well as men, a viable and proven alternative."

About Biostem U.S. Corporation Biostem U.S., Corporation (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

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Biostem Medical Director, Dr. Marina Pizarro Performs First Biostem Method(TM) of Hair Re-Growth Procedures at Orlando ...

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CLEARWATER, FL--(Marketwire -08/07/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announced the appointment of Marina Pizarro, M.D. to its Scientific and Medical Board of Advisors (SAMBA). Chief Executive Officer Dwight Brunoehler stated, "The addition of Dr. Pizarro to Scientific and Medical Board of Advisors rounds out our team with expertise in the field of hair re-growth using stem cells. We look forward to her interaction with the members to help advance the Company's mission to improve the quality and longevity of life for all mankind through the use of ethically sourced stem cells."

Dr. Pizarro is currently the Medical Director for Biostem U.S. as well as their trainer for the Company's hair re-growth Affiliate Program. As the company accepts qualified affiliate physicians to administer The Biostem Method of hair re-growth throughout the United States, Dr. Pizarro will oversee their training at her Orlando, Florida location, where she is currently accepting patients. Dr. Pizarro will begin offering the Biostem Method in her Tampa and Jacksonville, Florida offices in the coming months. She will also assist in overseeing the set-up of another training facility overseas as the company expands its Medical Affiliate Program internationally.

Dr. Marina Pizarro holds the distinction of being the first female hair transplant physician in the industry and belongs to the elite group of surgeons who have performed over 30,000 hair transplant procedures in their careers. She received her medical degree from Ponce School of Medicine in Puerto Rico in 1985. After completing her residency in Orlando, Dr. Pizarro worked with world renowned hair transplant surgeon Dr. Constantine Chambers building one of the largest hair restoration practices in history. After five years, and after having performed thousands of procedures around the world while lecturing at hair restoration conventions, Dr. Pizarro opened her first two facilities in Orlando and Jacksonville, Florida in 1994, specializing in hair transplantation for both men and women. She currently has three facilities in Florida with the addition of her clinic in Tampa. Dr. Pizarro is a member of The International Society of Hair Restoration Surgery and the European Society of Hair Restoration Surgery.

About Biostem U.S. Corporation

Biostem U.S., Corporation (HAIR) (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

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Biostem U.S., Corporation Appoints Marina Pizarro, M.D. to Scientific and Medical Board of Advisors (SAMBA)

HOUSTON, Aug. 2, 2012 /PRNewswire/ --Celltex Therapeutics Corporation, a leader in regenerative medicine services, today announced the appointments of Andrea Ferrenz, Executive Vice President, Legal Counsel, and Jane Shen Young, Manufacturing Research Scientist. Ferrenz's primary responsibility will be overseeing operations, including compliance with federal and state regulatory agencies. Young's primary responsibility will be research and development of manufacturing processes and products in regenerative science.

"Celltex is a fast growing company. The additions of Andrea and Jane will enhance our capabilities as we continue to grow," said David Eller, Chief Executive Officer of Celltex. "At Celltex, we firmly believe in the great therapeutic potential for adult stem cells and we are committed to the highest quality banking and multiplication services for clients and physicians."

Ferrenz has more than 15 years of experience in regulatory compliance and litigation, with expertise in food, drug and health law. Prior to Celltex, Ferrenz was Principal Attorney at Emord & Associates, P.C., in Washington, D.C.There, she counseled both national and international clients in health products industries operating under the jurisdiction of the FDA and FTC.Early in her career, Ferrenz worked with the U.S. Department of Health and Human Services and Children's National Medical Center's Center for Cancer and Transplantation Biology.

Ferrenz received her Bachelor's degree in biology from University of Mary Washington in Fredericksburg, Virginia, and her juris doctorate from George Washington University Law School in Washington, D.C.

"As a pioneer in stem cell banking, Celltex is paving the way for this new frontier," said Ferrenz."I hope my background in health and FDA law will be an asset to Celltex and I look forward to helping Celltex grow while maintaining positive relationships with government regulators who work to ensure the safety of health products."

Young joins Celltex from Pharmaceutical Product Development, Inc. in Middleton, Wisconsin, where she served as Associate Research Scientist. Formerly an Internal physician in the Department of Medicine at Wang-Jiang-Shan Hospital in Zhejiang, China, and a Visiting Scientist and Ph.D. in molecular biology and biochemistry at the Lund University, Sweden, Young has expertise in cell biology, molecular genetics and biochemistry. She has also co-authored publications on the development and optimization of laboratory assays, and cell sort and flow cytometry analysis.

Young received her medical degree from Zhejiang University School of Medicine. Zhejiang, China. She received her doctoral degree from Lund University, Faculty of Medicine in Sweden.

"Stem cell banking is cutting edge technology in a field that holds great potential," noted Young. "Quality and safety are tantamount to the growth of this industry and I am excited to help Celltex provide stem cell banking and multiplication of the highest quality to its clients."

For more information on Celltex Therapeutics Corporation and its staff please visit http://www.CelltexBank.com.

About Celltex

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Celltex Therapeutics Corporation Expands Laboratory Operations And Adds Depth To Its Management Team

CLEARWATER, FL--(Marketwire -08/02/12)- Biostem U.S., Corporation, (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, Chief Executive Officer Dwight Brunoehler stated, "Dr. Prendergast is a very talented and very active clinical and research surgeon. Biostem is fortunate to have his guidance in our scientific and medical pursuits. He will be playing an ever increasingly important role in the company's future regarding the use of stem cells and regenerative medicine."

According to Dr. Prendergast, "The Robert Wood Johnson Medical School currently has several stem cell related projects including the use of stem cells to reduce the risk of kidney related dysfunction following cardiac surgery. As Biostem grows, I look forward to assisting in implementing the Company's stem cell regenerative medicine goals in multiple areas."

Dr. Prendergast is a clinical cardiothoracic surgeon, who performs 200-250 open-heart operations and 5 to 15 heart transplants each year. He is deeply involved in numerous clinical and research activities associated with stem cells and heart repair. He is presently Director of Cardiac Transplantation at Robert Wood Johnson University Hospital in New Brunswick, New Jersey, where he holds an Associate Professorship of Surgery at the University of Medicine and Dentistry of New Jersey. In addition to being an active participant in stem cell research program development and teaching medical students and residents, his other interests include medical research funding and humanitarian development of programs for Disabled American Veterans.

Dr. Prendergast received his undergraduate degrees in biophysics and psychology, as well as his medical degree, at Pennsylvania State University. His general surgery residency was for five years at the University of Massachusetts Medical School. His cardiothoracic surgery training was at the University of Southern California School of Medicine, including the Los Angeles County Medical Center. Subsequent fellowship training included pediatric cardiac surgery at Children's Hospital Los Angeles, along with thoracic transplant fellowships at University of Southern California in Los Angeles and at Temple University Hospital in Philadelphia. He spent three years at the University of Kansas establishing thoracic transplant programs until returning to Temple University Hospital as one of their staff heart and lung transplant surgeons. Subsequent to his time at Temple, he joined up with Newark Beth Israel/St. Barnabas Hospitals, where he assumed directorship as the Chief of Cardiac Transplantation and Mechanical Assistance.

About Biostem U.S. Corporation

Biostem U.S., Corporation (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

For further information on Biostem U.S. Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

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Biostem U.S., Corporation Scientific and Medical Board of Advisors Member Appointed Chief of Cardiothoracic Surgery at ...

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the final patient in the first patient cohort in its Phase 1/2 clinical trial for Stargardts macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Friday, July 27 at Moorfields Eye Hospital in London, the same site as the first two treatments, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London. The outpatient transplant surgery was performed successfully without any complications, and the patient is recovering uneventfully. This is the tenth patient overall to now be treated with the RPE cell therapy developed by the company.

Our European trial is making very steady progress, having now completed enrollment of the first patient cohort, commented Gary Rabin, chairman and CEO. We are very encouraged and look forward to receiving clearance to initiate the treatment of the second patient cohort in the coming weeks.

The Phase 1/2 trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the studys primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format. It is similar in design to the U.S. trial for SMD that was initiated in July 2011.

This is a significant month for the company, continued Mr. Rabin. One year ago we treated the first of our patients in our two U.S. clinical trials. The one-year follow-up for those initial patients indicates that the improvements in visual acuity we initially reported have in fact persisted now for a year. Indeed, we are consistently observing improvements in subjective and objective visual acuity for patients being treated at the various clinical centers involved in our trials. Again, these trials are still at very early stages, but these preliminary results indicate that we are on the right track.

The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has officially designated ACT's human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells as an orphan medicinal product for the treatment of SMD.

About Stargardts Disease

Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

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ACT Treats 10th Patient in Embryonic Stem Cell Trials for Macular Degeneration

As followers of this blog will know I've been blogging about Regenerative Sciences and predicting their eventual run-in with the FDA since my first post in September 2008 (Cell Therapy is Not the Practice of Medicine) and again in February 2009 (Regenexx vs the FDA 2009).  When the FDA finally proceeded with an injunction against RSI in August 2010,I helped spread the news (here).

I've watched the development of the fight between RSI and the FDA with interest.  In September 2001 I posted a rather lengthy commentary about the potential impact of the case (Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy.

Since then I have welcomed other bloggers and commentators who are now following and commenting on the case much more closely and frequently than I including @LeighGTurner (on Twitter) and Paul Knoepfler (@PKnoepfler on Twitter and his Knoeplfer Lab Stem Cell Blog).  Recently I enjoyed being interviewed by Paul on the issue of unregulated stem cell activity and touched on the case for his blog.

Consequently I read with interest yesterday's federal court ruling upholding the FDA's injunction against RSI and the immediate commentary from the New Scientist, Stanford's Scope Blog and Knopfler's multiple posts (here and here). As a long-term follower of this case, I've been asked to comment.  Here is my brief reaction:

This is a case that was always destined for the appellate courts regardless of which way the initial court ruled.    The fact the federal court ruled in the FDA's favor certainly now sets the onus on RSI and what is anticipated to be a gamut of intervenors but taking this case to the appellate courts is what the legal team have anticipated and legal arguments designed for all along.

This is just the beginning of what will be a long and interesting battle.  The ruling was nothing more than the granting of an injunction in response to the government's motion for summary judgement.  In granting the injunction the court  agreed with the government's position that it was acting under the authority given it under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) but it provided little-to-no rationale for its ruling.

The court chose, in its wisdom, not to address the bulk of the RSI's legal arguments which are largely jurisdictional in nature. These are the kinds of arguments which the lower courts prefer be dealt with by appellate courts and frankly the judge did us all a favor by ruling quickly, succinctly and punting the case where we all knew it was inevitably headed.

In my opinion, other than chalking one up in the government's win column there is little to be gleaned from this ruling in terms of how RSI's arguments will be received in appellate court.  The interesting day is yet to come.

In terms of a short-term practical impact, frankly I see very little.  RSI has already ceased distributing Regenexx within the US so there will be little-to-no impact there.  As for the potential impact on other companies or clinics who might be operating on the fringes of FDA regulation within the US, I suspect it will be business as usual.

Most of the clinics/companies offering cell-based treatments/products which are arguably in contravention of FDA regulation are operating under the clear knowledge of what they are doing and where the FDA stands with respect to the treatments/products they offer and yet they persist and continue.


 For the truly fraudulent there is the risk of criminal charges and/or litigation but for those companies or practitioners who are operating in this shade of grey which are not shady (and they do exist), the  risks associated with this practice are barely higher than in the routine practice of medicine. 


In reality, with the exception of the most fraudulent examples, it takes a fair long-time for the FDA to catch up with these folks and there is good money to be made in the interim.  When they get caught, they will stop. If they've recouped their initial investment (which is nominal and the margins are high) there is very little penalty to this course of action.  Perhaps they set up shot elsewhere or simply enjoy the proceeds.  I doubt we will see much of a slow-down of this kind of activity.  Indeed it may strengthen the resolve of those committed to the cause.

In my opinion yesterday's ruling was in interesting and important milestone in a continuing evolution in the debate of how best to regulate the use of cells in treating people but I'm not sure it's the seminal pivot point that some believe.  I suspect we will not see any radical shift in terms of FDA or industry activity until (if then) the appellate courts rule.

Just my two cents....

--Lee

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As followers of this blog will know I've been blogging about Regenerative Sciences and predicting their eventual run-in with the FDA since my first post in September 2008 (Cell Therapy is Not the Practice of Medicine) and again in February 2009 (Regenexx vs the FDA 2009).  When the FDA finally proceeded with an injunction against RSI in August 2010,I helped spread the news (here).

I've watched the development of the fight between RSI and the FDA with interest.  In September 2001 I posted a rather lengthy commentary about the potential impact of the case (Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy.

Since then I have welcomed other bloggers and commentators who are now following and commenting on the case much more closely and frequently than I including @LeighGTurner (on Twitter) and Paul Knoepfler (@PKnoepfler on Twitter and his Knoeplfer Lab Stem Cell Blog).  Recently I enjoyed being interviewed by Paul on the issue of unregulated stem cell activity and touched on the case for his blog.

Consequently I read with interest yesterday's federal court ruling upholding the FDA's injunction against RSI and the immediate commentary from the New Scientist, Stanford's Scope Blog and Knopfler's multiple posts (here and here). As a long-term follower of this case, I've been asked to comment.  Here is my brief reaction:

This is a case that was always destined for the appellate courts regardless of which way the initial court ruled.    The fact the federal court ruled in the FDA's favor certainly now sets the onus on RSI and what is anticipated to be a gamut of intervenors but taking this case to the appellate courts is what the legal team have anticipated and legal arguments designed for all along.

This is just the beginning of what will be a long and interesting battle.  The ruling was nothing more than the granting of an injunction in response to the government's motion for summary judgement.  In granting the injunction the court  agreed with the government's position that it was acting under the authority given it under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) but it provided little-to-no rationale for its ruling.

The court chose, in its wisdom, not to address the bulk of the RSI's legal arguments which are largely jurisdictional in nature. These are the kinds of arguments which the lower courts prefer be dealt with by appellate courts and frankly the judge did us all a favor by ruling quickly, succinctly and punting the case where we all knew it was inevitably headed.

In my opinion, other than chalking one up in the government's win column there is little to be gleaned from this ruling in terms of how RSI's arguments will be received in appellate court.  The interesting day is yet to come.

In terms of a short-term practical impact, frankly I see very little.  RSI has already ceased distributing Regenexx within the US so there will be little-to-no impact there.  As for the potential impact on other companies or clinics who might be operating on the fringes of FDA regulation within the US, I suspect it will be business as usual.

Most of the clinics/companies offering cell-based treatments/products which are arguably in contravention of FDA regulation are operating under the clear knowledge of what they are doing and where the FDA stands with respect to the treatments/products they offer and yet they persist and continue.


 For the truly fraudulent there is the risk of criminal charges and/or litigation but for those companies or practitioners who are operating in this shade of grey which are not shady (and they do exist), the  risks associated with this practice are barely higher than in the routine practice of medicine. 


In reality, with the exception of the most fraudulent examples, it takes a fair long-time for the FDA to catch up with these folks and there is good money to be made in the interim.  When they get caught, they will stop. If they've recouped their initial investment (which is nominal and the margins are high) there is very little penalty to this course of action.  Perhaps they set up shot elsewhere or simply enjoy the proceeds.  I doubt we will see much of a slow-down of this kind of activity.  Indeed it may strengthen the resolve of those committed to the cause.

In my opinion yesterday's ruling was in interesting and important milestone in a continuing evolution in the debate of how best to regulate the use of cells in treating people but I'm not sure it's the seminal pivot point that some believe.  I suspect we will not see any radical shift in terms of FDA or industry activity until (if then) the appellate courts rule.

Just my two cents....

--Lee

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it has been issued a patent in Australia, patent number 2005325753, Improved modalities for the treatment of degenerative diseases of the retina. The patent broadly covers the use of human retinal pigment epithelial (RPE) cells generated from pluripotent stem cells in the manufacture of pharmaceutical preparations of RPE cells, and the use of those preparations to treat patients with degenerative diseases of the retina such as Age-related Macular Degeneration. The patent covers the pharmaceutical formulation of human RPE cells made from a range of pluripotent stem cells, including both human embryonic stem cells (hESCs) and human induced pluripotent stem (iPS) cells.

We continue to make great progress with our patent estate covering RPE therapies, said Gary Rabin, chairman and CEO of ACT. Our ongoing success in securing broad patent protection around the world, including this newly-issued Australian patent, is a testament to our innovative chief scientific officer, Dr. Robert Lanza, and the rest of our scientific team.

The efficient production of highly pure RPE cell preparations represents a critical step in the creation of renewable sources of transplantable cells that can be used to target degenerative diseases of the eye such as Stargardts Macular Dystrophy (SMD) and dry Age-related Macular Degeneration (dry AMD).

Our current embryonic stem cell trials pave the way for other pluripotent stem cell therapies, commented Dr. Lanza. ACTs cellular reprogramming technologies using iPS cells are in an advanced stage of development, and we hope to be in a position to move toward clinical translation in the not-too-distant future. Since iPS cells can be made from the patients own cells such as skin or blood cells they may allow us to expand our cell therapies beyond immune-privileged sites such as the eye without the risk of immune rejection.

Mr. Rabin concluded, We are aggressively pursuing patent protection for a variety of aspects of our programs. Our intellectual property strategy includes both vigilance in pursuing comprehensive coverage from our initial patent filings, such as this new Australian patent, and filing for protection around our scientific teams various innovations. At the same time we are paying close attention to including within our patent coverage those ways others may wish to adapt our technology for commercial use, such as through the choice of stem cell source, or the use of solid supports or cell suspensions for delivery. Following this strategy, we are establishing both formidable barriers-to-entry for potential competitors, as well as strong potential licensing opportunities for others, translating into solid revenue generation possibilities for the company.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

See the original post:
ACT Issued Broad Patent for Human RPE Cells Derived From All Types of Pluripotent Stem Cells