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Nanotechnology in Medicine and The Environment – Michael J. Sailor

§ October 11th, 2011 § Filed under Nano Medicine Comments Off on Nanotechnology in Medicine and The Environment – Michael J. Sailor

Nanotechnology in Medicine and The Environment Professor Michael J. Sailor UC San Diego Department of Chemistry and Biochemistry COSMOS Discovery Lecture 2011

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Nanotechnology in Medicine and The Environment - Michael J. Sailor

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International Stem Cell Corp. Chairman Kenneth Aldrich Comments on Recent TIME Article “A Stem Cell First: Using the ‘Dolly’ Method on Human Cells”

§ October 9th, 2011 § Filed under Nano Medicine Comments Off on International Stem Cell Corp. Chairman Kenneth Aldrich Comments on Recent TIME Article “A Stem Cell First: Using the ‘Dolly’ Method on Human Cells”

“Since we at International Stem Cell Corporation (trading symbol: ISCO.OB) are licensees of some of the key intellectual property necessary to use SCNT in therapeutic products, we were delighted to read about this new discovery.  However, what disappointed us somewhat was the failure of most news reports to mention that a technology already exists that solves the same ethical problems and has the potential also to solve many of the problems of immune rejection that worry scientists who are working with cells obtained from fertilized embryos.
That technology is called "Parthenogenesis" and results in a "cell line" that can provide an essentially unlimited supply of human cells for a wide range of therapeutic purposes, yet does not involve the destruction of any fertilized embryo and results in cells that can be matched to large groups of people who may not even know the patient, much like the way blood from donors can be stored and used by accident victims as needed. Unlike the SCNT cells, parthenogenetic cells require no genetic manipulation or insertion of foreign DNA.
Our scientists at ISCO created and patented the process for making such human parthenogenetic stem cell lines and have already successfully made liver cells, cornea cells, retina cells and nerve cells from those cell lines.  Each of these applications is being studied as a possible future source of transplanted cells to treat diseases such as Parkinson's, Liver Disease, Macular Degeneration, and others. 
To learn more about parthenogenesis, visit our website at http://www.internationalstemcell.com or click on ISCO.OB at any financial web site for information about our company.”
Kenneth C. Aldrich
Chairman
International Stem Cell Corporation
TIME Article – A Stem Cell First: Using the 'Dolly' Method on Human Cells
http://healthland.time.com/2011/10/05/a-stem-cell-first-using-the-dolly-method-on-human-cells/
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link:http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0 .
Forward-looking Statements
Statements pertaining to anticipated developments, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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International Stem Cell Names Dr. Andrey Semechkin as Co-Chairman and Kurt May as President and Chief Operating Officer

§ October 9th, 2011 § Filed under Nano Medicine Comments Off on International Stem Cell Names Dr. Andrey Semechkin as Co-Chairman and Kurt May as President and Chief Operating Officer

International Stem Cell Corporation (OTCBB:ISCO) today announced that its Board of Directors designated Dr. Andrey Semechkin, the Company's Chief Executive Officer, as a Co-Chairman with the Company's founder, Kenneth Aldrich, and also named Kurt May as President and Chief Operating Officer, effective immediately. Mr. May is currently Senior Vice President and this represents both a promotion and the delegation of additional duties and responsibilities consistent with his increasingly important role in the future of ISCO.
Dr. Semechkin commented, "Kurt May is an extremely capable executive who has managed both a multi-billion dollar public company and a successful life sciences startup company. His willingness to assume operational responsibilities for ISCO will allow me, as CEO, to focus more intently on scientific and strategic initiatives that are central to developing ISCO into a major force in the world of stem cell therapy. Working together with the fine team of executives and scientists already within ISCO, I have high hopes and confidence we can reach that goal."
Prior to joining ISCO, Mr. May was a senior executive with GTE Corporation and with PriceSmart, Inc., and the founder and CEO of a privately owned biotech company, Psynomics, based on medical technology derived from the University of California, San Diego. Mr. May served as a faculty member and Assistant Dean of UCSD's Rady School of Management from 2005 to 2009.
During his tenure as PriceSmart's Chief Operating Officer, Mr. May led the company from startup to growth over three years that included establishing 22 stores in 11 countries, reaching annual revenues of more than $500 million, achieving profitability, and expanding staff from 356 to more than 4,200.

"In addition to its therapeutic programs, ISCO is dedicated to building its revenue-generating subsidiaries to high levels of profitability. We view Mr. May's commercial and entrepreneurial skills as an essential part of our business plan for success," said Kenneth Aldrich, Co-Founder and Co-Chairman of ISCO.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link:http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.
Forward-looking Statements
Statements pertaining to anticipated developments, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
http://cts.businesswire.com/ct/CT?id=bwnews&sty=20111006005285r1&sid=14230&distro=ftp
International Stem Cell Corporation

Kenneth C. Aldrich, Co-Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Lippert/Heilshorn & Associates
Don Markley, 310-691-7100
dmarkley@lhai.com

Source:
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Claus-Michael Lehr – Mucosal targeting of nanomedicines in inflammatory bowel diseases

§ October 6th, 2011 § Filed under Nano Medicine Comments Off on Claus-Michael Lehr – Mucosal targeting of nanomedicines in inflammatory bowel diseases

CLINAM - May 2011

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Claus-Michael Lehr - Mucosal targeting of nanomedicines in inflammatory bowel diseases

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1st International Workshop on Nanomedicines

§ October 4th, 2011 § Filed under Nano Medicine Comments Off on 1st International Workshop on Nanomedicines

Welcome address and objectives of the workshop by Patrick Le Courtois

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1st International Workshop on Nanomedicines

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KM Weltring – How to keep ethics in Nanomedicine whithin daily life and work routine ?

§ October 3rd, 2011 § Filed under Nano Medicine Comments Off on KM Weltring – How to keep ethics in Nanomedicine whithin daily life and work routine ?

CLINAM - May 2011

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KM Weltring - How to keep ethics in Nanomedicine whithin daily life and work routine ?

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Representative Brian Bilbray Meets with International Stem Cell Executives to Discuss Research Funding

§ October 2nd, 2011 § Filed under Nano Medicine Comments Off on Representative Brian Bilbray Meets with International Stem Cell Executives to Discuss Research Funding

International Stem Cell Corporation (OTCBB: ISCO) today announced that Representative Brian Bilbray recently met with Company executives, including Chairman Kenneth Aldrich, President and Chief Executive Officer Andrey Semechkin, and Senior Vice President Kurt May, to discuss key federal government issues relating to stem cell research. Rep. Bilbray represents California's 50th congressional district, which includes portions of San Diego's North County.
Following the meeting, Rep. Bilbray stated, "I have tremendous respect for the innovative healthcare companies in my district, such as International Stem Cell, that are at the forefront of developing important new treatments and therapies. I'm committed to helping remove unnecessary regulations and barriers that may inhibit the research of new life science technologies, and I greatly appreciate the efforts of ISCO's management team to clarify many of the issues surrounding their work."
Said Dr. Semechkin, "We are very pleased to have the opportunity to meet with Congressman Bilbray and explain the importance of our parthenogenesis technology and how it differs from human embryonic stem cell development, particularly from an ethical standpoint. We look forward to continued discussions with Congressman Bilbray and his colleagues regarding the Dickey-Wicker Amendment. We believe that with increased understanding of our technology the National Institutes of Health (NIH) will support parthenogenesis research and development."
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.
Forward-looking Statements
Statements pertaining to anticipated developments, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Lippert/Heilshorn & Associates
Don Markley
310-691-7100

dmarkley@lhai.com

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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Nanomedicine – Part 2

§ October 2nd, 2011 § Filed under Nano Medicine Comments Off on Nanomedicine – Part 2

Students Santosh Boddupalli, Sandeep Gandham, Swathi Jokkapur, and Chandana Chintalapani give a presentation on "Nanomedicine" during their Global Technology class. (Group 5 Presentation.) (Part 2 of 2.)

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Nanomedicine - Part 2

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Cell Therapy & Regenerative Medicine Domains Available

§ September 25th, 2011 § Filed under Nano Medicine Comments Off on Cell Therapy & Regenerative Medicine Domains Available

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Please pardon the crass commercial nature of this post.  I try to keep self-promotion to a minimum here but I'm looking to unload a number of domains I have the related to cell therapy and regenerative medicine and thought this might be the easiest way to get the word out.  Let me know if you are interested in any of the following: 


anticyte.com*
biocellutions.com***
.
cardiacregenerativemedicine.com* 
cardiacregenmed.com* 
cardiactissuerepair.com* 
.
cellexpertsolutions.com**
.
celltherapyalliance.com* 
celltherapyassays.com*** 
celltherapycellutions.com**** 
celltherapycompany.com**** 
celltherapyconsortium.com* 
celltherapydevelopment.com***
celltherapymanufacturing.com**** 
celltherapymarketing.com* 
celltherapypartner.com* 
celltherapypatents.com**** 
celltherapysolution.com*** 
celltherapystrategies.com*** 
celltherapysupport.com* 
celltheraytech.com** 
celltherapytechnologies.com*** 
celltherapyventures.com*** 
celltherapyworks.com***
.
cellutionstrategies.com*** 
.
commerciaizingcelltherapy.com** 
commercialisingcelltherapy.com* 
commercializingcelltherapies.com** 
commercialisingcelltherapies.com* 
.
cordbloodshipper.com*** 
cordbloodshipping.com*** 
.
developingcelltherapies.com* 
.
diagnostacell.com* 
diagnostacells.com* 
diagnosticstemcells.com** 
.
discoverystemcells.com** 
.
expertcellutions.com***
.
integratedcelltherapycellutions.com** 
integratedcelltherapysolutions.com**
.
ipsbiologics.com** 
ipsbiomedical.com**
ipsbioscience.com**
ipsbiosystems.com**
ipsbiotechnologies.com** 
ipslifesciences.com**
.
longtailbiomedical.com***
longtailtherapeutics.com*** 
longtailtherapies.com*** 
.
personalizedcelltherapy.com*** 
.
regenerativecellutions.com*** 
regenerativemedicinepatents.com****
.
stemostics.com** 
stemomics.com** 
stemonics.com*** 
.
stemcellcollect.com*** 
.
strategiccellutions.com** 
strategicell.com*** 
.
thecelltherapycompany.com****
.
totalcelltherapysolution.com***
totalcelltherapysolutions.com*** 


Funky ones: 
 cellenterprise.com* 
 cellsforce.com* 
 cellsinnovations.com* 
 cellsmarket.com* 
 cellspitch.com*
 cellsrep.com* 
 cellstech.com* 
 cellsventure.com*
 iregener8.com** 


I have others - some of which are variations of ones listed above (such as with "the" in front) and would be available - some of which I'm still wanting to hold.
 _____________________________ 


 * ~$1,500 
** ~$5,000 
*** ~$10,000
**** ~$20,000

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Lifeline Skin Care Video: Care For Your Skin with Lifeline Skin Care

§ September 25th, 2011 § Filed under Nano Medicine Comments Off on Lifeline Skin Care Video: Care For Your Skin with Lifeline Skin Care

Stem Cell Skin Care
Born Different.

Lifeline Skin Care® (Lifeline) is a wholly owned subsidiary of International Stem Cell Corporation (OTCBB:ISCO), a publicly traded biotechnology company which has developed a powerful and ethical new stem cell technology called “parthenogenesis”.  ISCO created Lifeline Skin Care® to further develop its discoveries that extracts from human parthenogenetic stem cells had beneficial effects on human skin cells.
International Stem Cell is focused on advancing its human parthenogenetic stem cell technology towards finding treatments for blinding diseases of the eye, liver disease, diseases of the nervous system and diabetes.
Our goal at Lifeline Skin Care® is to help individuals improve the look and feel of their skin by combining the latest discoveries in the fields of stem cell biology, nanotechnology and skin cream formulation technology to create the highest quality, scientifically tested and most effective skin care products.

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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NANO Medicine (1-3)

§ September 22nd, 2011 § Filed under Nano Medicine Comments Off on NANO Medicine (1-3)

made by Starx*Media (Andy G.)

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NANO Medicine (1-3)

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Micro and nanotechnologies are revolutionising medicine

§ September 20th, 2011 § Filed under Nano Medicine Comments Off on Micro and nanotechnologies are revolutionising medicine

More information: ec.europa.eu. Micro and nanotechnologies are revolutionising medicine 'Almost invisible' tools are being developed by European researchers to discover diseases earlier and to treat patients better

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Micro and nanotechnologies are revolutionising medicine

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Commercial-stage Cell Therapy Companies and Products

§ September 18th, 2011 § Filed under Nano Medicine Comments Off on Commercial-stage Cell Therapy Companies and Products

Below is sample list of companies with cell therapy products* on the market in Europe, USA, or Japan.

Company                                                    Product              
Advanced BioHealing (now part of Shire)       Dermagraft
Aliktra                                                       MySkin
Avita Medical                                             ReCell® Spray-On Skin
Bio-Tissue                                                 Prokera
Bio-Tissue                                                 AmioGraft
BioTissue Technologies                              BioSeed-C
BioTissue Technologies                              chondrotissue
Cytori                                                        Celution System
euroderm                                                   Epidex
euroderm                                                   EpiGraft
Fidia Farmaceuitici                                     Hyalograft 3D
Fidia Farmaceuitici                                     Laserskin
Fidia Farmaceuitici                                     Hyalograft C
J-TEC Epidermis                                       Japan Tissue Engineering Co.
J-TEC Cartilage                                         Japan Tissue Engineering Co.
J-TEC Corneal Epithelium                          Japan Tissue Engineering Co.
Nuvasive                                                    Osteocel Plus
Provenge                                                    Dendreon
Sanofi (previously Genzyme)                       Epicel
Sanofi (previously Genzyme)                       Carticel
TiGenix                                                      ChrondroCelect
Therakos                                                    Therakos Photopheresis

* This list does not purport to be exhaustive of all cell therapy products legally sold in these regions.  This list  does not include approved products in other highly-regulated jurisdictions, such as Australia, New Zealand, or Korea, for example.  This list also excludes those cell-based treatments provided as a hospital or clinic-based service such as stem cell transplantation (hospital) or Regenexx (Regeneration Sciences, Inc.).

For the purposes of this list, “cell therapy” is defined loosely as any product which has in it live cells when administered to the patient including tissue transplants and devices.

Note that some of these products may be subject to emerging regulatory restrictions under the EMA ATMP regulations which may result in them having to be pulled from the market by the end 2012 at the latest.

If you would like to suggest any revisions or additions to this list, please do so in the comment section below.

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§ September 18th, 2011 § Filed under Nano Medicine Comments Off on

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Cell Therapy Group and BioBusiness.TV are pleased to announce they are collaborating to build a "cell therapy" video channel focused on the cell therapy industry.  The initiative is part of BioBusiness.TVs "Best of the Web" initiative intended to bring together publicly available video content that complements their original content.

The Cell Therapy channel will focus on cell-based therapeutic products which are in clinical development by or are commercially available from companies around the world.   We will update this channel frequently.

To view other video content, see Cell Therapy Group’s YouTube channel.

To recommend video content, submit your comments below.

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

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Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy

§ September 18th, 2011 § Filed under Nano Medicine Comments Off on Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy

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The FDA recently issued an untitled letter to Parcell Laboratories and its contract manufacturing organization, New England Cryogenic Center (NECC), pertaining to the product PureGen™ Osteoprogenitor Cell Allograft intended for the "repair, replacement, reconstruction of musculoskeletal defects". The letter stated:

"The PureGen™ Osteoprogenitor Cell Allograft is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. Based on this information, we have determined that your actions have violated the Act and the PHS Act."

This would appear to be an indicator that the FDA does not intend to relax enforcement of its view of how autologous cell therapies are to be regulated despite its ongoing litigation on this very subject with RSI.

As followers of this blog know, since the battle's inception in 2008 I have followed the case of Regenerative Sciences, Inc and their war with the FDA over their right to provide certain autologous cell therapy treatments to patients in certain circumstances without FDA approval. My first blog entry on the topic was in September 2008 in which I pointed out that the FDA had written a letter to RSI that July taking issue with some of their practices.

My next blog on the subject was February 2009 in which I concluded "I think the FDA is building its case and a showdown is on its way to Denver-town."

At the advice of legal counsel, I pointed out in a March 2010 blog entry that my reference to FDA's July 2008 letter to RSI was not officially a "warning letter" as that is defined and as I had referred to it but rather an "untitled letter". I also commented that FDA's lack of enforcement action against RSI to-date was emboldening medical practitioners into thinking FDA was reconsidering their position on the legality of providing autologous, expanded cells to patients outside of an FDA-cleared IND or BLA.

I took some satisfaction in announcing on my blog in August 2010 that the FDA had finally taken action against RSI. My satisfaction was not rooted in a belief that the FDA is right (I've always been agnostic as to which side is right) but in the sense that things had occurred as I had predicted they would.

The action the FDA chose to take against RSI was to seek an injunction against RSI from continuing to provide the "offending" treatment - a version of the Regenexx™ procedure using mesenchymal stem cells (“MSCs”) grown outside the body after harvest for the later infusion back into the donor-patient for the treatment of various orthopedic conditions - which the FDA alleges is a "product" falling under its regulatory authority but for which RSI has never received any FDA clearance to provide to patients.

RSI counterclaimed against the United States, challenging the FDA’s authority to regulate the Regenexx™ Procedure in question and challenging certain FDA regulations. The United States moved to dismiss Defendants’counterclaims and for summary judgment.

I have continued to follow the case relatively closely through a number of source (see this sample media coverage in OthosSpineNews) as it continued to progress. Last month, for example, a blog I follow posted an eloquent case in support of RSI's position with the help of Mary Ann Chirba, J.D., D.Sc., M.P.H. of Boston College Law School.

So it was with much interest that I was recently notified of an order issued by the court which appears to have the potential to take the case in a very unexpected direction with enormous potential ramifications.

The context is that the judge was reviewing the FDA's motion for summary judgment, RSI's response, and FDA's reply when the judge issued this order to show cause.

At its essence the Judge has ordered the FDA to file a brief no later than 26 September showing the court why the term “chemical action” applies to stem cells. It is is a short Order the core of which reads as follows:

The Government finds its definition for a “drug” in the FDCA: “The term ‘drug’means . . . articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” 21 U.S.C. § 321(g)(1)(B)&(C).

This definition, at least as to subsection (C), would be broad enough to encompass a boot on a patient’s ankle to hold it secure after ankle surgery. The Court doubts that was Congress’s intent.

Neither party references the definition for “device,” found in the statute at 21 U.S.C. § 321(h). A “device,” is a certain kind of “article” used in diagnosis, cure, mitigation, treatment or prevention of disease, 21 U.S.C. § 321(h)(2), but which, presumably unlike a drug, “does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.” 21 U.S.C. § 321(h).

These contrasting definitions immediately raise the question of why the Court should not interpret the meaning of the word “drug” to include not only an article for use in diagnosis, etc., and intended to affect the structure or function of a patient, but also an article that “achieve[s] its primary intended purposes through chemical action” and which is “dependent upon being metabolized for the achievement of its primary intended purposes.” Id.

The United States is ORDERED TO SHOW CAUSE why the Court should not read the definition of “device” at 21 U.S.C. § 321(h) as informing and restricting the definition of “drug” at 21 U.S.C. § 321(g)(1)(B)&(C).

It will be most curious to see how the FDA argues out of the corner that many believe the Judge has painted the agency. The FDA recently defined “chemical action” in its draft "Guidance for Industry and FDA Staff: Interpretation of the Term “Chemical Action” in the Definition of Device under Section 201(h)of the Federal Food, Drug, and Cosmetic Act". What is curiously absent from the document is any mention of cells or HCT/P’s despite CBER’s approval stamp on the document.

Another line of argument centers around whether cells - notably 'stem' cells - are “metabolized" as that term is defind.

If one extrapolates the ramifications of where the court appears to be currently leaning, the implications of this judgment may have far-reaching implications for biologics in general well beyond cell therapy and certainly well beyond autologous cell therapy.

As some quite logically argue, one potential scenario is that this judge rules all biologics fail to fall within the legislative "drug" definition. The argument goes like this. The drug regulations live under title 21, which has narrow definitions for what constitutes a drug. The FDA’s authority over biologics comes from title 42, which is merely to control communicable disease transmission in transplants, with no authority to take the drug provisions from title 21 and apply them to title 42. So the agency is risking a loss of control over all biologics.

What’s curious here - and perhaps somewhat ironic for RSI at this stage - is that they only ever set out to challenge their ability to regulate autologous cells used by a physician as part of his or her medical practice yet now the FDA's authority to govern all biologics is currently under question.

The fact that I cannot fathom the courts striking FDA's jurisdiction over all biologics when the dust settles on this case does not make the arguments any less compelling and it does leave open the possibility that a lower court Judge such as the one presiding over this case may be inclined to make a ruling which essentially ensures the issues are punted to the appellate courts for a more considered ruling. In such circumstances, even if the FDA were to prevail at the end of the day (perhaps a decade down road) the uncertainty such a ruling would rain down on the sector would be commercially stifling - even if if were just limited to autologous cell therapy let alone if were any broader.

My dated and unpolished law degree can only take this analysis so far and anyone interested in some further but delightfully light and practical reading on the potential ramifications of the case could do no better than read a paper published recently by the relevant practice groups at the law firm K&L Gates entitled "Cultured Stem Cells for Autologous Use:Practice of Medicine or FDA Regulated Drug and Biological Product in which they review the case and its potential implications - the latter of which the authors are not guilty of underestimating in the following concluding sentence of their analysis:

The court’s decision will, to a large degree, dictate the types of legal strategies and business models that will be necessary to successfully perform stem cell procedures in the future.

_____________

post-script: The potential stink of commercial uncertainty wafting from this case is even more egregious when combined with the uncertainty around what to expect from the FDA in its much-anticipated and typically overdue guidance on adipose-derived cell therapies.

Rumor has it that the FDA is leaning toward considering most (if not all) means of deriving cell populations from adipose tissue (typically lipoaspirate) to be governed as what we colloquially refer to as a '351' thus taking it out of the purview of the practicing physician and into the hands of companies prepared to follow the traditional "drug development' model for new medicines. The rationale here is that the mechanical and/or enzymatic digestion required to separate the desired cell populations from the stroma take the process beyond "minimal manipulation'.

Watch for this guidance from CBER OCTGT in the weeks to come and/or any relevant rulings by the Tissue Reference Group. This would be a serious blow to those building business models around point-of-care, autologous adipose-derived cell therapy treatments.

What makes this even more interesting is the pace of which US-based medical practitioners (and/or companies supporting them) are adopting and selling autologous cell-based products, services and/or treatments for sundry indications in ways which many would argue are apparently in obvious and flagrant disregard for the FDA's regulatory authority over such treatments. Included for consideration on such a list would be the following:

IntelliCell Biosceinces

eternaMD

Arizona Stem Cell Center

.

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

Source:
http://feeds.feedburner.com/CellTherapyBlog

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Cancer Stem Cell Chronicle

§ September 18th, 2011 § Filed under Nano Medicine Comments Off on Cancer Stem Cell Chronicle

About 3 months ago, as an experiment, I launched the Cancer Stem Cell Chronicle, an online daily newspaper that's based on excerpts from 3 streams of content: 1) Twitter content tagged #cancerSC, 2) Twitter content that includes the keywords "cancer stem", and, 3) content derived from a PubMed RSS feed for the search term "cancer stem".

The experiment looks promising. The CSC Chronicle is beginning to provide a convenient way to monitor recent research news about cancer stem cells. Archives are available. The section headings in the CSC Chronicle aren't very meaningful, and should be ignored.

The CSC Chronicle is hosted by Paper.li.

Source:
http://cancerstemcellnews.blogspot.com/feeds/posts/default?alt=rss

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International Stem Cell to Present at the Rodman & Renshaw Annual Global Investment Conference on September 12

§ September 11th, 2011 § Filed under Nano Medicine Comments Off on International Stem Cell to Present at the Rodman & Renshaw Annual Global Investment Conference on September 12

International Stem Cell Corporation (OTCBB: ISCO) announced today that Kenneth Aldrich, Chairman, is scheduled to present at the Rodman & Renshaw Annual Global Investment Conference on Monday, September 12, 2011 at 11:40 a.m. Eastern (8:40 a.m. Pacific). The conference takes place at the Waldorf Astoria Hotel in New York City.
A webcast of the International Stem Cell Corporation presentation can be viewed live at http://www.wsw.com/webcast/rrshq20/isco. The presentation will be archived and available at the same link for 90 days. After the conference, a link to the presentation will also be posted to the ISCO website, http://www.intlstemcell.com.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.
International Stem Cell Corporation
Kenneth C Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Lippert/Heilshorn & Associates
Don Markley
310-691-7100
dmarkley@lhai.com

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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Video: The Promising Cells Presented by International Stem Cell Corporation

§ September 11th, 2011 § Filed under Nano Medicine Comments Off on Video: The Promising Cells Presented by International Stem Cell Corporation

Ken Aldrich of International Stem Cell Corporation (ISCO.OB) on the latest research involving stem cell technology utilizing unfertilized eggs, as a basis for cell generation with a goal toward organ transplants which are immune to rejection by the body...as well as other applications. Mr. Aldrich also discusses neurological applications focusing on reversing Parkinson's disease.
This corporate video was produced by Big Sky Productions Inc. (BGSI.OB).
Executive Producer: Ellis Martin
Producer and Creative Director, Narrator, Editor: Bob Lange
http://www.ellismartinreport.com  http://www.intlstemcell.com  
contact: bigskymedia@yahoo.com

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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Living Polymerization and nano-medicine

§ September 7th, 2011 § Filed under Nano Medicine Comments Off on Living Polymerization and nano-medicine

More:
Living Polymerization and nano-medicine

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Nanomedicine — a Key Ingredient of the Medicine of the Future

§ September 6th, 2011 § Filed under Nano Medicine Comments Off on Nanomedicine — a Key Ingredient of the Medicine of the Future

(11. Juli 2011) Recognizing that the root of disease is often at the nanoscale, the question arises if medical diagnosis and therapy would not also work best at the nanoscale

Read this article:
Nanomedicine -- a Key Ingredient of the Medicine of the Future

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