Host Dr. David Bertone, PT, DPT, OCS inteviews Dr Edward Magaziner, MD on the latest procedures used in the field of Orthopedic Regenerative Medicine including prolotherapy, platelet-rich plasma and stem cell transplants for chronic pain, tendonitis and arthritis
Read the original here:
You and Your Heath TV Show - Orthopedic Regenerative Medicine Part 1 - Video
TEDxPhoenix 2009 presents Dr. Jane Maienschein, Professor of Biology, School of Life Sciences, Arizona State University
More here:
TEDxPhoenix - Jane Maienschein - Stem Cells, Regenerative Medicine and Us - Video
Ann Anderson Kiessling, Ph.D. (Harvard Medical School and the Bedford Stem Cell Research Foundation, Bedford Massachusetts) was introduced by Dorrie Fontaine, Ph.D., RN, FAAN (Sadie Health Cabaniss Professor and Dean, School of Nursing, University of Virginia) who also described a newly established award by the School of Nursing, called the "Alumni Achievement Award," which is awarded to a nursing graduate who has contributed beyond the field of nursing.
Read the rest here:
Retroviruses, Reproduction, and Regenerative Medicine: The Influence of Federal Funding - Video
The McEwen Centre for Regenerative Medicine was established at University Health Network in 2003 with a generous donation from Rob and Cheryl McEwen, which they matched in 2006 with a second donation. The McEwen Centres vision is to be a world-renowned centre for stem cell biology and regenerative medicine. To achieve this ambitious goal, the team of McEwen Investigators is working together to accelerate the development of more effective treatments for conditions such as heart disease, diabetes, respiratory disease and spinal cord injury
"Our discovery of the 'pure' human blood stem cell could open up a new era in regenerative medicine," says principal investigator John Dick, who holds a Canada Research Chair in Stem Cell Biology and is a Senior Scientist at the McEwen Centre for Regenerative Medicine and the Ontario Cancer Institute, University Health Network. Release available here: http://www.uhn.ca
Read the original:
A New Era in Regenerative Medicine - Video
Learn how newborn stem cells are being researched as treatment for patients with hearing loss. An innovative study held at Children's Memorial Hermann Hospital in Houston will be evaluating the effects of a child's own cord blood as treatment for acquired hearing loss. Only CBR offers your family exclusive access to several groundbreaking clinical trials such as this one.
Excerpt from:
Hearing Loss Research: CBR Exclusive! Stem Cells Explored as Cure for Hearing Loss - Video
Huge gains in tissue regeneration are happening now. Adult stem cells are used in these groundbreaking procedures and are the foundation for many more in trials today
Visit link:
An amazing story of stem cells, regenerative medicine and healing power: - Video
metromd.net What is Regenerative Medicine? An overview of Regenerative Medicine, Stem Cells and HGH hormone replacement by Alex Martin, MD
Read more here:
What is Regenerative Medicine? | Los Angeles | Hollywood | Beverly Hills - Video
(June 1, 2010) Renee Reijo Pera, Ph.D., and Professor Michael Longaker discuss the future of regenerative medicine and the promise that stem cell research holds for this field. During the final quarter of the Stanford Mini Med School, some of the most timely and important topics in contemporary medicine and the biosciences are addressed
Read this article:
Regenerative Medicine and Applications of Stem Cell Research - Video
Host Dr. David Bertone, PT, DPT, OCS inteviews Dr Edward Magaziner, MD on the latest procedures used in the field of Orthopedic Regenerative Medicine including prolotherapy, platelet-rich plasma and stem cell transplants for chronic pain, tendonitis and arthritis. This showed is part of the You and Your Health series aired on Old Bridge TV.
Read more from the original source:
"You and Your Health" TV Show - Orthopedic Regenerative Medicine - Video
Robert Ames, PhD, GlaxoSmithKline, USA; From the SBS Symposium Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine. Held in Boston, MA, USA - September 2-3, 2009.
Excerpt from:
Closing Remarks, Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine - Video
Learn more about Mayo Clinic's new Regenerative Medicine Consult service from a Mayo Clinic expert on stem cell therapies.
View post:
Dr Alimorad Farshchian said: Regenerative Medicine shows the Potential of Stem Cell Therapies for ALS and SMA.
Excerpt from:
Dr Farshchian: Regenerative Medicine shows Potentials - Video
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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
Tweet
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
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.
Tweet
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:
.
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.
Tweet
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:
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