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Adult Stem Cells Used To Rebuild Heart Tissue Video. More at http://www.stemcellfusion.com

After they harvested approx. 14 Million Stem Cells from the blood thru the catheter, they had to remove it....not a fun process

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Stem Cell #8 Vas Cath Removal 04/28/11

http://www.globalchange.com New ways to repair damaged heart following heart attack, myocardial infarction, damaged heart muscle, tissue necrosis, cell death. New ways to reduce mortality and improve cardiac output following heart attacks. Recovery after a coronary, by speeding up heart repair

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Heart repair using own stem cells after heart attack: Future Health keynote speaker

Students Connie Dillard, Nancy Johnson, Cathy Luhrsen

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Adult Stem Cell

In July 2011, Siteman Cancer Center's bone marrow and stem cell transplant program completed its 5000th transplant. Transplant patients from throughout the program's 31-year history discuss their experiences.

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Bone Marrow and Stem Cell Transplant Patients Share Their Stories

http://www.CellularReprogramming.com The CellularReprogramming.com domain name is for sale! This domain is a perfect fit for any stem cell or bio-tech company specializing in iPS Cells and stem cell reprogramming. Visit us today for more information! http

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Cellular Reprogramming Stem Cell Domain Name For Sale! - CellularReprogramming.com

http://www.juntadeandalucia.es Since its creation in November 2003, the Andalusian Stem Cell Bank has been increasing its research activity and growing at the same rate as the advances in stem cell research in national and international arenas. The Andalusian Stem Cell Bank was the first structure established in Spain specifically designed for the storage, distribution and characterization of embryonic stem cells. Having available cell lines produced under GMP standards was one of the most persistent requests of the scientific community in the field of cell therapy.

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Andalusian Stem Cell Bank

(HealthDay News) -- People who become very afraid of dying in the moments during and days after a heart attack also seem to have more inflammation, an indicator that they may, in the long run, do worse than patients who are less fearful, a small British study suggests.

The finding, published online June 1 in the European Heart Journal, "reminds us of the connection between the mind and the body," said Dr. Suzanne Steinbaum, a preventive cardiologist with Lenox Hill Hospital in New York City.

"This trial shows us that when patients are so fearful, there's an increase in inflammation and decrease in heartbeat variability, which could lead to poor outcomes. So we must address not only the body issues but the mind issues as well," she said.

Added Dr. Robert Gramling, associate professor of family medicine at the University of Rochester Medical Center in New York: "This and the vast literature related to emotions and mind/body interactions are confirmatory that understanding people's emotional response does interplay with the biologic mechanisms. Read more...

Cardiofy Heart Care Supplement

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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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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

.

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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

For more information on gene therapy visit http://www.healthcentral.com. Scientist are using human stem cells to make advances in reversing paralysis, cerbral palsy, congenital heart disease, and many more debilatating conditions.

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Stem Cells May Reverse Paralysis, Brain Damage, and Organ Failure

Juan Carlos after having Stem Cell treatment.

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Walking after Spinal Cord injury and Stem Cells

Scripps Research Institute scientist Kristopher Nazor discusses Fragile X Syndrome, then circles back to how stem cell therapy might be able to help Fragile X and Alzheimer's patients. Talk given on Aug. 4 as part of presentation by researchers in Jeanne Loring's lab to patients with Parkinson's disease.

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Kristopher Nazor 2

Jeanne Loring talks about stem cells, part 1. Part of meeting between Parkinson's patients and researchers in Loring's lab about the potential of induced pluripotent stem cell therapy, Aug. 4, 2011

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Jeanne Loring talks about stem cells, part 1

(Part 2 of 4) Cardiovascular Therapies: Spotlight on Stem Cell Research "Cardiac Tissue Regeneration and Biosurgery" On March 10, 2011, W. Douglas Boyd, MD, spoke about his work towards developing stem cell-based technologies to repair heart tissue damaged by cardiovascular disease. Boyd is a professor of surgery and director of robotics and biosurgery for the UC Davis Health System

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Cardiovascular Therapies: Spotlight on Stem Cell Research - Douglas Boyd

(Part 4 of 6) Albert Lane, MD, spoke at the "Spotlight on Disease Team Awards: Genetic Skin Disease," an educational event presented at the CIRM Governing Board meeting on February 4, 2010. Lane is chair of the department of dermatology and professor of dermatology and pediatrics at Stanford School of Medicine.

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iPS Stem Cell-Based Treatment of Epidermolysis Bullosa

The donation and infusion process for a stem cell bone marrow transplant. http://www.caringbridge.org/visit/jasonwilliams

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Bone Marrow/Stem Cell Transplant

Dr. George Daley of Boston Children's Hospital explains the concept of Induced Pluripotent Stem Cells.

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IPs cells Part 1

Read more from the original source:
The Skin Gun (Stem Cell research to replace burnt off skin. Done in 3 days!)