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Stem cell politics behind forgery chargesPMA president

By NEVAGiles23

Leo Olarte, M.D., PMA president. PHOTO from http://www.philippinemedicalassociation.org

MANILA, Philippines Politics over stem cell treatment may be behind the move to slap an ethics case against him for allegedly falsifying signatures, the Philippine Medical Association (PMA) president said.

In an interview over Inquirer Radio 990 AM on Monday, Dr. Leo Olarte said he found it suspicious that Professional Regulation Commission (PRC) Chair Teresita Manzala announced the ethics case against him on the day of the elections for the next PMA president.

He claimed Manzala slapped the ethics case before the PRC to ruin his chances of being re-elected in the countrys largest doctors association.

Olarte said Manzala has connections to doctors who are against stem cell medicine. Olarte is a supporter of stem cell treatment.

Manzala released the statement on the day of our elections specifically to destroy my name Manzala (also) has connections to doctors who are against stem cell. I am pro-stem cell treatment while my rival (for president) is not, Olarte said in Filipino.

In a Philippine Daily Inquirer report on Sunday, Olarte and his four predecessors were charged with fraud in the registration of the Philippine Society for Stem Cell Medicine (PSSCM) in the Securities and Exchange Commission.

Olarte and the four others Bu Castro, Rey Melchor Santos, Oscar Tinio and Jose Sabili were accused of forging Manzalas signature in an endorsement for the incorporation of the PSSCM.

But Olarte blamed a syndicate behind the alleged forgery.

He said the PMA paid a private trading company to process the PSSCMs incorporation with the SEC. The doctor did not name the company.

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5 doctors charged with falsifying papers to get certificate for stem cell group

By NEVAGiles23

PRC: Stem cell group submitted fake SEC registration. At a press conference in Manila on Monday, March 17, Professional Regulation Commission chairperson Teresita Manzala said the PRC endorsement documents allegedly submitted by the Philippine Society for Stem Cell Medicine (PSSCM) to the Securities and Exchange Commission (SEC) were fabricated and have her tampered signature. The SEC previously revoked the corporate registration of the PSSCM. Danny Pata

In a statement, Professional Regulation Commission (PRC) chair Teresita Manzala said she has asked the Professional Regulatory Board of Medicine (PRBOM) to initiate, investigate and file charges against doctors Leo Olarte, Bu Castro, Rey Melchor Santos, Oscar Tinio and Jose Asa Sabili before the PRCs legal division.

Olarte is the current president of the PMA.

The five doctors are all incorporators of the Philippine Society for Stem Cell Medicine (PSSCM,) which was able to obtain an SEC certificate despite previously being denied corporate registration. They were able to do this, said the statement, by submitting false PRC endorsements to the commission.

The PRBOM eventually got hold of a copy of the SEC Registration. On examination of the supposed PRC Endorsement, it was noted that the reference regulatory law used was the Philippine Veterinary Law of 2004, instead of Republic Act 2382, otherwise known as the Medical Act of 1959, and there appeared a signature of the PRC Chairperson, the PRC statement said.

Manzala said complaints were filed against the doctors for unprofessional, dishonorable and unethical conduct.

According to the statement, the incorporators later denied participation in obtaining the SEC registration, instead naming a Dr. Mike Aragon as the person who obtained the certification.

In a notarized affidavit submitted to the PRBOM, 'Dr. Mike Aragon' declared that he was the person authorized to register a corporation to be called 'Philippine Society for Stem Cell Medicine' and admitted paying 15,000 pesos to a trading company for them to file the necessary documents for incorporation of the PSSCM, the PRC statement said.

But Aragon claimed to have had no participation whatsoever in the actual processing of the SEC papers for incorporating the PSSCM. Patricia Denise Chiu/BM, GMA News

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DINUKTOR | 5 stem cell society doctors face raps for submitting falsified PRC endorsement to SEC

By NEVAGiles23

By: Jet Villa, InterAksyon.com March 17, 2014 7:45 AM

FILE PHOTO

InterAksyon.com The online news portal of TV5

MANILA - Five doctor-incorporators of the Philippine Society for Stem Cell Medicine (PSSCM) face charges and may have their medical licenses revoked for submitting a fabricated endorsement from the Professional Regulation Commission (PRC) to the Securities and Exchange Commission (SEC).

Among them are chairman of the Philippine Medical Association Leo Olarte, PSSCM treasurer and legal counsel; Bu Castro, secretary; Rey Melchor Santos, president; Oscar Tinio, vice president; and Jose Asa Sabili, chairman.

In a statement, PRC Chairperson Teresita Manzala on Sunday said she directed the Professional Regulatory Board of Medicine (PRBOM) to initiate, investigate, and file charges against the five doctors before the PRCs legal division for unprofessional, dishonorable, and unethical conduct.

Earlier on 10 January 2014, the SEC cancelled the registration of the PSSCM for submitting a fabricated document. In an order signed by SEC Acting Director Ferdinand Sales, the commission said the PSSCM had committed fraud in procuring its Certificate of Incorporation for its application for corporate registration.

Wherefore, premises considered, the Certificate of Registration of Philippine Society for Stem Cell Medicine with SEC Registration No. CN201303986, approved on March 6, 2013 is hereby revoked, the order reads.

Falsified endorsement

SEC said PSSCM submitted a 2ndPRC Indorsement, dated 20 February 2013, supposedly from Manzala. But on14 August 2014, SEC received a letter-complaint from Manzala informing the commission that the signature appearing in the alleged favorable indorsement from PRC was not hers and, thus, falsified.

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DINUKTOR | 5 stem cell society doctors face raps for submitting falsified document to SEC

By LizaAVILA

By: Jet Villa, InterAksyon.com March 17, 2014 7:45 AM

FILE PHOTO

InterAksyon.com The online news portal of TV5

MANILA - Five doctor-incorporators of the Philippine Society for Stem Cell Medicine (PSSCM) face charges and may have their medical licenses revoked for submitting a fabricated endorsement from the Professional Regulation Commission (PRC) to the Securities and Exchange Commission (SEC).

Among them are chairman of the Philippine Medical Association Leo Olarte, PSSCM treasurer and legal counsel; Bu Castro, secretary; Rey Melchor Santos, president; Oscar Tinio, vice president; and Jose Asa Sabili, chairman.

In a statement, PRC Chairperson Teresita Manzala on Sunday said she directed the Professional Regulatory Board of Medicine (PRBOM) to initiate, investigate, and file charges against the five doctors before the PRCs legal division for unprofessional, dishonorable, and unethical conduct.

Earlier on 10 January 2014, the SEC cancelled the registration of the PSSCM for submitting a fabricated document. In an order signed by SEC Acting Director Ferdinand Sales, the commission said the PSSCM had committed fraud in procuring its Certificate of Incorporation for its application for corporate registration.

Wherefore, premises considered, the Certificate of Registration of Philippine Society for Stem Cell Medicine with SEC Registration No. CN201303986, approved on March 6, 2013 is hereby revoked, the order reads.

Falsified endorsement

SEC said PSSCM submitted a 2ndPRC Indorsement, dated 20 February 2013, supposedly from Manzala. But on14 August 2014, SEC received a letter-complaint from Manzala informing the commission that the signature appearing in the alleged favorable indorsement from PRC was not hers and, thus, falsified.

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Registration of PH stem cell group revoked

By Dr. Matthew Watson

MANILA - The Securities and Exchange Commission (SEC) revoked the corporate registration of the Philippine Society for Stem Cell Medicine (PSSCM) for submitting fabricated endorsement from the Professional Regulation Commission (PRC).

In a five-page order, SEC acting director Ferdinand Sales said the PSSCM committed fraud in procuring its Certificate of Incorporation.

He said that as required under Section 17 of the Corporation Code, the PSSCM submitted a favorable endorsement from the PRC to support its application for corporate registration.

But he said the SEC found that the 2nd PRC Indorsement dated Feb. 20, 2013 submitted by PSSCM was falsified.

Considering the submission of a falsified PRC endorsement, there is fraud in procurement of respondents certificate of registration. The falsified document was relied upon by this Commission in approving the registration application of the respondent, Sales noted.

He added that had the SEC known about such defect early on, it would have not accepted and approved the registration application of the respondent.

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PMA head, 4 other doctors probed by PRC over alleged fraud, forgery

By daniellenierenberg

MANILA, Philippines The president of the Philippine Medical Association (PMA) and his four predecessors have been slapped with ethics cases before the Professional Regulation Commission (PRC) for alleged fraud in the registration of the Philippine Society for Stem Cell Medicine (PSSCM) in the Securities and Exchange Commission.

In a statement on Sunday, PRC Chair Teresita Manzala said she has directed the Professional Regulatory Board of Medicine (PRBOM) to file cases against doctors Leo Olarte, Bu Castro, Rey Melchor Santos, Oscar Tinio and Jose Sabili for forging her signature in the incorporation of the PSSCM.

The Commission directed the PRBOM to initiate the filing of a case of unprofessional, dishonorable and unethical conduct against the five incorporators, said Manzala, adding that a case was already pending before the PRC legal division.

Olarte, Castro, Santos, Tinio and Sabili were identified as the incorporators of the PSSCM, whose registration has been revoked by the SEC.

Investigation showed the doctors submitted an application to the SEC for the corporations registration in February 2013. As part of the procedure, PRBOM sent a communication to the five incorporators requiring them to submit pertinent documents but did not receive any response from the doctors. Without the documents, the PRBOM instead placed the application papers on hold. It never submitted the application papers and the required PRC endorsement to the SEC for final approval, said Manzala.

But several months later, the board received information that the PSSCM was able to register with the SEC, based on an endorsement signed by the PRC chair.

On examination of the supposed PRC endorsement, it was noted that the reference regulatory law used was the Philippine Veterinary Law of 2004, instead ofthe Medical Act of 1959, and there appeared a signature of the PRC chair, she said.

Manzala said three of the incorporators, whom she did not identify, denied participation in obtaining the SEC registration and pointed to Dr. Mike Aragon, the PMA spokesperson, as the one responsible for registering the organization at SEC.

In a notarized affidavit submitted to the PRBOM, Aragon admitted he was appointed to register the corporation at SEC but added that he paid P15,000 to a trading company to file the necessary documents needed for the incorporation of PSSCM. He denied involvement in the actual processing of the SEC papers after making the payment.

Manzala submitted a complaint to the SEC, charging her signature was forged in August 2013.

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Stem Cell Therapy for NFL Knee / ACL Injuries & Sports Medicine – Dr Rodney Dade – Video

By NEVAGiles23


Stem Cell Therapy for NFL Knee / ACL Injuries Sports Medicine - Dr Rodney Dade
WASHINGTONIAN Mag Top Doctor and Regenerative Medicine and Pain Management physician Dr Rodney Dade at StemCell ARTS discusses the tragic uptick in NFL knee ...

By: StemCell ARTS

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Stem Cell Therapy PRP and Its Success in Treating Older Patients – Video

By Dr. Matthew Watson


Stem Cell Therapy PRP and Its Success in Treating Older Patients
Dr Rodney Dade discusses how regenerative medicine therapies work very well in older patient populations--ages 65 and above in particular--especially the Reg...

By: StemCell ARTS

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Donor Drive Held for Pasadena Girl, 2, in Need of Bone Marrow Transplant

By raymumme

The parents of a 2-year-old Pasadena girl who was diagnosed with an aggressive form of leukemia have renewed their call for help in the search for a bone marrow donor, after stem cells taken from the girls father did not match.

Sofia Flores, shown in a family photo, needs a bone marrow donor.

The latest in a series of donor drives was held Saturday at Orchard Supply Hardware, located at 3425 E. Colorado Blvd. in Pasadena.

Sofia Flores story first came to light in October 2013 when her parents asked for help in finding a bone marrow donor for their daughter.

Sofia needed a marrow transplant to combat acute myeloid leukemia, according to A3M, a Los Angeles nonprofit that is helping Sofias parents seek a match for the little girl.

However, after an extensive search, no match was found.

On Jan. 23, her father donated his stem cells to her, which was the only alternative available at the time, according to Erica Westfall, Sofias mother.

But the treatment was not successful and Sofias cancer relapsed.

Sofias last chance for survival would be a transplant from an unrelated donor in the next two months, according to her mother.

Weve been searching for a bone marrow match even harder because this is her last chance, her father Ignacio Flores said in a video released to news media on Monday.

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Turning Stem Cell Biology into Stem Cell Medicine – Video

By Dr. Matthew Watson


Turning Stem Cell Biology into Stem Cell Medicine
Mark Noble, Professor of Genetics, Neurology, Neurobiology and Anatomy; Director of the University of Rochester Stem Cell and Regenerative Medicine Institute...

By: UniversityRochester

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VIbes-Advanced Stem Cell Therapy & PRP Treatment 12 Feb’14 – TV5 Hyderabad – Video

By raymumme


VIbes-Advanced Stem Cell Therapy PRP Treatment 12 Feb #39;14 - TV5 Hyderabad

By: Vibes Healthcare Ltd

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New cell line should accelerate embryonic stem cell research

By Sykes24Tracey

University of Washington researchers have created a line of human embryonic stem cells with the ability to develop into a far broader range of tissues than most existing cell lines.

"These cells will allow us to gain a much greater understanding of normal embryonic development and have the real potential for use in developing ways to grow new tissues and organs for transplantation," said Carol Ware, a professor of comparative medicine. She is the lead author of a paper describing the new cell line.

The findings are reported in the March 10 issue of the journal Proceedings of the National Academy of Sciences. The cells, called nave embryonic stem cells, normally appear at the earliest stages of embryonic development. They retain the ability to turn into any of all the different types of cells of the human body -- a capacity called "pluripotency."

Researchers had been able to develop nave cells using mouse embryonic stem cells, but to create naive human embryonic stem cells has required inserting a set of genes that force the cells to behave like naive cells.

While these transgenic cells are valuable research tools, the presence of artificially introduced genes meant the cells will not develop as normal embryonic cells would nor could they be safely used to create tissues and organs for transplantation.

In an article, Ware and her colleagues from the UW Institute for Stem Cell and Regenerative Medicine describe how they successfully created a line of nave human embryonic stem cells without introducing an artificial set of genes.

They first took embryonic stem cells that are slightly more developed, called primed stem cells, and grew them in a medium that contained factors that switched them back -- or "reverse toggled" them -- to the nave state. They then used the reverse toggled cells to develop a culture medium that would keep them in the nave state and create a stable cell line for study and research.

While the "reverse toggled" cells are much easier to create and will prove valuable research tools, Ware said, the cells that were directly derived from embryos are the more important advance because they are more likely to behave, grow and develop as embryonic cells do in nature.

The new cell line is called Elf1: "El" for the Ellison Foundation, a major supporter of the lab's work; "f" for female, the sex of the stem cell; and "1" for first.

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Stem Cell Research in pursuit of Spinal Cord Injury …

By Sykes24Tracey

(Page 1 of 2)

Because neurons (nerve cells) in the central nervous system (the brain and spinal cord) do not repair or replace themselves after being injured, researchers are investigating whether transplanting cells into an injured area can restore function.

One of the many challenges for researchers is obtaining cells that will function as neurons in the brain or spinal cord. Because a persons body doesnt have spare neurons for transplantation, efforts are being made to find other cells that can be transformed into neurons. One potential source is stem cells from human embryos. Less than a week after conception cells in an embryo begin to differentiate that is, they begin to form specific types of cells, such as bone cells, red blood cells, heart muscle cells, and so on. Stem cells are simply cells that can differentiate into other types of cells. Early in the life of an embryo stem cells have the potential to differentiate into the more than two hundred types of cells in a human body. There are other kinds of stem cells, including stem cells in adults, which can differentiate into a more limited number of types of cells.

Using embryonic stem cells for transplantation is controversial because it is necessary to first create human embryos to produce the stem cells and then kill the embryos in the process of harvesting the stem cells. Opponents of the process contend that it is unethical or immoral to create and then kill any form of human life for the purpose of harvesting stem cells. Proponents of stem cell transplantation either claim that embryos created in a laboratory have no value or significance apart from producing stem cells or that the end of helping injured or ill people justifies the means of creating and then killing human life.

Apart from the controversy about creating and killing human embryos, stem cell researchers are faced with another challenge which is partly practical and partly ethical. The bodys immune system recognizes what is part of the body and what is not. Every cell in the body has protein molecules on the surface of the cell wall that identify the cell as being part of the body (these are known as human leukocyte antigens (HLA)). These markers are recognized by the cells in our immune systems. If the immune system doesnt detect the bodys specific markers, it will sound the alarm and go on the attack. This allows our immune system to recognize and fight invaders in the form of bacteria, viruses, and fungi, protecting us from diseases that would otherwise kill us.

However, this same ability of the immune system presents a serious problem when tissue from another person (or animal) is transplanted into the body. The immune system will ordinarily identify the transplant as foreign and begin to attack it. The attack is carried out by cells using chemical weapons that can kill other cells. This process is known as transplant rejection.

To prevent rejection two different strategies have been used. One is to find a transplant donor who has genetic markers (HLA) that are similar to those of the person receiving the transplant. The more similar the markers, the less likely it is that the immune system will reject the transplant. The other strategy is to administer drugs to transplant recipients that suppress the ability of the immune system to recognize and target transplants for destruction. While these drugs usually work, they have numerous side-effects and can make an individual more vulnerable to infections. Often times both strategies are used.

One potential solution to the problem of transplant rejection would be to create a transplant with markers identical to those of the person receiving the transplant. A persons DNA contains the unique blueprint for that persons body, including the details for the markers (HLA) that are recognized by the immune system. Some researchers are attempting to insert human DNA into cells that are then used to create human embryos. This process is known as cloning that is, artificially producing another organism with DNA that is identical to the DNA of the donor. Cloning has been performed with some types of animals but not with a human being(1). If human cloning is eventually successful, the clone would have markers identical to those of the DNA donor. This would potentially allow transplants to be created with the DNA of the patient, which would be recognized by the immune system as belonging to the body. There would be no potential for transplant rejection and no need for drugs to suppress the immune system.

However, even if cloning is successful, researchers will still need to learn how to stimulate an embryonic stem cell to produce a neuron rather than a skin cell or some other type of cell. Transplanting undifferentiated stem cells runs the risk of creating a tumor, an event which has actually occurred when embryonic stem cells have been transplanted into mice. Furthermore, while finding a source of cells that can differentiate into neurons is one major challenge in developing a cure for spinal cord injuries, there are others (click on the Treatments for the Future link under the Spinal Injury Treatment tab.) Consequently, any effective treatment to repair spinal cord injuries using embryonic stem cells lies years, if not a decade or more, in the future.

Cloning is one example of genetic engineering, an activity in which people manipulate DNA to create organisms that wouldnt otherwise exist in nature. While the first mammal (Dolly the sheep) was cloned in 1997, some clones have had health problems not characteristic of the species (including Dolly), are more prone to have offspring with birth defects, or have much shorter than normal life spans. The long term results of cloning are not known. As a result, ethical issues abound, and particularly when human cloning is the issue.

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Heart cells respond to stiff environments

By JoanneRUSSELL25

5 hours ago Schematic illustrating how mechanical properties of substrates affect where YAP/TAZ protein localization in cardiac stem cells (left) and how this affects stem cell development and function (right).

Proteins associated with the regulation of organ size and shape have been found to respond to the mechanics of the microenvironment in ways that specifically affect the decision of adult cardiac stem cells to generate muscular or vascular cells.

Cell development for specific functionsso-called cell differentiationis crucial for maintaining healthy tissue and organs. Two proteins in particularthe Yes-associated protein (YAP) and WW domain-containing transcription regulator protein 1 (WWTR1 or TAZ)have been linked with control of cell differentiation in the tissues of the lymphatic, circulatory, intestinal and neural systems, as well as regulating embryonic stem cell renewal. An international collaboration of researchers has now identified that changes in the elasticity and nanotopography of the cellular environment of these proteins can affect how heart stem cells differentiate with implications for the onset of heart diseases.

Researchers at the International Center for Materials Nanoarchitectonics (MANA), National Institute for Materials Science (NIMS) collaborated with researchers in Finland, Italy, the Netherlands, Saudi Arabia and the Czech Republic in the study.

They engineered YAP and TAZ proteins that expressed green fluorescent protein so that their location within the cell could be tracked. They then prepared cell substrates from smart biomaterials displaying dynamic control of elasticity and nanostructure with temperature. "Our data provide the first evidence for YAP/TAZ shuttling activity between the nucleus and the cytoplasm being promptly activated in response to dynamic modifications in substrate stiffness or nanostructure," explain the researchers.

Observations of gene expression highlighted the key role of YAP/TAZ proteins in cell differentiation. In further investigations on the effect of substrate stiffness they also found that cell differentiation was most efficient for substrates displaying stiffness similar to that found in the heart.

The authors suggest that understanding the effects of microenvironment nanostructure and mechanics on how these proteins affect cell differentiation could be used to aid processes that maintain a healthy heart. They conclude, "These proteins are indicated as potential targets to control cardiac progenitor cell fate by materials design."

Explore further: Study identifies gene important to breast development and breast cancer

More information: Hippo pathway effectors control cardiac progenitor cell fate by acting as dynamic sensors of substrate mechanics and nanostructure. Diogo Mosqueira, et al. 2014 ACS Nano; DOI: 10.1021/nn4058984

A new study in Cell Reports identifies a gene important to breast development and breast cancer, providing a potential new target for drug therapies to treat aggressive types of breast cancer.

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Stem cell therapy may help severe congestive heart failure

By NEVAGiles23

PUBLIC RELEASE DATE:

13-Mar-2014

Contact: Toni Baker tbaker@gru.edu 706-721-4421 Medical College of Georgia at Georgia Regents University

Augusta, Ga. Researchers want to know whether patients with debilitating heart failure can benefit by having their own stem cells injected into their ailing heart muscle.

The severe condition is ischemic dilated cardiomyopathy, a currently incurable condition resulting from significantly compromised blood flow to the heart muscle as well as heart attacks, which leave the muscle bulky and inefficient and patients unable to carry out routine activities.

"We want to know if stem cell therapy is an option for patients who have essentially run out of options," said Dr. Adam Berman, electrophysiologist at the Medical College of Georgia at Georgia Regents University and Director of Cardiac Arrhythmia Ablation Services at Georgia Regents Health System. "It's a very exciting potential therapy, and these studies are designed to see if it works to help these patients."

Berman is a Principal Investigator on the multi-site study in which stem cells are removed from the bone marrow, their numbers significantly increased by technology developed by Aastrom Biosciences, then injected into multiple weak points in the heart. At GR Health System, the procedure is performed in the Electrophysiology Lab where Berman threads a catheter into an artery from the groin into the heart. Three-dimensional maps of the heart are created to provide a clear picture of its natural geography as well as major sites of damage.

"Everyone's heart is different, their scar burden is different, everything is different," Berman said. From that vantage point, small needles - similar in size to those used for skin testing - are used to make about 12 to 20 strategic injections of mesenchymal stem cells, which can differentiate into a variety of cell types. In this case, researchers hope the cells will improve blood flow and function of the heart.

Half of the study participants receive the stem cell treatment called ixmyelocel-T and the remainder a saline placebo. Patients go home the next day but researchers follow all participants for 12 months to assess heart function and quality of life. GR Health System plans to enroll a handful of patients in the clinical trial.

Treatment options for heart failure include frontline therapies such as diuretics to more extreme measures such as implantable ventricular assist devices and heart transplants.

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Leukemia patient pins hopes on OneMatch stem cell donor registry

By NEVAGiles23

Each day is a gift for Chris Taylor and every phone call could be the one that saves his life.

Thats why the 36-year-old man with acute myeloid leukemia keeps his cellphone within reach, waiting to hear that a stem cell donor has been found and hell get the bone marrow transplant he needs.

Taylor, who was diagnosed in July 2012, has already had two false alarms but is confident a match will become available before its too late.

Getting the call is a miracle in itself. It comes after an online search of unrelated people by the Canadian Blood Services OneMatch Stem Cell and Marrow Network. The registry has access to 22 million potential volunteer donors in 71 countries, strangers prepared to help those like Taylor.

Despite popular belief, family members are matches only 25 per cent of the time, said Mary-Lynn Pride, a patient transplant liaison specialist at OneMatch.

More than 800 Canadians currently await transplants. OneMatch has more than 333,000 registered Canadian donors.

Taylor signed up after a second round of chemotherapy last summer, when doctors at Princess Margaret Hospital advised he needed a bone marrow transplant.

Taylor received the first call last November. The timing was perfect because his cancer was in remission, the only time a transplant can be done.

Two days before he was to be admitted to hospital, Taylor got bad news. The procedure was cancelled because the donor had unspecified medical complications, he said. OneMatch does not say why donors decide to abandon the procedure.

The second call came last month, but the donor withdrew for reasons unknown to Taylor.

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FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering, Etc.

By NEVAGiles23

Course Description: Regenerative medicine focuses on harnessing the power of ones own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs. In April 2006, the U.S. Food and Drug Administrations (FDA) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (HCT/Ps) in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in the industry on how such therapies should be regulated by FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

This 2-day interactive seminar on FDA regulations of regenerative medicine will cover:

-How FDA is currently regulating regenerative therapies and products intended for both human and veterinary use. -The distinction being made between human regenerative products and their regulation as drugs, biologics, devices, and combination products. -The New Drug Application (NDA) and the Biologic License Application (BLA) review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements. -The option for obtaining designation and approval as Orphan Drug Product. -Designing and conducting appropriate clinical trials to support the approval of regenerative therapies. -FDAs regulation of some regenerative medicine products and accessories as Medical Devices. -The Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) being applied by FDA to human regenerative products. -The labeling and marketing of regenerative products and therapies. -The potential for enforcement action and recommendations for mitigating that risk. -The current regulation of veterinary cellular treatments including autologous, allogeneic and xenogeneic cellular products in the United States.

Learning Objectives: Participants who attend this course on FDA regulation of regenerative medicines will leave with a comprehensive understanding of:

-How FDA regulates regenerative treatments and therapies? -The HCT/P Criteria and Minimal Manipulation Standard. -The Drug and Biological Approval Process. -Regenerative Products as Medical Devices. -How to Design Appropriate Clinical Trials? -Applicable cGMPs and cGLPs. -Marketing Exclusivity and Patent Restoration. -Product Labeling, Marketing and Advertising. -FDA and other Federal Agency Enforcement Action. -The Regulation of Veterinary Regenerative Medicine. -The New Animal Drug Application (NADA) Process. -Veterinary User Fees and Waivers.

Who will benefit: This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

-Senior quality managers -Quality professionals -Regulatory professionals -Compliance professionals -Production supervisors -Manufacturing engineers -Production engineers -Design engineers -Labelers and Private Labelers -Contract Manufacturers -Importers and Custom Agents -U.S. Agents of Foreign Corporations -Process owners -Quality engineers -Quality auditors -Document control specialists -Record retention specialists -Medical affairs -Legal Professionals -Financial Advisors and Institutional Investors -Consultants, Inspectors and cGMP Experts

Link:
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering, Etc.

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Bioquark Inc. Announces the Appointment of Dr. Luis Martinez, MD, MPH, Regenerative Medicine and Cell Therapy …

By raymumme

Philadelphia, PA (PRWEB) March 13, 2014

Bioquark, Inc., (http://www.bioquark.com) a company focused on the development of combinatorial biologics for regeneration and disease reversion in human organs and tissues, today announces the appointment of Dr. Luis Martinez, MD, MPH, as VP of Global Operations.

We are honored to have someone with Dr. Martinezs experience join us as we execute on a globalized strategy in regenerative medicine, said Ira S. Pastor, CEO, Bioquark Inc. His broad clinical experience in applied regenerative medicine and cellular therapies make him a very valuable addition to the Bioquark team.

Dr. Martinez is a regenerative medicine and cell therapy specialist with over 10 years of experience in the clinical setting. He is currently the President of Elite Regenerative Medicine Group, a premier treatment and research center specializing in cell therapy applications for therapeutic, regenerative and preventive purposes. Dr. Martinez obtained his medical degree, as well as his Master of Public Health, at the Ponce School of Medicine and Health Sciences, and completed his residency at the prestigious University of Pennsylvania. He also completed a fellowship in biosecurity with the UPMC Center for Health Security. He is currently a clinical instructor at the Ponce School of Medicine and Health Sciences and is a board certified physician. Dr. Martinez also serves as vice-president of the XanoGene Anti-Aging Clinic and is President at Xyrion Medical, a biomedical consulting firm. He is a current consultant for multiple biomedical and pharmaceutical companies and conducts clinical research for various clients in the industry. Dr. Martinez is also a renowned international speaker, speaking at multiple venues for professional and academic organizations and he offers training to physicians in multiple applications of regenerative medicine, including Platelet Rich Plasma (PRP) therapy, adipose and bone marrow stem cell derived harvesting, preparation and therapeutic administration, as well as cytokine, growth factor and peptide therapies.

I am very excited about the biologic candidates being developed at Bioquark Inc. and their very novel approach to human regeneration and disease reversion, which has broad clinical applicability towards a range of degenerative disorders," said Dr. Martinez. "I'm pleased to be joining the team and am looking forward to playing a more active role in this truly transformational platform."

About Bioquark, Inc.

Bioquark Inc. is focused on the development of biologic based products that have the ability to alter the regulatory state of human tissues and organs, with the goal of curing a wide range of diseases, as well as effecting complex regeneration. Bioquark is developing biological pharmaceutical candidates, as well as products for the global consumer health and wellness market segments.

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Bioquark Inc. Announces the Appointment of Dr. Luis Martinez, MD, MPH, Regenerative Medicine and Cell Therapy ...

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Man hoping for third stem cell match after first 2 donors back out

By Sykes24Tracey

Watch the video above:Leukemia patient Chris Taylor loses 2nd bone marrow transplant donor. Angie Seth reports.

TORONTO A 36-year-old leukemia patient is searching for a bone marrow donor for the third time, after his first two donors backed out for medical or unknown reasons.

Chris Taylor was diagnosed with leukemia in 2012. He originally went to Mount Sinai hospital with chest pains and spent several days in the ICU though doctors couldnt figure out what was wrong with him, he said.

But several weeks later, Princess Margaret Hospital found his cancer at the chromosomal level. HE immediately started chemotherapy and it went into remission.

It came back after ten months, he said. I was starting to feel better and the side effects were starting to wear off and then the cancer came back.

They found a match around Christmas of 2013, he said. They started preliminary testing and even got a proposed date but two days before, the donor pulled out.

Unfortunately that donor was medically unfit to donate, Taylor said.

So they went back to searching. They found another donor.

We began again the process of getting ready to go in for the transplant, he said. Unfortunately for unknown reasons that donor had to opt-out of the procedure.

I was disappointed but I dont hold any ill-will or anything like that.

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Man hoping for third stem cell match after first 2 donors back out

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Stem cell donor, recipient get together

By Sykes24Tracey

Richard France has been visiting Pine Island for 18 years. Each winter he escapes the Ohio winters for the sunny warmth of Pine Island for about six months a year.

"In 2008 I was diagnosed when I was 68 years old with acute leukemia," France said. "I underwent treatments for a fair amount of time, 4 or 5 months - chemotherapy. We usually come down in January but that year we were here for March and April."

He continued, "After that I was in remission for three years but then in 2011 we were here in Florida and I got a call from my doctor. He said the cancer had returned and that I needed to get back to Ohio. They recommended that I have a bone marrow transplant and I got on the transplant list. I think it was under a year when I got word that they had a donor. By then they had decided against a bone marrow transplant and were looking for a stem cell donor. It was the day before Thanksgiving that I went into the hospital and I stayed until almost Christmas. On Nov. 30, I got Laurie Burnworth's stem cells."

Laurie Burnworth stem cell donor and Richard France recipient.

PHOTO PROVIDED

A stem cell (blood or marrow) transplant is the infusion, or injection, of healthy stem cells into your body to replace damaged or diseased stem cells. A stem cell transplant may be necessary if your bone marrow stops working and doesn't produce enough healthy stem cells. A stem cell transplant also may be performed if high-dose chemotherapy or radiation therapy is given in the treatment of blood disorders such as leukemia, lymphoma or multiple myeloma.

"I've been donating blood for years," Burnworth said. "I think I may have signed up for this at one of those times I signed up for blood but I really don't remember. It seems one thing led to another and I believe we were matched up in 2008 and they called me. But that's when Richard went into remission and they held off. Then in 2011 they contacted me again and said 'You are the perfect match for this gentleman and if you're still interested we're going to do this.' After extensive testing we went ahead.

"I think a lot of people don't sign up because they think they take the material from the bone," Burnworth continued. "But in my case you just go to the blood bank, which for me was in Rockford, Ill., and sit in a chair and then you just get hooked up like you're donating blood the difference being though is you're hooked up with both arms. One arm collects the blood where it is sent to a centrifuge that separates the platelets and then the blood is returned through the other arm to your body.

"It's really not a bad process," Burnworth said. "It takes a little time but this is the result. For the first year you can correspond with each other anonymously. Then after a year you sign forms releasing the information. It was Christmas 2012 that I got my phone call from Richard. And, of course, I didn't recognize the phone number so I didn't answer but he left a message and I immediately called back. That's when it really hit me and I cried because Richard and his family got to celebrate Christmas. Then this year they got to celebrate their 50th wedding anniversary and I cried again."

"We meant to get together last year but didn't," France said. "My wife urged that we get together this year and here we are. It's been two years since I got my transplant and I've got another three to go before I'm considered cured. I'm getting pretty much everything back and I feel wonderful and I'm so thankful for Laurie. I wish more people would look into donating organs in general."

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Stem cell donor, recipient get together

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