The tempest on stem cell treatment

Medical Files By Rafael Castillo M.D. Philippine Daily Inquirer

The stem cell plot thickens, and the controversy on the inappropriate use and gross misuse of this innovative treatment by some practitioners has seemingly reached tilting point.

Whole-page advertisements were published in major dailies stating in strong terms the sentiments and joint position of various medical organizations and subspecialty societies, most of which are under the umbrella of the Philippine Medical Association.

Curiously and ironically, the alliance was obviously against the newly formed stem cell society, the officers of which are composed of past PMA presidents.

The Professional Regulatory Board of Medicine also issued its position statement two weeks ago in its website.

In a keynote speech delivered during the mid-year convention of the Philippine Society of Stem Cell Medicine recently, Health Secretary Enrique T. Ona described the controversy as pitting the supposed medical scientists, the freewheeling practitioners and the regulatory arm of government against each other.

Challenge

At the end of his speech, Dr. Ona offered what the various groups need to do. The challenge, I believe, among us seemingly competing forces is to sit down and craft a path of consensus, taking in consideration the most fundamental tenet why our profession exists: to save life, to alleviate pain, to do no harm.

We have written about our concerns on stem cell therapy several times in this column (7/14/12; 8/4/12, and 5/24/13). We knew that sooner or later there will be an outrage among legitimate health advocates and concerned medical organizations about the exploitation and inappropriate administration of this innovative but yet experimental treatment.

The therapy is indeed very promising, which, unfortunately, is being exploited by some unscrupulous clinics, even beauty spas and parlors. They offer it to the public, giving everyone the impression that its already tried and tested, charging a hefty sum of money running into millions of pesos for a course of stem cell treatment.

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The tempest on stem cell treatment

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Vet-Stem, Inc. Founder and CEO, Robert Harman, DVM, Invited to Speak at the Adult Stem Cell Therapy and Regenerative …

Poway, California (PRWEB) August 15, 2013

Robert J. Harman, DVM, Chief Executive Officer of Vet-Stem, Inc., a leading Regenerative Veterinary MedicineTM company located in San Diego, California, has been invited back to speak at the Adult Stem Cell Therapy and Regenerative Medicine Conference in Cleveland, Ohio August 19-21, 2013. The conference is presented by The National Center for the Regenerative Medicine (NCRM), Case Western Reserve University (CWRU), Cleveland Clinic (CC), and University Hospitals Case Medical Center (UHCMC) to bring together a global perspective on regenerative medicine and adult stem cell therapy.

Dr. Harman is scheduled as the first speaker of Session II titled Disease Models for Adult Stem Cell Therapy, and his presentation is One Medicine Natural Veterinary Disease Models.

He stands alone in his expertise in the field of Regenerative Veterinary Medicine among the 273 attendees from 100 institutions in 17 countries that make up the conference. Dr. Harman draws his knowledge from more than 10,000 horse, dog and cat patients treated over the last 10 years in both the U.S. and Canada using proprietary Vet-Stem technology.

Dr. Harman is sharing the podium with Case Western Reserve Universitys own Dr. Arnold Caplan, and revolutionary regenerative medicine companies such as BioTime, Terumo BCT, STROMALab, and Pfizer. Dr. Caplan, a technology pioneer in cell-based therapies in Regenerative Medicine, is a scientific advisor to Vet-Stem, Inc.

About Vet-Stem, Inc.

Vet-Stem, Inc. was formed in 2002 to bring regenerative medicine to the veterinary profession. The privately held company is working to develop therapies in veterinary medicine that apply regenerative technologies while utilizing the natural healing properties inherent in all animals. As the first company in the United States to provide an adipose-derived stem cell service to veterinarians for their patients, Vet-Stem, Inc. pioneered the use of regenerative stem cells in veterinary medicine. The company holds exclusive licenses to over 50 patents including world-wide veterinary rights for use of adipose derived stem cells. In the last decade over 10,000 animals have been treated using Vet-Stem, Inc.s services, and Vet-Stem is actively investigating stem cell therapy for immune-mediated and inflammatory disease, as well as organ disease and failure. For more on Vet-Stem, Inc. and Veterinary Regenerative Medicine visit http://www.vet-stem.com or call 858-748-2004.

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Vet-Stem, Inc. Founder and CEO, Robert Harman, DVM, Invited to Speak at the Adult Stem Cell Therapy and Regenerative ...

NIH joins opposition to charging patients for experimental stem cell therapy

By: Jet Villa, InterAksyon.com August 16, 2013 8:24 AM

InterAksyon.com The online news portal of TV5

MANILA, Philippines -- (UPDATE - 10:12 a.m.) A consultant of Secretary Enrique Ona resigned Friday, calling the Health chiefs position that patients undergoing experimental stem cell therapy should pay unacceptable.

Dr. Anthony Leachon, who is in Davao City, said he emailed his resignation letter to Ona.

It is with deep regret that I'm resigning asDepartment of Health consultant for non-communicable diseases effective today (Friday). I have been privileged and honored to be a part of your administration even as a one peso a year consultant. I value our friendship and camaraderie which started years ago, Leachon, vice president of the Philippine College of Physicians and Onas consultant for non-communicable diseases, wrote.

Because his position is directly opposed to Onas, Leachon told the Health secretary, I believe I have lost your trust and confidence and I might not be effective serving the DOH and fighting the PCP and medical societies ' cause in the service of the Filipino patient.

Leachon was Onas consultant for non-communicable diseases since November 2011.

Ang pinaka-hindi ko nagustuhan ay yung sisingilin ang pasyente kahit clinical trial pa lang. Yon ang unacceptable sa akin (What I disagree with most is charging patients even if what they undergo are just clinical trials. That is unacceptable), Leachon said.

His resignation came as the National Health Institute, the research arm for health sciences of the University of the Philippines-Manila, joined the growing opposition to the Health secretarys stand on experimental stem cell therapy.

Leachon, a cardiologist at the Manila Doctors Hospital, called Onas position a complete violation of the Code of Ethics (for doctors) and being the secretary of health, alam niya dapat yon (he should know that). This is not a sign of ignorance, pero siguro may mga taong iba ang sinasabi sa kaniya (but there may be people telling him otherwise).

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NIH joins opposition to charging patients for experimental stem cell therapy

Consultant quits over DOH chief's stand on stem cell therapy

By: Jet Villa, InterAksyon.com August 16, 2013 8:24 AM

InterAksyon.com The online news portal of TV5

MANILA, Philippines -- (UPDATE - 10:12 a.m.) A consultant of Secretary Enrique Ona resigned Friday, calling the Health chiefs position that patients undergoing experimental stem cell therapy should pay unacceptable.

Dr. Anthony Leachon, who is in Davao City, said he emailed his resignation letter to Ona.

It is with deep regret that I'm resigning asDepartment of Health consultant for non-communicable diseases effective today (Friday). I have been privileged and honored to be a part of your administration even as a one peso a year consultant. I value our friendship and camaraderie which started years ago, Leachon, vice president of the Philippine College of Physicians and Onas consultant for non-communicable diseases, wrote.

Because his position is directly opposed to Onas, Leachon told the Health secretary, I believe I have lost your trust and confidence and I might not be effective serving the DOH and fighting the PCP and medical societies ' cause in the service of the Filipino patient.

Leachon was Onas consultant for non-communicable diseases since November 2011.

Ang pinaka-hindi ko nagustuhan ay yung sisingilin ang pasyente kahit clinical trial pa lang. Yon ang unacceptable sa akin (What I disagree with most is charging patients even if what they undergo are just clinical trials. That is unacceptable), Leachon said.

His resignation came as the National Health Institute, the research arm for health sciences of the University of the Philippines-Manila, joined the growing opposition to the Health secretarys stand on experimental stem cell therapy.

Leachon, a cardiologist at the Manila Doctors Hospital, called Onas position a complete violation of the Code of Ethics (for doctors) and being the secretary of health, alam niya dapat yon (he should know that). This is not a sign of ignorance, pero siguro may mga taong iba ang sinasabi sa kaniya (but there may be people telling him otherwise).

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Consultant quits over DOH chief's stand on stem cell therapy

FDA sets deadline for stem cell registration

Manila, Philippines -- The Food and Drug Administration (FDA) ordered that all human cells, tissues, and cellular and tissue-based products, or HCT/P's, should be registered with the agency before August 31.

Acting FDA Director General Kenneth Hartigan Go said based on a circular issued last month that required all stem-cell products be registered in the country.

"Accredited and licensed facilities dealing with HCT/P's must file their applications for registration at the FDA before August 31, 2013. Otherwise, these products shall be considered unapproved and unauthorized for use," according to the FDA circular.

The FDA said it recognizes three applications of stem cell therapy. These are hematopoietic stem cell transplantation, corneal resurfacing with limbal stem cells, and skin regeneration with epidermal stem cells.

Go said all researches dealing with HCT/P's and the propagation of such other than their approved use are all considered clinical investigations and will have to comply with the existing FDA process and guidelines.

The FDA vowed to go after those perpetuators who endanger the public through the use of unauthorized stem cell products.

"Strict compliance is mandatory. FDA will pursue perpetrators who expose the Filipino public to the dangers of unapproved human cells and cellular-based products and will ensure that they are punished to the full extent of the law," according to the circular.

Report Stem Cell Failure

Meanwhile, the FDA asked patients who underwent stem cell treatment and suffered adverse reactions to submit a report online.

"Those who have availed themselves of such products or therapies and have experienced any untoward event or side effect or treatment failures as well as those currently availing such are highly encouraged to submit reports through the FDA website at http://www.fda.gov.ph under eReport and ADR (Adverse Drug Reaction) Report Section," FDA Advisory No. 2013-023 said.

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FDA sets deadline for stem cell registration

Stem Cell Treatment Helps Ailing Dogs

DOVER-FOXCROFT, Maine (NEWS CENTER)-- Some veterinarians in Maine are now treating dogs that have joint pain with a procedure that didn't exist not long ago: a specialized type of stem cell therapy.

At Foxcroft Veterinary Services in Dover-Foxcroft, the vets remove the stem cells from a dog's fatty tissue and re-inject them into the area that needs treatment.

The procedure takes only a day, and is much less invasive than knee or hip replacement.

The therapy also works on other pets, such as cats and horses.

This type of treatment is not the same embryonic stem cell research which has generated controversy. Experts say they are just taking dormant stem cells already present in a dog's body, and putting them to better use.

"We're just taking fat out, which most dogs have an abundance of," says Adrienne Cromer, a lab tech at MediVet, the creators of the specialized process. "We're getting the stem cells out, activating them so that the can proliferate and differentiate and go to the areas of the body where they are needed and do the healing."

Coastal Cat and Feline in York and the Yarmouth Veterinary Center already offer this type of one-day stem cell treatment.

For more information on how this procedure works, visit http://www.medivetamerica.com.

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Stem Cell Treatment Helps Ailing Dogs

Solon calls for probe into stem cell therapy

by Buena Bernal Posted on 08/15/2013 7:59 PM |Updated 08/16/2013 12:05 AM

PROBE STEM CELL THERAPY. Rep Paulino 'Doy' Leachon files a resolution to probe the conduct of stem cell therapy in the Philippines. Photo grabbed from islandsentinel.com

MANILA, Philippines - Rep Paulino Salvador "Doy" Leachon of Oriental Mindoro's 1st district filed on Thusday, August 15, a house resolution calling for a congressional inquiry in aid of legislation on the conduct of stem cell therapy in the country.

House Resolution 215 was filed a day after Leachon's scheduled privilege speech, calling for the resignation of Health Secretary Enrique Ona over the cabinet official's stand on stem cell therapy.

READ: Leachon asks Ona to resign over stem cell issue

The 40-year-old lawmaker also urged concerned government agencies to step up their regulatory oversight. These agencies include the Department of Health (DOH), the Food and Drug Administration (FDA), and the Professional Regulation Commission (PRC).

First attempt to regulate

Government regulation of stem cell treatment is still in its infancy stage, with the guidelines for accreditation of facilities released only in March.

It is DOH's first attempt at regulating the practice, despite the therapy having been administered by Filipino physicians for years now.

The types of stem cell treatment that are allowed, prohibited, and restricted (i.e. allowed but with limitations) in the facilities to be accredited by August 31 are listed in the released guidelines.

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Solon calls for probe into stem cell therapy