Showing posts with label stem cell tourism. Show all posts
Showing posts with label stem cell tourism. Show all posts

Thursday, July 5, 2012

Stem Cell Lawsuit Against Korean Company

Hello folks,
The heat continues to rise here in Michigan, reaching close to a 100 degrees yesterday. 

For the last two  months the heat has been on RNL Bio Co. Ltd., a South Korean stem cell company who is being sued along with 
affiliates - by patients for fraud; related to marketing and administration of stem cells

This case could be a milestone and according to the Knoepfler Lab Stem Cell Blog it might be the first lawsuit of its kind. The complete report written by Leigh Turner can be read online at Health in the global village

RNL Bio Co. Ltd. and its President, Jeong Chan Ra (also known as Ra Jeong-Chan), along with Human Biostar Inc., formerly known as RNL Life Science Inc., and Jin Han Hong, President and Chief Operating Officer of Human Biostar Inc., are defendants in a lawsuit alleging fraud related to marketing and administration of stem cells. The lawsuit, Ben Hang Lee et al v. Human Biostar Inc. et al, was first filed May 21, 2012 in the Superior Court of the State of California, County of Los Angeles. On June 29, 2012, the case was shifted (or “removed”) to United States District Court, Central District of California, Western Division-Los Angeles. Michael W. Fitzgerald is the Presiding Judge.

Celltex Therapeutics, a Texas company involved in experimental stem cell surgery received by Gov. Rick Perry for his back pain in 2011 and recently inspected by the FDA has ties to the Korean company, but is not included in the case. In the article Leigh Turner wrote about the connection and the thousands of individuals who received the stem cell treatments.

RNL Bio is a South Korean stem cell company known for banking adult autologous stem cells and shipping processed, cultured, and expanded stem cells to clinics located in China, Japan, and Mexico. At least 10,000 individuals reportedly have received infusions or injections of adult autologous stem cells at clinics affiliated with RNL Bio. Numerous health researchers and journalists accuse RNL Bio of promoting stem cell tourism to countries with inadequate regulation of stem cells and unlawfully providing clinically unproven stem cell procedures to patients at several South Korean health care facilities. More recently, in the U.S. RNL Bio attracted considerable scrutiny as a result of licensing its stem cell technology to Celltex Therapeutics and both staffing and running Celltex’s controversial stem cell processing facility and bank in Sugar Land, Texas. FDA investigators recently inspected the Celltex biological drug manufacturing facility; the inspection report issued by investigators identified numerous problems with manufacturing practices at the site. In subsequent press release Celltex noted its close ties to RNL Bio, stating, “Celltex’s laboratory is currently operated by its licensing partner RNL Bio (dba Human Biostar), with lab technicians and scientists from RNL’s Seoul, Korea headquarters.” Celltex Therapeutics is not a defendant in Ben Hang Lee et al v. Human Biostar Inc. et al.

Leigh Turner points readers to the journal Nature, for an article on the 10,000 individuals who  reportedly received infusions or injections at the affiliated stem cell clinics.

Korean deaths spark inquiry - Published online 23 November 2010 @ Nature

The controversy over stem-cell tourism, in which patients travel to other countries for unapproved stem-cell treatments, continues to grow. In June, researchers in Thailand reported finding "strange lesions" in a patient who had died following stem-cell therapy for kidney disease ..continue reading....

Full story by Leigh Turner available @ Health in the global village.  

The Stem Cell Industry

Stem cell treatments are becoming a worldwide industry with dubious stem cell clinics offering treatments for everything from ALS, diabetes, autism to cancer. Last year Europe's largest stem cell clinic was shut down after the death of baby.

In the US, there are places that refer people to international clinics for what are claimed to be stem-cell-based treatments.

For instance a clinic in northern Mexico was found to have ties to Arizona. This year reporter Carolyn Jarvis, from an Arizona news station visited a clinic in Puerto Pensaco, Mexico, posing as a patient. Soon the news team learned  Dr. Jesus Gonzales, the physician who infuses the stem cells into patients worked with The Envita Medical Center in Scottsdale. According to the article, Dr. Jesus Gonzales also practiced in New Mexico, before his license was suspended by the state board, for "incompetent to practice medicine."

In the story Gonzales admitted the procedure is experimental and research is in the investigative state. Which is pretty much what most of these clinics say to cover themselves, as they continue to offer unproven stem cell treatments.


Stem cell tourism in China has become a growing but loosely regulated industry. This year China's Health Ministry ordered a stop to unapproved stem cell treatments and clinical trials.

Reuters excerpt;

The Ministry of Health will stop accepting new applications for stem cell programs, a ban that will last until July and comes as China begins a one-year program to regulate the sector better, Xinhua cited a ministry spokesman as saying. 
A growing number of hospitals and clinics in large cities in China have been offering stem cell therapies for treatment of diseases ranging from cancer and Alzheimer's to spinal cord injuries, treatments that are backed by little or no scientific evidence and which are considered at best experimental. 
Some of these involve large general hospitals where patients pay thousands -- or even tens of thousands -- of dollars for treatments that are advertised online, which attract both Chinese patients and those from overseas, sparking what experts say is a dubious type of medical tourism

Stem Cell Tourism

This brings us to a company called MediCAREtourism, a travel and hospitality company located in Asia, in the an Arab state of Oman, who offers medical packages through a division of the company called Travel Point LLC. These packages include a "Stem Cell Treatment Package" for foreign travelers visiting Asia and the far east (Korea, Malaysia, and Singapore) which runs from May through July.

Excerpt from the companies website;
Travel Point LLC also announced that in association with Ming Medical Services, they will be offering free medical consultation and general health checkups for all their passengers travelling to Thailand & Malaysia for a holiday.
The health checkups will be held at accredited hospitals like Paulo Memorial Hospital in Bangkok (Thailand), Prince Court Medical Centre in Kuala Lumpur (Malaysia) and Sime Darby Medical Centre Ara Damansara in Selangor (Malaysia). Mr. Aslam Sayed Mohamed, Manager, MediCAREtourism, said, "The popularity of Stem Cell Treatment is fast growing in the medical world today and many people have found 100% benefit from this therapy. In addition to free checkups for our customers holidaying in the Far East, we are also offering very affordable Stem Cell Therapy packages to Malaysia and Thailand." 
Stem cell treatments are a type of intervention strategy that introduces new cells into damaged tissue in order to treat disease or injury. Many medical researchers believe that stem cell treatments have the potential to change the face of human disease with minimal risk of rejection and side effects. Medical researchers anticipate that adult and embryonic stem cells will soon be able to treat cancer, Type 1 diabetes mellitus, Parkinson's disease, Huntington's disease, Celiac Disease, cardiac failure, muscle damage and neurological disorders, liver cirrhosis and most importantly spinal injuries/paralytic cases from road accidents.

Stem Cell Research

The lawsuit may turn patients back to valid research, and creditable stem cell researchers, like Dr. Irving L Weissman the Director of the Stanford Institute of Stem Cell Biology and Regenerative Medicine. The highly regarded Dr. Weissman recently wrote about current stem cell research, the FDA, private cord blood banks, and the fine line between fraudulent practices and questionable ones that use the stem cell label, but are not in fact stem cell therapies;

There is also a fine line between these clearly fraudulent practices and questionable ones that use the stem cell label, but are not in fact stem cell therapies. For example, cultures of adherent cells from bone marrow, cord blood, or adipose tissue are regularly claimed to be mesenchymal stem cells (MSCs), but in such cultures true stem cells that both selfrenew and differentiate to mesenchymal fates such as bone, cartilage, fibroblasts, and adipocytes are rare. Mesenchymal stromal cells, as a population, may contain cells that produce immunomodulatory and/or angiogenic factors, but are not sufficiently purified or defined to be a characterized entity for research or clinical transplantation. Finding markers that help define these populations was an important step (Dominici et al., 2006),but until there is a better understanding of how many of these cells can self-renew and give robust regeneration, I do not think they should be called stem cells. 
More from Dr. Weissman ;
Stem cell therapies have the potential to revolutionize the way we practice medicine. However, in the current climate several barriers and false assumptions stand in the way of achieving that goal.  
The first two precepts of the modified Hippocratic Oath, which all M.D. graduates pledge are, in paraphrase: first, do no harm; and second, the primary obligation of a physician is to the health of the patient (to which I add ‘‘and future patients’’), and a physician will not let issues of race, creed, religion, politics, or personal ethics to stand between the patient’s health and his/her actions.  
The stem cell field, probably more than any I know of in medical science, is plagued by failures to act responsibly on both precepts. While I am usually an optimist, I must admit that there is a possibility that we will continue to be in the Dark Ages of medicine for quite some time. I fear that therapies using purified tissue and organ-specific stem cells—the only self renewing cells in a tissue or that can regenerate that tissue or organ for life—will remain elusive. Before I go further, just think about that statement: regenerate that tissue or organ for life. No pharmaceutical, no biotech-developed protein, and no other transplanted cells can do that. If we can deliver purified stem cells safely and effectively as a one-time therapy, we can change medicine,especially for diseases that drugs and proteins can’t touch. Moreover, if we manage the costs and charges carefully,this form of therapy could lower overall health care costs dramatically.

Read the full article here.

 Hopefully, desperate patients will walk away from these worldwide clinics, and realize stem cell treatments are unproven and at worst dangerous.

Thursday, April 12, 2012

China’s stem-cell rules go unheeded

Published in the journal Nature is a report on the unapproved stem-cell treatments and clinics in China. The author David Cyranoski writes that the stem cell trade in China is still quite prevalent despite stronger regulation by the Chinese health ministry.

Health ministry’s attempt at regulation has had little effect.

Saturday, January 14, 2012

Arizona clinic linked to illegal stem cell treatments

TUCSON, AZ (KOLD) - Stem cell treatments are sometimes seen as miracle cures for a variety of serious diseases. One day, that could be true. For now, most researchers say there is no clinical proof that they work; but clinics around the world still offer the service. A clinic in northern Mexico is one of those-- and it has Arizona ties.

Continue Reading @ News 13

Monday, January 9, 2012

Examining the dangers of stem cell tourism

This “60 Minutes” segment tells the heart-breaking story of one family’s experience at a Mexican clinic, where they sought treatment for their three-year-old son’s cerebral palsy.

Read more at Scope

*Takes a moment to load.....

Related: China halts unapproved stem cell treatments
Associated Press January 10, 2012 02:23 AM (01-10) 02:23 PST BEIJING, China (AP) --
China's Health Ministry has ordered a stop to unapproved stem cell treatments, which have become a growing but loosely regulated industry in the country.
The ministry said Tuesday it stopped accepting applications for procedures until July as it tries to bring the industry under control with a yearlong campaign to halt unauthorized stem cell therapy trials.
Regulations on stem cell treatments are lighter in China compared to other nations. The country is seen as a last hope for people suffering from serious medical problems ranging from cancer to spinal cord injuries.
Patients, including some from overseas, can pay tens of thousands of dollars in a bid to restore back functions or sight.

Thursday, July 7, 2011

Podcast;Stem Cell Tourism in the U.S.

For more information on stem cell research visit the Knoepfler Lab Stem Cell Blog  

This Week in Stem Cells with Dr. K. Podcast

Paul Knoepfler at UC Davis
New Podcast;
Listen Here

From The Knoepfler Lab Stem Cell Blog  
5 Topics
–Stem Cell Tourism in the U.S.
–Article in the Hill by stem cell opponent
–Stem cell hype on aging
What Are Stem Cells?
The Knoepfler Lab Stem Cell Blog  now has "What Are Stem Cells" available in the following languages:
什麼是幹細胞? ), Spanish (¿Qué son las células madre?), PortugueseO que são células tronco?),  Polish (Co to są komórki macierzyste? ), Farsiسلولهای بنیادی چه هستند؟ ), Russian ( Что такое стволовые клетки? ),  Japanese (幹細胞ってなに? ), RomanianCe sunt celulele stem? ), and English (What are stem cells?).

Thursday, June 30, 2011

Stem-cell scientists grapple with clinics;Educating patients about unproven treatments

Nature today has an article written by Heidi Ledford discussing the worldwide rapid increase of stem-cell clinics and the dangers of these unproven treatments.

Scope has a nice write up on the article by Eva Valenti, she writes;

Regenerative medicine such as stem cell therapy has cast a ray of hope into many patients’ lives. Stem cell clinics, however, do not always offer patients the most effective treatments. According to a recent Nature article:
Many of the treatments such clinics offer — injecting a patient’s own stem cells back into his or her body in a bid to treat conditions ranging from Parkinson’s disease to spinal-cord injuries — are at best a waste of money, and at worst dangerous. “There’s real potential to damage the legitimacy of the field,” says Timothy Caulfield, who studies health law and policy at the University of Alberta in Edmonton, Canada.
The potential danger of these clinics is clear: In May, Europe’s largest stem-cell clinic was shut down after its treatments were linked to a child’s death....Please do go read the more at Scope and the original article from Nature.

Related on this blog; Stem Cells; Searching For A Cure " When It Becomes Dangerous"

Monday, May 30, 2011

Stem Cells; Searching For A Cure

A few days ago I ran across an interesting article at Stanford Medicine Magazine entitled; "Peddling hope". The author Krista Conger wrote in detail about desperate and dying patients paying an exorbitant amount of money for injections of mysterious concoctions of "cells" which apparently cure just about every ailment known to man. These therapies are promoted by unscrupulous enterprising entrepreneurs through numerous websites online. The informative article sheds a light on the unfortunate patients who travel abroad to these facilities dubbed "stem cell clinics" searching courageously for a cure. The author writes;
“Harm is being done at a lot of levels,” agrees Loring. “But on the list of things that offend me, the false hope they offer to patients is at the top.”
But the hope is cleverly packaged. “These clinics never promise a patient will be healed,” says Sipp. “They’ll say things like, ‘most patients experience an improvement.’ And, when you’ve spent a lot of your own money, or money that was given to you by friends or relatives, the incentive to report that the treatment helped is very strong. There’s a lot of room for the placebo effect.”
“It’s a worldwide industry,” says Sipp, who estimates there are about 300 clinics that offer what they claim to be stem-cell-based treatments for everything from autism to diabetes, from ALS to cancer. “And recently we’ve been seeing a growing complement of places in the United States that either refer people to nearby international clinics in Mexico or the Dominican Republic for the treatment, or even perform procedures domestically.”

By tracking the number of patients some of the bigger clinics state they have treated, Sipp has concluded that tens of thousands of people may have received unproven stem cell treatments worldwide during the past decade, which indicates a market size approaching $1 billion.

Please do read the full article here.

In Germany a clinic offering experimental stem cell injections was shut down in August 2010 because of the death of an 18-month-old boy after a brain injection. The clinic "XCell" also has a clinic in Dusseldorf and one in Cologne,Germany although both clinics are now closed. Here is the article;
Europe's largest stem cell clinic, which is at the centre of a scandal over the death of a baby given an injection into the brain, has been shut down.

08 May 2011

The closure of the XCell-Center in Dusseldorf follows an undercover investigation by The Sunday Telegraph into its controversial practices, which attracted hundreds of patients from the UK. The clinic charged patients up to £20,000 for stem cell injections into the back and brain despite a lack of scientific proof that the treatments actually worked.

Experts in stem cell research had accused the clinic of preying on vulnerable patients, desperately seeking a cure for such illnesses and diseases as cerebral palsy, multiple sclerosis, autism, Parkinson's, Alzheimer's, heart disease, diabetes and spinal cord injuries.

While most other European countries - as well as the US, Canada and Australia - have banned stem cell treatments unless shown to be safe and effective, XCell had exploited a loophole in German law allowing it to charge for the experimental procedures.

But last week, the clinic suddenly announced it had ceased carrying out operations due to what it described as legal changes in Germany. In a posting on its website, XCell said last week: "Due to a new development in German law, stem cell therapy is currently not possible to perform at the XCell-Center. Regretfully for this reason, we must cancel your appointment until further notice. We will notify you for further updates about the matter."...full story here.

This "60 Minutes" show previewed in 2010, I remember watching the it with my friend, she passed from ALS six months after being diagnosed. You can view part two of the video here.
21st Century Snake Oil, Part 1

September 12, 2010 5:00 PM

"60 Minutes" hidden cameras expose medical con men who prey on dying victims by using pitches that capitalize on the promise of stem cells to cure almost any disease. Scott Pelley reports


Follow Up From U-M

Sean Morrison, director of the U-M Center for Stem Cell Biology

ANN ARBOR, Mich. — Patients should be wary of claims made by the operators of stem cell clinics outside the United States who offer unproven and potentially dangerous disease treatments, University of Michigan researcher Sean Morrison said during a segment of the CBS program “60 Minutes” that aired Sunday night.

“There are clinics that have been set up in countries with unregulated medical systems that are making claims that are not based on sound scientific and medical evidence,” said Morrison, director of the U-M Center for Stem Cell Biology.

“People who claim that they can cure diseases in the absence of strong scientific evidence are selling snake oil and preying on the hopes of desperate patients,” Morrison said during an interview conducted after the “60 Minutes” crew visited his Life Sciences Institute laboratory.
Clinics offering unproven stem cell therapies have arisen in countries such as China, Russia and Mexico. In many cases, there is little or no scientific evidence to support the effectiveness of treatments offered by these clinics, Morrison said. Yet patients are charged large amounts of money for the therapies, based on the promise that bone marrow or umbilical-cord-blood stem cells can cure their disease.
Political opponents of embryonic stem cell research in the United States have claimed that bone marrow or umbilical-cord-blood stem cells can cure more than 70 diseases. Morrison said this claim is inaccurate: To date, bone marrow and umbilical-cord-blood stem cells have only been proven effective for the treatment of blood and immune system diseases.
“If your doctor doesn’t have compelling reason to believe that your disease can be treated effectively with the therapy that is being offered, and if there’s no compelling evidence in the scientific literature that this treatment really is a cure, and if it hasn’t been the basis of sound clinical trials that are open to the light of day and replicated in independent clinics, then there is reason to be skeptical, and you should be very cautious about seeking treatment in those clinics,” Morrison said.
These clinics operate outside of the United States because the U.S. Food and Drug Administration would prevent them from making these claims or offering their therapies in the this country, due to the lack of evidence supporting the safety or efficacy of the therapies, Morrison said.
“The unproven therapies are not sold to patients in the United States because medical care, stem cell research, and human-subjects research are tightly regulated here,” he said.
Clinical trials are being launched now in this country to test whether various types of stem cells can reduce the symptoms of amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease.
Dr. Eva Feldman, director of the U-M’s A. Alfred Taubman Medical Research Institute, will test whether implantation of neural stem cells benefits ALS patients. These studies are promising. But until approved clinical trials like this one have been completed, it will remain unknown whether stem cell transplantation can help these patients, or what kind of stem cell is most effective.
“Stem cell research offers exciting new opportunities to cure disease, and promising research is being done in many countries throughout the world,” Morrison said. “However, years of additional research will be required to determine which diseases can be treated effectively, and how. Until that research is done, and the safety and effectiveness of new therapies are confirmed in clinical trials, there is no basis on which to represent potential new therapies as cures.”


If you want to learn more about Stem Cell Research; Click Here

These publications and references will provide a general understanding of stem cells and how they work..

Frequently Asked Questions (FAQ)

Answers to commonly asked questions on stem cell science.


Refer to our glossary for definitions of scientific terms.

Stem Cell Facts

This downloadable brochure provides an introduction to stem cell research and contains a short glossary of commonly used terms.

Stem Cell Briefings

Read about advances in stem cell research.