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.

China

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.