Legal

Cease & Desist

Regenerative medicine is a very competitive field, and Chara Biologics makes tremendous effort in staying compliant with FDA regulations, and be upheld to the highest standards of the industry. However, some interest groups mounted vicious and defamatory attacks against Chara and its founder/CEO Joy Kong, MD. Dr. Kong thus had to respond with a legal cease and desist letter to Chris Centeno, MD.

1) First of all, Chris Centeno tried to attack Dr. Kong’s credibility, referring to her as “a psychiatrist,” when she is a triple board-certified physician who has expertise in 3 specialties: psychiatry, addiction medicine, and anti-aging & regenerative medicine. Centeno also made false accusations against Dr. Kong, including ludicrous “scamming the elderly” reference. This is clearly ill-intentioned and groundless.

2) Chris Centeno made statements in his blog “I call this practice the research bait and switch,” referring to the clinical studies Dr. Kong referred to. He attacked Dr. Kong’s integrity and capability, and said “Because she’s out there advertising herself as an expert and trying to educate doctors via YouTube presentations. Regrettably, she makes many common rookie mistakes in that effort.” On the contrary, Dr. Kong provided a vast amount of data, and just because some of the studies used expanded cells, it did not make those studies invalid as a reference point for the type of cells contained in Chara products. Hundreds of such clinical studies exist using the exact type of cells. It is ironic because Dr. Centeno’s entire operation in the Cayman Islands relies on culture-expanding bone marrow derived stem cells. It is convenient to do so overseas to side-step FDA rule which prohibits cultural expansion of cells for clinical use without a drug license. Cell expansion does change property of the cells, resulting in decreased potency and changes in cell characteristics, well-documented in the scientific literature.

3) Centeno claimed that said there’s no comparison between umbilical cord products and bone marrow products, when clearly in Dr. Kong’s presentations/lectures direct comparative studies illustrating the differences were presented.

4) Centeno accused Chara of claiming that the Chara product can treat various “conditions.” Unfortunately, if he ever clicked on any of those conditions, he would see that all it listed was an excerpt of a clinical study that discusses cell therapy results regarding that condition, with absolutely no mention of Chara products or any subsequent claims.

5) Lastly, to dispel a common misconception propagated by certain groups including Centeno’s group. Chara products DO contain live cells, proven by unbiased 3rd party testing results. And no, just because there are live cells, it does NOT make the product illegal, as some people seem to believe. The FDA never prohibited allogeneic products from having live cells, it only states that to be used as a Section 361 product (without the need to go through drug approval process), the effect of the product cannot rely on “metabolic activities of live cells.” In fact, Chara is actively involved in stem cell research, and would like to contribute to the understanding of the effects of the metabolic activities of live cells, and such research will be conducted under IND studies. Chara intends to stay at the forefront of regenerative medicine, promote evidence-based medicine, and help moving the field forward on solid foundation.

Chara will not tolerate vicious attacks by people like Chris Centeno. This is why the cease and desist letter is published here for people’s reference.

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