“Here’s to the crazy ones, the misfits, the rebels, the troublemakers, the round pegs in the square holes… the ones who see things differently — they’re not fond of rules… You can quote them, disagree with them, glorify or vilify them, but the only thing you can’t do is ignore them because they change things… they push the human race forward, and while some may see them as the crazy ones, we see genius. One person can make a difference, because the ones who are crazy enough to think that they can change the world, are the ones who do.”
~ Steve Jobs ~
SUNRISE ( CBSMiami ) The clinic, U.S. Stem Cell, has also faced scrutiny after several patients say they were blinded or suffered significant vision loss following treatments at the facility.Jeannine Mallard is one of those patients. She recently spoke to CBS4 News and said she flew from her home in France to South Florida in 2015 to get treatments for macular degeneration. Clinical trials can be inherently risky. “I could not wait doing nothing and
I expected this to improve,” she said.
Mallard says she came to the Hollywood Eye Institute clinic in Cooper City to be treated by Kristin Comella and Dr. Shareen Greenbaum. Mallard paid several thousand dollars to participate in a clinical trial run by a company called Bioheart, the precursor to US Stem Cell. “They said it was sure,” Mallard said. “They said the worst that could happen is there would be no effect so I could not imagine what would happen next.”
What happened next, according to Mallard and her attorney Andrew Yaffa, is a cautionary tale. Immediately after the procedure Mallard began to experience inflammation and pain. According to the Mallard and Yaffa, the procedure involved taking Mallard’s stem cells from her fat tissue, treating the stem cells and injecting them directly into her right eyeball and behind her left eyeball. Mallard said Greenbaum reassured her about the pain she was having. “She said it’s just inflammation, to not last,” Mallard said. “It’s normal.”
It wasn’t normal. Mallard is now blind in her right eye and she suffered significant vision loss in her left eye. Her right eye is noticeably shrinking. “It’s becoming smaller,” Mallard said. “So small it’s dead right now.” CBS 4 News tried to reach Dr. Greenbaum through calls to her office, emails and a visit to her office. She did not respond to our requests. And Mallard is not alone. Attorney Yaffa sued on behalf of two other women who underwent similar procedures
at US Stem Cell.
Court records and a report in the New England Journal of Medicine show that those other patients and a fourth woman experienced similar significant vision problems. Court documents show that in those cases the parties settled the claims. Yaffa alleges in his lawsuit and in an interview with CBS4 News that US Stem Cell preyed on Mallard who feared losing her vision to macular degeneration. “This is human experimentation and they are exploiting patients that are so desperate and vulnerable that they are looking for any hope at all,” Yaffa said.
The Food and Drug Administration is taking action. Last month, the FDA filed a lawsuit to have US Stem Cell stop marketing stem cell therapies that do not have FDA approval. The lawsuit says, “An injunction is necessary to prevent Defendants from experimenting on patients with adulterated and misbranded drugs.” The agency sent Kristin Comella at US Stem Cell a warning letter last year, saying the procedures the clinic is doing need to be regulated
by the FDA like a drug.
The FDA says in this warning that unproven stem cell therapies need to be regulated because if cells are manipulated by a significant amount after their removed, there is a risk of contamination of the cells. But in a series of online videos and speeches, Kristin Comella,
the Chief Science Officer at U.S. Stem Cell, makes it clear she disagrees with the FDA. “We have helped thousands of patients harness their own healing potential and it would be a mistake to limit these therapies for patients who desperately need them,” Comella said.
Comella, who is not licensed medical professional according to the state of Florida and whose background, according to her online biography is in chemical engineering and regenerative medicine with advanced degrees in chemical engineering and stem cell biology, pitched stem cell therapies as a wonder cure, treating everything from serious brain and spinal cord injuries to hair loss. She touts numerous success stories.
“We’ve had patients who were wheelchair bound come out of their chairs,” she said in an online video. “We’ve had patients who were unable to speak able now speaking full sentences telling us about the day they were injured.” But in her speeches there was little discussion of patients like Jeannine Mallard who suffered serious eye damage. We requested an on camera interview with Comella through her public relations firm but we were denied. So, we tracked Comella down in Weston to ask her about the allegations. She said she believes the government should not interfere in a patient’s right to utilize their stem cells.
{ My Cells My Choice }
“It is our goal to protect the rights of patients to use their own stem cells that exist inside their body to promote healing,” Comella said. We asked her specifically about Jeannine Mallard, and others, who suffered vision loss through macular degeneration. “These poor women cannot see,” a reporter said. “They have significant vision loss and they trusted the clinic to do the work for them. Nothing to say to that?”
Comella did not respond and did not want to comment on the Mallard case, citing an ongoing lawsuit filed by Mallard’s attorney. In fact, Comella didn’t want to talk about much — including the FDA lawsuit and the work at U.S. Stem Cell. “So, you don’t want to answer these questions about the clinic and the work that’s being done there and whether it’s safe?” a reporter asked. Comella responded, “I’m gonna ask you to meet with our PR people and continue to reach out to them for additional comments. I’m gonna ask you to turn the cameras off.”
In a statement sent to CBS4 News from the PR company, Comella said, “My entire career has been dedicated to studying and developing treatments utilizing the body’s own natural ability to heal, and I am devoted to helping others achieve optimal health through therapeutic procedures. It is my life’s work to pioneer regenerative medicine and educate the public about its healing potential. I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body.” The company also sent us a link to a page on the U.S. Stem Cell website directly responding to the FDA lawsuit.
You can find that by clicking here.
Dr. Thomas Albini, Professor of Clinical Ophthalmology at Bascom Palmer Eye Institute, University of Miami, treated Mallard and co-authored the New England Journal of Medicine paper on three other patients from US Stem Cell that sustained permanent eye damage from the stem cell procedure. He believes much more study needs to be done before performing
these treatments on people.
“I think it’s really wrong to offer these types of therapies to people when they’re very dangerous and people aren’t aware of the risks involved,” Albini said. “It’s not that there’s something wrong with stem cells or stem cells and eye disease. Stem cells may very well wind up being the cure for a lot of eye diseases. It was the way in which it was studied and the amount of clinical study that went into doing it before it was offered to patients.”
Albini also offered several important pieces of advice for people who might be looking at
stem cell therapies for treatment.
One, if you enroll in a clinical trial you almost never have to pay for it. Patient funded research is seen as a conflict of interest in the medical field, and two, you should ask if the doctor treating you and recommending stem cell therapy has the appropriate medical background to treat the disease or condition you have. “I think its paramount to require clinicians who are going to be doing these types of therapies to have conducted research ahead of time,”
Albini said.
According to the FDA, they have the authority to regulate stem cell products in the U.S. and in most cases, the agency works to “determine the safety and effectiveness of products in well-controlled human studies.” Currently, the FDA says that the only stem cell products that they’ve approved for use in the U.S. are derived from cord blood. The FDA suggests you ask your health care provider if the FDA has approved the stem cell treatment they are recommending for you before agreeing to it.
Jeannine Mallard says she learned of the US Stem Cell clinic through a clinical trial posted on the National Institutes of Health website. Mallard believed that gave the trial legitimacy. There is a disclaimer on the site that the trials listed have not been vetted by the government but Mallard still believes it’s wrong for it to be posted on a government website.
“What makes me really angry is to find this on the National Institutes of Health,” she said. “How can this be listed on such official site, website? I still don’t understand that.” Mallard says her life is vastly different now. She can’t read and relies on friends and family for nearly everything. She recalls often the past two years of doctors in France trying to repair her eye and being unable to. “They did their best but now they could not save it,” she said.
Since the late 1990s, adult stem cells used therapeutically
were not under the control of the FDA and the adult stem cell movement took off. There were complaints from some MDs that the adult stem cell practice should be regulated by the FDA.
The Panama College of Cell Science responded to those outcries with this statement:
The motive in opposing adult stem cell therapy is money. The big institutions want to keep federal funding of embryonic stem cell research at a high level with the promise that cures are “just around the corner” despite the fact that embryonic stem cells will never be useful in any way for patient treatment because they immediately cause tumors when transplanted. (Source)
Dr. Kristin Comella: Stem Cells — An Idea Whose Time has Come!
Adult stem cell therapy is an autologous treatment method. The stem cells are not lab-created. They are only isolated and purified after extracting them from the patient being treated. Injecting them back into that patient powers up the body’s own healing mechanism to overcome chronic ailments. The FDA didn’t and shouldn’t have anything to do with regulating stem cells from one’s own body. That situation has recently been arbitrarily and
suddenly changed.
Around 2014, the FDA started tweaking their guidance rules for stem cell therapy with the purpose of getting new rules made into laws through Congress that could be interpreted according to FDA whims and enforced arbitrarily. Their agenda is to consider adult stem cells as FDA-regulated drugs. During our phone conversation, Dr. Comella explained how the FDA ignored testimonies from adult stem cell practitioners during their 2015 public hearings regarding new guideline proposals.
Then they arranged to create new rules behind closed door meetings that included pharmaceutical industry allies and insiders. The result was that by 2017, the FDA’s hands-off policy with adult stem cell therapy came to a sudden halt after years of highly successful stem cell practice. By 2018, the FDA got nastier with the “the most influential clinician on the subject of adult stem cell therapy” as its target. The FDA started doing inspections of Dr. Comella’s South Florida clinic that are designed for labs that manufacture drugs.
The standards for hospitals and clinics are not as strict as drug manufacturers. Those inspections were inappropriate for a clinic. But those inspections made it easier to create damaging reports. When the inspectors came by, they demanded to go into rooms while treatments were taking place with semi-nude or nude patients, which Dr. Comella prohibited. The inspectors also demanded to view patient medical records. She allowed that after redacting their names on the copies she gave them.
For her actions to protect patients’ privacy, inspectors allegedly cited Dr. Comella for resisting and obstructing FDA inspections. Soon after the inspections, the FDA served Dr. Comella with a lawsuit for practicing medicine with unapproved drugs. The “drugs” were only those stem cell solutions drawn from patients to be used on them. The FDA has allegedly offered to drop the lawsuit if Dr. Comella signed an agreement to stop doing adult stem cell therapy and
no longer promote it.
She refused. She said she has witnessed people leave their wheelchairs for good from this therapy. If Dr. Comella loses this court case, adult stem cell therapy in the USA may be forced out of the country and only be available to those who can afford medical tourism.
In This short 3-minute video was produced interviewing Dr. Comella and some of her patients.
Examining and Comparing the Different Types of Stem Cell Therapy.
Human embryonic stem cell (hESC) therapy has received most of the media’s attention and government support. But it is the most controversial because it involves extracting tissues from terminated human embryos, aka aborted fetuses. In addition to moral and ethical issues, human embryonic stem cell (hESC) solutions create cells so rapidly where they’re injected they lead to cancerous tumors. To avoid that, researchers have to use immuno-suppressant drugs to curb the embryonic stem cells’ tendency toward cancer.
Using pharmaceutical drugs to curb hESC cancer side effect issues leads to other unexplored and unexpected side effects from those patented stem cell solutions. But the profit motive for embryonic stem cell therapies was strong and a lot of government funds had been put into its research. Pharmaceutical companies were motivated because they could patent stem cells created from embryonic tissues.
Bone marrow stem cell therapy was among the first to depart from flawed hESC (human embryonic stem cell) therapies developed over the past two decades. Bone marrow stem cell therapy was the segue into the adult stem cell therapy movement. Bone marrow extractions
are painful, requiring general anesthesia. It’s relatively difficult and expensive compared to adipose (fat) tissue stem cell harvesting. Bone marrow’s high white blood cell count also encourages inflammation, making it counter-productive for patients already suffering from chronic inflammation or autoimmune disorders.
Most importantly, adipose (fat) tissue yields up to 500 times more mesenchymal stem cells than bone marrow sources, according to Dr. Comella. These are potent stem cells that can differentiate into a wide variety of other cell types. Furthermore, the adipose white blood cell count is lower than bone marrow matter. Overactive, confused immune responses attack organs continually and create chronic inflammation and autoimmune diseases. The lower white blood cell count automatically lowers the risk of further inflammation among patients already suffering from chronic inflammation and autoimmune diseases.
The outpatient treatment involves creating a very small and shallow incision that won’t require stitches on an area of skin covering adipose tissue (fat). From there, liposuction can withdraw a portion of the fat. This part of the procedure requires only a local anesthetic. Then what is extracted is spun at high speed in a special centrifuge to isolate the stem cells which are then purified for IV drip delivery or injection into the same patient from whom it was extracted. Total costs range from five to ten thousand dollars or more in some cases.
Dr. Comella and her colleagues’ mission is to get adult stem cell therapy available for everyone. Private and government health insurance providers cover medical treatments that are much more expensive. Why not cover one that would save money with its lower expense and fewer side effects?
Over the years, there have been nearly 12,000 adult stem cell therapies performed in the United States with an over 90 percent success healing rate for mostly joint and spinal conditions as well as heart and lung issues. But the three known adverse side effect cases continually get all the media attention. The Panama College of Cell Science, which helped launch Kristin Comella’s research and development, had this to say about her:
Perhaps the most influential clinician on the subject of adult stem cell therapy, Dr. Comella has been able to quietly develop patient treatment protocols and treat patients via collaborating physicians and health care providers using legal patient-specific FDA guidelines, including studies permitted by Institutional Review Boards, patient-specific stem cell clinical trials, and direct treatments using the patients own stem cells that are harvested and re-injected for therapeutic purposes.
Through Dr. Comella’s leadership, she and her team have trained and certified more than 700 physicians worldwide in adult stem cell therapy. Lori Gregory and Dr. Kristin Comella, world-renowned expert on regenerative medicine using a patient’s own stem cells join to talk about the federal government’s unprecedented attempt to regulate our bodies. This new treatment holds amazing potential, which is why government & industry want to control your body, your healthcare, your informed choice and your liberty.
The interviews below allows the energetic Dr. Kristin Comella to give a thorough and upbeat description of adult stem cell therapy. https://stemcells.nih.gov/info/Regenerative_Medicine.htm