番茄社区

George Gibson remembers turning to his wife after a 2015 procedure at a Florida clinic that he thought would help his failing eyesight.

At the hotel room where they were staying, he went to open his eyes, but he thought his right eyelid was stuck shut.

He asked his wife what was wrong, but she said both eyelids were open.

"Well, that was the first time I realized that I didn't see," Gibson, who is now age 82, told 番茄社区. "I went blind in one eye, immediately coming out of the place."

Gibson had received injections of autologous bone marrow-derived stem cells in hopes it would fix his vision, which was impaired due to both ischemic optic neuropathy and glaucoma. He had the procedure at (then known as Retina Associates of South Florida), a business run by ophthalmologist Jeffrey Weiss, MD, and former ophthalmologist Steven Levy, MD.

Gibson and other patients have raised similar concerns about treatments they received at MD Stem Cells, claiming the procedures did nothing, or in some cases, caused harm.

The company purports to treat a wide array of conditions with adult bone marrow-derived stem cells -- everything from and to including dementia, amyotrophic lateral sclerosis (ALS), and autism.

On top of that, the treatments are pitched as being part of a clinical trial, one that patients shell out as much as $20,000 to participate in.

Those elements have raised the suspicions of physicians and stem cell experts over the years, but the doctors behind the operation have continued, undeterred.

"They're not neurologists," Thomas Albini, MD, an ophthalmologist at the University of Miami's medical school, who has conducted research on eye injuries from unproven stem cell treatments, told 番茄社区. "There's so many things wrong with it. It is what it looks like -- it's total charlatanism."

Questionable Practices

Most stem cell treatments remain experimental today, and physicians generally do not recommend them outside of a legitimate clinical trial.

Weiss and Levy assert that their stem cell treatments are done as part of "FDA-compliant, IRB-approved, and NIH-registered studies." Yet all three points can be debated.

MD Stem Cells has five trials registered on ClinicalTrials.gov:

• The (SCOTS)
• The (SCOTS II)
• The (NEST)
• The (SciExVR)
• The (ACIST)

ClinicalTrials.gov has a disclaimer on its homepage and on each trial page noting that, "Listing a study does not mean it has been evaluated by the U.S. Federal Government."

MD Stem Cells' compliance with FDA rules is also unclear. The agency has tried to get a handle on questionable stem cell treatments by introducing . This guidance tightened criteria around things considered to be a "361" human tissue product -- as opposed to a "351" biologic drug, which requires more substantial regulation.

A more loosely regulated tissue product would have to be "minimally manipulated" -- essentially unaltered -- and only for "homologous use" -- performing the same function in the recipient and donor.

If the product doesn't meet those minimal manipulation/homologous use criteria, an organization investigating a stem cell treatment would need to get an investigational new drug (IND) application approved by the FDA to run a clinical trial of stem cells in various indications.

While the FDA has been more strict about stem cell products derived from a patient's own fat, as it needs "harsh processing to get the cells out before they can be used," things are less clear with autologous bone marrow treatments, according to stem cell expert Paul Knoepfler, PhD, of the University of California Davis.

"In my view, using bone marrow cells to try to treat diverse eye and neurological conditions is non-homologous use," Knoepfler wrote in an email to 番茄社区. "For that reason, I think that bone marrow cells used for such indications should be considered drugs."

Leigh Turner, PhD, executive director of the bioethics program at the University of California Irvine, who has done research on stem cell companies, echoed those sentiments: "[C]laiming to be able to treat people with dozens of diseases, diseases of the eye, and a litany of neurological indications -- that, to me, can't possibly fall in the category of homologous use of bone marrow aspirate."

The FDA told 番茄社区 in an email that it "cannot assess the regulatory status of the 'bone-marrow derived stem cell' product(s) to which you refer. The determination of how a product is appropriately regulated is made on a case-by-case basis, based on many factors."

The agency did, however, reiterate rules about homologous use, minimal manipulation, and added that, "Based on current scientific understanding, the basic functions of bone marrow consist of forming and replenishing the lymphohematopoietic system."

MD Stem Cells has not confirmed if it has an IND from the FDA for any of its trials. 番茄社区 reached out to Weiss and Levy for comment by email and phone. The person who answered the phone number listed on the MD Stem Cells website, when asked about the unanswered emailed questions from MedPage, said, "We're not interested in having a discussion about it," and hung up.

As for having institutional review board (IRB) approval -- a requirement for any clinical trial with humans, to shield subjects from potential harm -- MD Stem Cells uses the International Cellular Medicine Society (ICMS), which Knoepfler has described as "being viewed somewhat skeptically by the stem cell community."

A decade ago, the ICMS was , which found that the group had been taking votes without a sufficient number of members present, and hadn't been keeping good records of members and rules around research protocols.

As for the quality of the trials and their contributions to stem cell science, MD Stem Cells' first eye treatment trial, , lists its enrollment at 300, but there are no papers on the collective group results. Listed results for SCOTS and its second iteration, , are generally small-group case studies, though some include up to 17 patients.

All of the MD Stem Cells trials listed on ClinicalTrials.gov are open-label, meaning there's no formal control group. Indeed, in , the company has played up the appeal of a non-controlled study: with no placebo group, every patient gets to try the treatment.

"If you're trying to develop an evidence base concerning safety and efficacy, you have to design your studies in a way you can actually generate robust, meaningful results, as opposed to just like, sort of a slurry of junk," Turner said.

Patient Complaints

Albini first became interested in loosely regulated stem cell treatments after he saw three patients in the emergency department one weekend who had pain and vision loss following a stem cell procedure at a different clinic, U.S. Stem Cell. He reported on them in the . (The FDA sued U.S. Stem Cell and won its case against the company, on patients.)

Eventually, Gibson, too, visited Albini. While Gibson said Weiss blamed the vision loss on everything but the stem cell procedure -- "He came up with all kinds of reasons. 'Well, your age, it's just coincidence. You know, high blood pressure could do it'" -- Albini thinks the treatment played a role.

Albini said fibroblast cells in the injections can start to live on the surface of the retina, forming a fibrous plaque called an epiretinal membrane, which then contracts. In Gibson's case, he said, it may have distorted his vision rather than completely detached the retina, as happened with Albini's initial patients.

"What's being lost in the gray zone is that they're not really telling [all their] patients how out-there and how unsteady and how dangerous intravitreal and subretinal delivery of the stem cells is," Albini told 番茄社区.

Gibson was outspoken against MD Stem Cells in the media for a time after his treatment in 2015. So was his friend Ahmad Farouki, who met Gibson in the waiting room of the surgical center where they received the injections.

Farouki had the procedure at the age of 45, after living for most of his life with retinitis pigmentosa, a rare genetic disease. Farouki got the procedure after he called Levy. "He started telling me that, 'Yeah, your condition we can fix, and you're going to improve your sight,' and I don't have to worry, but I have to come up with money," said Farouki. "About $20,000."

After the injections, Farouki lost vision in his stronger eye. "I collected the money from my friends and family. I went and did the procedure," he said. "With [retinitis pigmentosa], yeah, we lose vision, but it's over a long, long time. But the minute I woke up, I tried to open my eyes, and I couldn't see anything out of my left eye."

Weiss again blamed the deterioration on his original condition and his age, Farouki wrote in a in 2016. "He [Weiss] had nerve enough to tell me the stem cells were the reason my right eye did not deteriorate," Farouki wrote.

Albini saw Farouki, too, a few months after his procedure with MD Stem Cells. Based on visits and his review of eye exams before and after the injections, Albini said he believed Farouki's vision had also been damaged by the procedure.

Gibson and Farouki wanted to sue Weiss, but then discovered that Weiss was not covered by , a practice known as "going bare." This is illegal in some states, but not in Florida. The practice can in some cases dissuade lawyers from taking on lawsuits they can't collect damages on, according to .

When Gibson went back to the clinic a year later to retrieve imaging of his eyes with a reporter from the BBC, someone from the office called the police on him.

Gibson even went to an FDA public hearing on the use of human tissue and stem cell therapies, determined to make his voice heard. He wore a sandwich board bearing the message, "Drs. Levy, Weiss, and Stem Cells took away my sight!!!" but none of it made a difference.

On a Facebook group where people seek advice and share information about eye treatments, to Weiss and MD Stem Cells. A number of people commented that the expensive procedures -- injections of bone marrow aspirate into both eyes -- did nothing.

One such patient, Thomas Prince, who traveled from Tennessee to Florida for the treatments around the same time as Gibson and Farouki, described to 番茄社区 a similar story to theirs: minimal initial assessment, assurances of successful past results, injections under anesthesia, and little to no follow-up.

Prince, who had vision loss and optic nerve damage due to vasculitis, said he and his wife used money they had saved up to pay for the expensive stem cell treatment billed as a clinical trial.

His impression after the initial screening call with Levy was that securing their payment was the primary goal. "He's the guy that takes the money, and you're supposed to keep him informed of any improvements you got," Prince said.

Prince sent Levy follow-up eye exam reports that he said showed no improvement, but said he received no response.

Weiss and Levy "didn't give a damn" about his results, Prince felt, but he noted that Levy "called right before [the procedure] to make sure we had a credit card payment in."

One patient's wife, Tobey Basista Salem, said her husband had vision loss with macular degeneration and was "so hopeful" for an effective treatment. They read online about MD Stem Cells and after a conversation with Levy and Weiss, discovered her husband would "qualify" for the ophthalmology trial.

She recalled a moment that seemed more fit for a showroom floor than a doctors' office. Weiss was speaking to a patient in the next room, leaving the door ajar while she and her husband waited. "He was telling the guy, 'You see the guy in the next room, I just checked him. He's a candidate. He's doing it. You should do it too.'" Salem said it was as if, "Well, we were lucky we could do it."

Looking back, she said, "I don't know if there was anybody in the room."

A wire transfer and several injections later, Salem's husband and Salem returned home. But nothing got better after the stem cell injections. Her husband's vision has gotten progressively worse. She tried reaching Weiss, and after a brief exchange where he told them to visit their home doctor with any complaints, she tried calling Weiss' office again. "You just couldn't get through to him," she said. "He wasn't answering calls."

"It's just very strange that he didn't want to see anybody after the procedure," she added. If it was a clinical trial, "you'd think that they would want to know the results."

'Selling Snake Oil'

On the MD Stem Cells website, Weiss is listed as the principal investigator of the trials, while Levy is described as the CEO of the company and as study director.

Weiss has an , but he has run into trouble with his professional society.

The American Academy of Ophthalmology (AAO) terminated Weiss' membership in 2021 for allegedly violating their rules after launching an ethics investigation around the stem cell eye trials, an and show.

In its review of records Weiss surrendered to them, which are under seal, AAO found poor documentation, failure to report complications, and research safety problems. He had violated the organization's ethics rules, in part, because of "claims relating to safety, efficacy, and success rates ... not substantiated by the submitted patient data," according to a .

Weiss subsequently sued AAO, claiming that their investigation was illegitimate and would ruin his reputation and his business, but a his lawsuit.

An ophthalmologist by the name of Stephen Levy -- a different spelling from the "Steven" listed on the MD Stem Cells website and LinkedIn -- surrendered his New York medical license in 2004 after the that, among other acts, he ordered excessive tests, falsely represented patient findings, and performed procedures on the wrong eye of a patient. Records show a Stephen Levy with matching credentials surrendered his the same year.

Andrew Yaffa, a medical malpractice lawyer in Coral Gables, Florida, told 番茄社区 that as many as 25 of Weiss' patients have approached him "wanting me to sue him for various promises and representations and procedures that have not come to pass."

Though he said the firm has not taken on these cases (he said the firm wasn't able to identify a specific area of damages that would fit their criteria), "I will tell you, there are lots of folks that are looking at him."

"Weiss was very, very selective in the patients that he takes on," Yaffa explained. "Weiss is selecting patients that are basically already blind to begin with and have little to no vision to lose. And so basically, if he harms them and damages them, it's not like he's done any real damage that I'm able to prove in court."

Neither the Florida Department of Health nor the Florida Department of Agriculture and Consumer Services, which houses the Division of Consumer Services, returned requests for comment by 番茄社区. The Federal Trade Commission declined to comment on stem cell treatments or specific companies.

Other entities with the authority to reign in such treatments have tried. In Florida, where stem cell businesses are especially concentrated, legislators that would establish rules for investigational stem cell treatments, with no luck.

"It was like the Wild West," Florida state senator Lori Berman (D), who sponsored one bill, told 番茄社区. "There was no regulation."

Berman never got a hearing for her bill. "I heard people come to me and say, 'We're using it and why would you stop us from using it?'"

The FDA has filed three high-profile cases against stem cell companies, winning two of them. The agency won its case against , and against .

Last year, however, a federal judge ruled that stem cell treatments from another company, California Stem Cell Treatment Center, were exempt from FDA regulation, as they weren't the same as pharmaceuticals. Knoepfler wrote that the decision might embolden other stem cell companies.

Albini said that he hasn't seen as many patients come into his office with stem-cell treatment-related complications as he did in the past. "Hopefully, people are doing less of it," he said, "but it's still a really difficult thing to go after."

Yaffa said there are still plenty of stem cell companies across the U.S. offering treatments: "Patients are desperate for hope and help, and they're willing to pay out of pocket," he said.

"These companies are selling snake oil, and people are getting hurt," Yaffa added. "And they will, unless and until the FDA finally gets a grip and gets the manpower and the wherewithal to wrap their arms around this."

Comment