Giostar, a La Jolla firm that pitches stem cell treatments to desperate patients willing to travel to Mexico to receive them, likes to portray itself as a cut above the rest.
The so-called Global Institute of Stem Cell Therapy and Research boasts that its medical advisory board comprises “luminaries from Harvard, University of California, San Diego (UCSD), University of California Irvine (UCI)” and other leading institutions. It says on its website that its founder, Anand Srivastava, is “credited with setting up the stem cell research labs at top research institutions in [the] US including Salk Research Institute, Sanford-Burnham Institute, UCI, UCSD.”
That could give prospective patients confidence that they were in sound medical hands. But three prominent scientists listed as board members say they have no connection with Giostar, and have repeatedly asked for their names to be removed from its website. Of 11 others listed as members of the advisory board as of Jan. 8, nine could not be reached or did not return calls or emails. One confirmed that he was a board member but referred questions to Giostar. Another acknowledged that he was a member, but said the board had never met and he had only exchanged phone calls with Giostar principals.
I think whatever claims they’re making about treatments are wrong, or certainly can’t be validated to my satisfaction.
The institutions where Srivastava says he set up stem-cell research labs dispute his claim; they and other institutions where Srivastava says he held faculty positions say those claims are untrue.
In a 2018 news release, Giostar, which Srivastava launched in 2008, calls itself “an established leader” in the stem cell field, “offering cutting-edge regenerative therapy options for sports injuries, joint arthritis, and additional degenerative conditions.”
In an interview at the firm’s rented La Jolla quarters, Srivastava and Giostar Chief Executive Deven Patel said the firm charges up to $17,000 for a treatment involving up to three injections of stem cells, generally extracted from the patients’ fat cells. They say the company has treated 10,000 patients over 10 years and continues to treat about 1,000 a year in Mexico or India, outside the jurisdiction of the U.S. Food and Drug Administration, which has issued warnings to U.S. clinics that many treatments using stem cells violate U.S. law. Patients also can receive “rejuvenation” treatments with stem cells at a clinic outside Chicago.
That caught the attention of Nielor Neto, a South Boston business owner who was desperate to find help for his 71-year-old mother, who had been diagnosed with ALS in December and already had lost the ability to speak. Within weeks, Giostar sent him an invoice for $16,700 to cover three injections of stem cells derived from fat cells, to be administered over a period of months.
The treatments would take place mostly at a clinic in Mexico. The price would include transport between the Mexico clinic and Yuma, Ariz. A down payment of 15%, or $2,505, was required.
Neto ultimately decided not to proceed with the treatment because Giostar “could not give me proof that what they are doing would work.” He said physicians treating his mother at her home in Brazil warned her that there’s “no scientific proof that stem cells work” for ALS.
There is no scientific evidence for the efficacy of stem-cell treatments for diabetes, multiple sclerosis, Alzheimer’s, amyotrophic lateral sclerosis or the other neurological conditions Giostar says it can treat. The only stem cell-related treatment approved by the FDA is the use of umbilical cord blood for some blood diseases.
The FDA has been growing more concerned about medical practices touting purported stem-cell therapies without known scientific validity. In a public notice issued in 2017, the agency stated that “unproven stem-cell therapies can be particularly unsafe,” and has issued formal warnings against some clinics, threatening them with shutdowns. The FDA hasn’t taken any action against Giostar.
Let’s look at what Giostar says about its scientific connections.
But both say they have no connection to Giostar and should never have been listed as board members. Both told me they asked Giostar more than once to remove their names from its website, but both names could still be found on the website in early January. Snyder’s name still appeared as recently as Thursday.
Snyder says he was contacted by Srivastava several years ago and asked for scientific advice for a research project Srivastava was seeking funding for. But the funding never materialized.
“I never had any relationship with them,” he told me. “I think whatever claims they’re making about treatments are wrong, or certainly can’t be validated to my satisfaction.”
He says he didn’t know he was listed as an advisory board member until a colleague mentioned it about a year ago. He immediately asked for his name to be removed.
“Probably, I would be more hurtful to what they want to do than helpful,” Snyder said, “because I’ve not seen data that the cells they’re using are useful for those diseases.”
Carrier, a clinical development executive at FibroGen, a San Francisco biotech firm, says her only contact with Giostar came through a keynote speech she gave at the opening of a hospital in India with which it had some financial involvement. She says she requested that Giostar remove her name from its website “because I was not involved in any of their activities whatsoever. I had no meetings, didn’t know what was going on financially, therapeutically, whatsoever. I didn’t want to be involved in any entity doing clinical trials without FDA approval.”
Patel, the CEO, said in an interview that Snyder’s name remained on the website after he requested its removal because of a technical problem. Srivastava, in the same interview, said he “cannot contradict” what Carrier said about her relationship with the company; her name was removed from the website after I queried Patel and Srivastava. Giostar removed Beutelspacher’s name from its website as of Friday morning, after I asked about it.
Now let’s turn to Srivastava’s credentials, which are the bedrock of Giostar’s assertion of stem-cell treatment leadership. Patel acknowledged in an email that some of Srivastava’s descriptions of his prior academic appointments have been exaggerated. They include his claims on the company website to have been an associate professor in the department of cellular and molecular biology at UCLA’s medical school, an associate professor at UC Irvine medical school, and an assistant professor at UC San Diego medical school.
According to the schools, Srivastava held none of those posts, which almost certainly would have been tenure-track appointments. UCLA says its medical school does not have a department of cellular and molecular biology.
In an email, Patel amended Srivastava’s descriptions, stating that he was a “visiting associate researcher” at UCLA’s department of molecular, cell and developmental biology, which is not part of the medical school; an “associate project scientist,” not an associate professor, at UCSD’s cancer center; and an “associate project scientist,” not associate professor, at UCI Medical School.
Srivastava also claimed to have held an appointment as “visiting senior scientist” at the Burnham Research Institute for Medical Science in La Jolla (now the Sanford Burnham Prebys Medical Discovery Institute). The institute says it offers no such title, but that it has a record of Srivastava’s appointment as a “visiting researcher” from 2009 to 2012; Patel confirmed Burnham’s version.
Srivastava also claimed to have participated in the “first FDA approved human clinical trial” of stem-cell research on spinal cord injury for the “Christopher & Dana Reeve Foundation.” The Reeve Foundation says it did not fund that trial, which was conducted by UCI biologist Hans Keirstead and was approved in 2010, years after Srivastava left Keirstead’s lab. Patel acknowledged that Srivastava’s name should “not be connected with the Reeve Foundation.”
Srivastava also claims to have “directed [the] stem cell core facility” at the Salk Research Institute in La Jolla (actually, the Salk Institute for Biological Studies) and to have served the facility as “senior scientist.” The Salk says neither is true.
Salk records show that he was hired as a researcher for one year starting in February 2008, moved to an unpaid collaborator position in February 2009, and ended his relationship with Salk that March. “Our records do not indicate that he was a Director of the Salk Stem Cell Core or Senior Scientist,” an institute spokesperson told me by email.
Scientists involved in stem-cell research, including on neurological diseases such as ALS, are skeptical of claims of success with treatments similar to those practiced by Giostar.
“Patients are desperate, and there is a big placebo effect” from overhyped therapies, says Clive N. Svendsen, an expert on neurodegenerative diseases who studies potential stem cell therapies for them at Cedars-Sinai.
Trials of stem-cell treatments for ALS are ongoing, including one at Cedars, UCI, and four other locations funded with a $15-million grant from the California stem-cell program.
That trial is in the process of recruiting 200 patients, half of whom will receive a placebo, with a report expected no earlier than 2020. But expectations are that it will show that the treatments can slow the disease progression at best, not produce “improvements” in the patients, as Giostar claims. “Nobody thinks it’s going to reverse the disease and cure ALS,” Svendsen says.
Unsupported promises are rife in the field, aimed especially at patients with diseases that have no known cure, such as ALS. “The term ‘stem cell’ is like snake oil these days,” Svendsen says.