By Katherine Sypher and Anthony Wallace
With the help of his church community, a disabled Valley man finds hope in the form of a cutting-edge – and unproven – stem cell treatment in Mexico. And he’s not alone.
David Latina sits with his wife at golden hour in an upscale Spanish colonial-style plaza in Los Algodones, Mexico.
He is nervous, but hopeful.
It’s a quiet evening in October, and tomorrow the 70-year-old Latina will receive the first of three non-FDA-approved stem cell injections at Baja Surgery Center – a newly built, multipurpose medical facility partly owned by a member of his church back in Phoenix.
Latina’s expectations are modest. He wants only to regain the use of his hands, to be able to use the computer and to brush his teeth without the help of his wife, Aracely. For the past three years, the ex-police officer has done little more than watch TV.
“There are days when I wake up that I feel very empty,” Latina says.
Almost exactly three years earlier, in October 2016, Latina woke to use the restroom, tripped over a decorative faux tree and slammed his head on his nightstand. As his limbs went numb and folded beneath him, he yelled for his wife.
“There was so much blood,” Aracely says.
He hasn’t walked since.
Latina is one of many people who, desperate for healing and disillusioned with traditional health care, are turning to expensive, non-FDA-approved stem cell therapies offered by private, for-profit entities often based outside of the United States. The Latinas’ three visits to Los Algodones will ultimately cost them $20,000 – most of which, they say, was raised through their close-knit church community, via several crowdfunding campaigns.
Generosity, in this case, will cover the bills. Orchestrated by the same church leader who co-owns the clinic, the donations will also help feed a booming cross-border industry with dubious medical bona fides, one that – like countless ventures before it – swiftly and cheaply allows desperate Americans to get the medical treatment they need.
Or think they need.
SHATTERED BODY, NEW FRIENDS
Latina moved to the Valley with Aracely following his retirement from the San Bernardino County California Sheriff’s Department, where he worked for 25 years. The retirement was not by choice. He loved his job.
In 2005, Latina inched his patrol car into an intersection on his way to a routine assignment at a city council meeting. A distracted driver blew through a red light and slammed into him. Latina’s wrist and neck were injured severely enough that the department prohibited him from working again.
Within a month of the injury, his wife at the time was diagnosed with stage 4 stomach cancer. She was dead within a year. “I was extremely depressed,” Latina says. “My wife was gone and my career was gone. I felt like I was getting squeezed in between two buildings.”
In his late 50s at the time, Latina slowly rebuilt his life. He met Aracely and starting making a decent living as a cigar shop attendant. In 2012, the couple married, moving to the North Phoenix community of Anthem not long after. They loved the area’s expansive landscapes and easy access to beautiful getaways, like Sedona and Flagstaff.
When the couple arrived in Anthem, Aracely led a “church-shopping” operation. After a few duds, they landed on Canyon Church of Christ, a nondenominational Christian church housed among insurance offices in a beige strip mall across the street from an In-N-Out Burger off the I-17 and Carefree Highway.
Then came his catastrophic collision with the nightstand. Later, a doctor likened Latina’s body to a glass. The car accident cracked it and the nightstand shattered it.
Latina’s last memory of the night of his accident is being loaded into an ambulance on his driveway. Aracely recalls him screaming in pain on the gurney before the paramedics sedated him.
The days following the accident are a blur. He underwent three major surgeries in rapid succession. At one point, doctors told Aracely he had a “1 percent chance” of survival. But in a matter of weeks, Latina was stable and determinedly moving toward recovery. After a month and a half of intensive speech therapy, he could talk again.
Before the accident, Latina would habitually skip out partway through services at Canyon Church of Christ to catch a shift at the cigar bar. But afterward, everything changed. Suddenly, Latina couldn’t work, and Aracely’s full-time job became caring for him. The bills piled up rapidly. To their relief, the church community rallied around them and provided critical spiritual and financial support. It became the new center of their lives.
“Everyone is so generous,” Latina says. “Still after three years [after the accident], every Sunday, [people come up and ask], ‘How are you, Dave?’ ‘How you feeling?’ ‘How’s your treatments going?’ [They’re] just loving, caring people.”
Churchgoers who saw Latina every week marveled at the slow but steady pace of his rehabilitation. The Latinas credit the “wonderful people” at Encompass Health Rehabilitation Hospital of Scottsdale with helping restore his speech and some of his limb function. Each week, his therapist measured the range of motion in his arms and legs, and each week it would get better.
But in early 2019, they discharged him, insisting they could do no more for him. His hopes for walking again evaporated. “It was like somebody had just slammed my fingers in a door,” Latina says.
He settled into a bleak daily routine of TV and inactivity. The Trinity Broadcasting Network in the mornings and car shows in the afternoons. “It’s hard to wake up with a positive attitude sometimes,” Latina says.
Still, he had Aracely and he had the church. They kept him going. One of the church members who lent their support was a businessman named Jay Carter, who’d earned the distinction of “elder,” a respected figure parishioners can turn to in times of need.
As it happened, Carter – a former Kraft Foods executive and self-identified “serial entrepreneur” from Phoenix – had recently branched into medical technology. And when he heard Latina’s story, he had a hunch he could help.
BEYOND THE ROOT CANAL
Around the same time Latina took his fateful fall in Phoenix, Baja Surgery Center opened in Los Algodones, a town of 5,500 people located in the extreme northeast corner of the state of Baja, just across the border from Yuma. Known primarily for its cheap dental work, Los Algodones boasts more than 600 dental clinics packed into four square blocks. Its nickname is Molar City.
However, thanks to the growing American propensity to travel for treatment and a subsequent influx of foreign investment, Molar City is branching out. Tourists can now get Botox and liposuction, purchase insulin or Viagra – and even receive stem cell treatments, such as the kind Latina would ultimately receive at Baja Surgery Center.
Los Algodones is hardly the only hot spot for medical tourism in Mexico. According to Wise Guy Reports, the worldwide market will more than double between 2018 and 2023, from $56 billion to $136 billion. Patients Beyond Borders, a popular medical tourism guidebook, reported that 1.7 million Americans traveled to another country for medical treatment in 2017.
Carter spotted the trend and wanted in. He and his partner, David Keller, operate a consulting firm called Sage5 Global Consultancy. Both have enjoyed long careers in business, but neither had any experience in the medical field until meeting Dr. Anand Srivastava “around five years ago,” according to Carter.
Srivastava came to Carter and Keller in the hope they could, in Carter’s words, “globalize his business” – the Global Institute of Stem Cell Therapy and Research, or GIOSTAR. Srivastava claimed to have developed a novel, proprietary stem cell treatment method in India, one that offered a radical new way to modify stem cells. Unlike the vast majority of comparable treatments, his method purportedly does not require donor pairs to be matched. Any stem cell will do.
GIOSTAR offers what it calls “the most unique specialized stem cell therapy. One-of-a-kind treatment that provides people all over the world a new way of living.” According to its website, the treatment is effective on a broad range of neurological and autoimmune diseases including ALS, lupus and multiple sclerosis.
But along with his cutting-edge stem cell treatment, Srivastava brought with him vapors of controversy, which eventually coalesced around an article by Los Angeles Times columnist Michael Hiltzik, who disputed many of Srivastava’s claims about his career and background.
The report, published in January 2019, showed the doctor had exaggerated his roles at a number of institutions. For example, Srivastava claimed to have “directed [the] stem cell core facility” at the Salk Institute for Biological Studies in La Jolla. According to a spokesperson at Salk, he held no such role, and was hired only temporarily as a researcher. UCLA, UC Irvine and UC San Diego also disavowed employment claims made by Srivastava.
The article also detailed problems with how GIOSTAR represented its board of directors.
When contacted by Hiltzik, multiple members listed on the site said they were not actually involved with the company.
One supposed board member was Sven C. Beutelspacher, a German professor of ophthalmology at University Eye Hospital in Heidelberg, Germany. Beutelspacher told the Los Angeles Times, “I have no relationship with this company. I have never been contacted by GIOSTAR, and it seems they just took my name and placed it on their web page.”
Since the report was published, at least three names have been removed from the board listings on the GIOSTAR website. In addition to Beutelspacher, the site eliminated the names of a pair of respected American stem cell researchers: Ewa Carrier and Evan Snyder.
When asked about GIOSTAR, Carrier – the executive director of clinical development at the San Francisco biotech company FibroGen – told the Times, “I was not involved in any of their activities whatsoever. I had no meetings, didn’t know what was going on financially, therapeutically, whatsoever.”
Carter called into question some of the claims made in the article, referring to a YouTube video showing Carrier on stage with Srivastava and Indian prime minister Narendra Modi. He also points out that the article makes no reference to Srivastava’s science and the efficacy of the medical treatment – the most essential element of GIOSTAR’s operations.
“That’s old news,” Carter says of the article. “We’re trying to help people with diseases. And we’re not going to battle some journalist who didn’t do his research entirely.”
Additionally, according to GIOSTAR CEO Deven Patel, Srivastava’s résumé was toned down, and made accurate. For example, his role with UCSD’s cancer center was amended from associate professor to “associate project scientist.”
The changes, however, are not reflected in all of GIOSTAR’s marketing materials. In an email to PHOENIX reporters, Carter sent the fraudulently exaggerated version of Srivastava’s résumé. And if one accesses the board member list from certain URLs, Snyder and Carrier’s names remain.
The imbroglio has evidently not been bad for business. So far, Carter says, the Baja Surgery Center – one of two GIOSTAR properties in Mexico – has been a lucrative venture. “Medical tourism in the United States has been growing exponentially. It’s amazing,” Carter says. “We’ve been extremely profitable in Mexico.”
Having met Latina back at Canyon Church of Christ, Carter asked the paralyzed man to send him his medical records, which he forwarded to Srivastava. The doctor called Latina at his most dejected and restored his hope.
Srivastava told Latina that he’d looked through his records and determined he was a prime candidate for his special brand of stem cell treatment. Their hope for a full recovery restored, the Latinas launched their crowdfunding campaign. Supported largely by the parishioners at Canyon Church of Christ, they amassed enough money to book the first of three procedures.
Leading up to the procedure, seated outside Baja Surgery Center, Latina is ready to go. He says he has more apprehension about the country’s reputed violence than the delicate surgical procedures to come.
Inside, Latina’s doctor asks him, “Are you ready for a second chance at life?”
“Let’s do this,” he replies.
First, Latina receives an IV of saline solution on a hospital bed in the staging/recovery area. Then he’s wheeled into an operating room, where two doctors begin the procedure. He feels one of them gently probing the vertebrae of his lower back.
“It was just two shots,” he recalls later. “Boom, boom.”
The first shot goes into Latina’s lower spine; the second, into his veins. In the end, he says the injections took “less than a minute.”
Stem cells are unique in the body because they have the potential to develop into a range of other cells. Like an ace in blackjack, which can function either as a one or 11 depending on the player’s needs, a stem cell can adapt itself to the body’s needs.
In adults, these “wild card” cells are already somewhat specialized – their ability to become a new type of cell is limited by their location. For example, stem cells in an adult’s brain can only become cells that reside in the brain, like neurons.
In Latina’s case, the doctors maintain that the injected stem cells, collected from a donor’s fat tissue, will defy this traditionally accepted limitation and become something entirely different. Thanks to Srivastava’s innovations, they’ll theoretically transform into nerve cells and repair Latina’s damaged spinal cord.
The type of stem cell treatment Latina is receiving is not approved by the U.S. Food and Drug Administration – the only treatment currently approved by the FDA involves blood-forming stem cells from umbilical cord blood. However, the FDA has approved clinical trials of stem cell treatment for spinal cord injuries. But none currently listed on the U.S. National Library of Medicine’s clinical trial database utilizes unmatched donor cells, and all offer patients a highly controlled environment to receive experimental care.
Despite the unusual nature of his treatment, Latina says it “never crossed [his] mind” that there would be a problem.
“I felt that the treatment was above board and honest,” Latina says, a few months after the fact.
After his injections, the facility’s doctors wheel Latina to another room, where they place him on a saline drip, fit him with an oxygen mask and give him a vitamin shot. The next morning, he repeats the routine, sans stem cells – drip, oxygen mask, vitamin shot – then makes the three-hour drive back north to Anthem with Aracely.
He plans to make the trip two more times in the coming months.
Carter says Srivastava’s experience and
proprietary technology set Baja Surgery Center apart from other entities offering stem cell therapy. Srivastava’s cells are, according to Carter, safe, “pure” and processed in a way that can’t be replicated. Unlike other stem cell treatment providers, he says BSC patients “have never had an issue with tumors or infections.”
Uniquely, BSC patients are given the choice of taking stem cells from their own fat, or that of a donor. Latina chose to receive his stem cells from a donor. This differs from most patients receiving similar treatments, who have their own cells reinjected.
Receiving cells from a donor is relatively common for traditional stem cell treatments, like bone marrow transplants. Scientists say these transplants are standard practice and accepted as an effective form of care, especially for patients with life-threatening blood cancers. For these types of procedures, as with any transplant, precautions are taken to ensure that patient and donor are compatible.
Not at GIOSTAR. Carter says they have pioneered a new approach, which allows them to skip this step. “It used to be several years ago that you tried, like blood type, to match cells,” Carter says. “But that’s not needed anymore, because we have the ability to reduce that cell down to whatever we need it to be.”
Carter says that by “spinning and cleaning and multiplying” the cells in a Los Algodones laboratory, GIOSTAR modifies them so they are universally compatible with any patient.
According to Carter, the stem cells can be directed to whatever area of the body needs them most – first, via a direct injection to the relevant part of the body, and second, via an intravenous injection.
Regardless of whether the cells originate from a donor or their own body, GIOSTAR tells patients that once the cells are injected, they will know where to go and what to do.
According to stem cell experts interviewed for this story, this is highly unlikely.
Stem cell treatments may have the potential to treat a vast number of diseases and conditions – however, scientists aren’t sure how or when yet. Stem cell treatments like the one Latina received are often associated with grand claims and sweeping promises about their therapeutic benefits.
And unproven stem cell treatments are not confined to Mexico. Clinics offering non-FDA-approved therapies also operate across the United States. Industry experts say these American clinics are allowed to operate only because the FDA has failed to adequately target them. Mexican operations are free from the FDA’s influence entirely. According to those familiar with the industry, patients may turn to these treatments after others have failed them, or doctors have told them little else can be done. But researchers say the science behind stem cell treatment is still too new to know whether these unapproved interventions are safe or effective.
Leigh Turner, a bioethicist at the University of Minnesota who specializes in stem cells, says some clinics will promote their stem cell treatments as a “panacea for everything under the sun,” for ailments ranging from arthritis to Parkinson’s disease to erectile dysfunction and more. He called GIOSTAR’s practice of not matching the cells from donors and patients “particularly weird and wacky.” Additionally, Turner says the process could cause serious harm by increasing a person’s risk of a negative immunological reaction or of contracting an infectious disease.
According to Bruce Bunnell, director of the Tulane Center for Stem Cell Research and Regenerative Medicine at Tulane University, there is no standard method of stem cell treatment, and patient reactions can vary widely. “It’s a very mixed bag of outcomes,” Bunnell says.
On the afternoon before Latina’s first treatment, employees at the Baja Surgery Center privately commented on the efficacy of the treatment. “We have seen people get better, but we have actually seen also people… well, their condition gets worse,” a BSC nutritionist said. “It’s not miracles.”
Bunnell says that uncertainty, however, is not always well-communicated to patients. “Many of these patients, they’re desperate for anything,” Bunnell says. “These families are desperate.”
According to Emma Frow, an assistant professor at Arizona State University’s School of Biological and Health Systems Engineering, this desperation may drive patients to unproven interventions. “If you’ve been told by your doctor that there’s really nothing else they can do for your arthritis and you’re just gonna have to learn to live with it, I can completely understand why somebody might want to consider stem cell treatments,” Frow says.
Researchers say it can be difficult to determine which clinics offer patients legitimate services and which do not. “Not all clinics are the same,” Frow says. “As a patient, you take on an awful lot of the burden of having to sift through this space.”
In the course of his research, Turner says he has seen stem cell clinics advertise “problematic misrepresentations” of what the treatments can offer patients.
Clinics feature personal testimonials from former patients, exalting the therapy as the treatment that improved their well-being after others failed. GIOSTAR Mexico’s YouTube page features more than a dozen such testimonials. On its website, GIOSTAR says it is revolutionizing medical treatment with “a cure for human diseases with innovative stem cell-based therapies.”
Still, Turner says it would be wrong to characterize the people who patronize these clinics as uneducated or uninformed. “I think actually any one of us could be in the shoes of these individuals,” he says. “These businesses are built to convince people.”
Turner says the burden of proof should be on the provider, not the patient. In reference to GIOSTAR’s unusual, no-match donor process, he says, “If they say that they have some sort of stem cell secret sauce and they’re not sharing it, I think the burden is on them to make the case that their claims are true.”
According to Bunnell, some clinics do offer legitimate services, such as those offering stem cell treatments as part of an FDA-approved clinical trial, but he is unconvinced this is true of every provider. “I think there are also a fair number of unscrupulous providers who are offering people false hope and providing them unknown treatments for diseases where, if they are even using stem cells, there’s no hope of the stem cells actually curing the disease that they’re promising people cures for,” he says.
Carter says GIOSTAR does not guarantee cures. “There’s a lot of factors that enter into this,” he says. “It’s still a study in process. We’ve helped a tremendous amount of people. Some we helped more than others.”
As evidence for the treatment’s efficacy, Carter talks about a time when Srivastava treated his business partner, David Keller, for chronic nerve damage in his eye. During a trip to India, Srivastava injected him with his own stem cells. “The next morning he woke up with no pain in his right eye,” Carter says.
Visualizing Stem Cell Transplants
Currently, the most common stem cell procedure involves harvesting stem cells to replenish red-blood-cell-producing bone marrow damaged during chemotherapy of lymphoma and leukemia patients.
1. Stem Cell “Mobilization”
Drugs are administered that inspire the patient’s body to produce stem cells that move into the bloodstream.
2. Stem Cell Roundup
The patient’s stem cells are collected from their blood and/or bone marrow, a technique known as autologous extraction.
3. Machine Processing
The blood is run through a machine that culls the stem cells, which are then frozen.
4. Killing the Cancer
Chemotherapy is applied to the patient to kill the remaining cancer cells. In the proess, bloodproducing cells in the bone marrow are also destroyed.
5. Reinfusion of Cells
The patient’s frozen stem cells are thawed and returned to the body, where they restore the bone marrow’s cell-producing capacity.
Source: Leukemia & Lymphoma Society
TELLING A STORY
On a late Sunday morning in mid-November, members of the Canyon Church of Christ find their seats. It’s a low-key gathering – about 60 people are present, although the room would fit more than double that number. Cut vinyl letters adhered to the wall beside the altar read, “Loving God, Connecting People, Unleashing Compassion.”
On this day, about three weeks after his first treatment in Mexico, Latina is set to deliver a speech to the congregation. About halfway through the ceremony, he steers his motorized chair up the ramp and takes his place center stage. For most of the talk, the former sheriff and cigar bar sales clerk is collected and confident. But when he begins to speak about what the church has meant to him and Aracely, he gets choked up.
Following the speech, senior minister Daniel Hayes takes the podium. He praises Latina’s faith and thanks him for “representing the kingdom.”
According to Latina, his treatment wouldn’t have been possible without the financial support of his church community and their crowdfunding campaigns.
Due to the high cost of the treatment, Turner says there is a misconception that wealthier people are paying out of pocket for stem cell treatments. But his research has shown the opposite is true; many non-wealthy patients rely on crowdfunding to cover the high treatment costs.
Sites like GoFundMe and CrowdRise allow treatment seekers to raise money by gathering large numbers of small donations from friends and family. With the help of Carter, Latina set up a GoFundMe campaign to raise money for his own treatment. The key, Carter says he told Latina, is to tell people your story.
On Latina’s page is an 18-minute video in which he lies in bed beside Aracely as they tearfully discuss his accident, their faith in God and their hopes for a better future.
Carter says he encourages crowdfunding for prospective Baja Surgery Center patients who could otherwise not afford the treatment. “I am 100 percent for it, because I think it gives people an opportunity to participate in what you’re going through,” Carter says. “And what we see is that people are looking for worthy causes to give to. And this was certainly one of them.”
According to Turner, crowdfund pages for unproven stem cell treatments spread misinformation about the efficacy of the treatments and waste money. They are particularly effective, he says, when they target tightly knit social networks – like church communities.
“Part of the marketing activity, part of the act of recruiting individuals… takes place in social networks where trust already exists,” Turner says. “And that trust is taken advantage of and mobilized.”
At the conclusion of the service, Latina positions himself near the exit, where a litany of fellow parishioners meet him on their way out. Aracely looks on from afar as person after person approaches Latina, offering hugs, handshakes and concern as he answers their questions about his life and treatment. As she waits for the procession to relent, Aracely jokes that her husband is famous. On this day, she coins a new nickname for him: “Ringo Starr.”
Like the rest of the church community, Carter hopes Latina’s stem cell therapy works. “There’s no better feeling than to know you helped somebody regain a quality of life that they lost. I don’t think there’s a better business to be in,” Carter says. “Our prayers would be that David will be dancing again one day.”
Once the church is empty, Aracely helps Latina into their customized Mercedes sprinter van, another prohibitive cost the church helped with. They’re going to a regular spot: William’s Coffee Co. It’s hard to leave the house, and since they’ve already gotten out for church, they figure they’ll extend the excursion.
The following December, Latina reports he hasn’t noticed any improvements in his condition yet, but still trusts the information given him by GIOSTAR: Every patient reacts differently to treatment, and progress could take time. He remains optimistic. “They said, ‘You’re definitely, definitely, definitely going to get positive outcomes – something,’” Latina says.
Fast-forward to March. As the coronavirus pandemic erupts around the country, the Latinas have just returned from Latina’s third and final stem cell injection. He’s also returned to physical therapy, though he stopped attending as the pandemic worsened. Aracely says that although her husband gained a little movement in his arms and legs, they haven’t seen “much of a difference.”
Despite the disappointing results, Aracely says she would recommend the treatment to others. She says the treatment “just makes sense” and feels Latina’s older age and severe condition going in made his case less successful. There has been one noticeable difference in Latina’s condition, however.
“He can kick me,” Aracely says with a laugh.