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Patients Turn To San Diego Stem Cell Companies For Costly, Unproven Treatments

Editor’s note: To read part two in this two-part series, click here

Part. I. Jim Gass contacted San Diego-based Stemedica with the hope of recovering from a debilitating stroke. After following its referral to a Tijuana doctor, he got worse.

Jim Gass made sure to record the moment in an iPhone video because he’d paid tens of thousands of dollars and traveled a great distance to get there.

In the video, Gass can be seen sitting in his wheelchair in a beige hospital room. He smiles while a doctor injects something into his arm. In case there’s any question about what’s going into Gass’s vein, the doctor points to the syringe and says, “Stem cells.”

Translating into Spanish a moment later, he says, “Células madre.”

Gass traveled to Hospital Angeles in Tijuana, Mexico with the hope of recovering from a debilitating stroke. He received stem cells from Dr. Cesar Amescua based on a referral from Stemedica Cell Technologies, Inc., a San Diego company known for reportedly helping famous former athletes like hockey legend Gordie Howe make “miraculous” recoveries from strokes.

But Gass didn’t get better.

What he didn’t know, smiling in that iPhone video, was that his paralysis would get worse. Nor did he realize that his doctors back home would later find what they call a bizarre tumor in his spine, where Gass says he received injections of fetal stem cells procured by a different company, Global Stem Cell Health, Inc.

An excerpt from KPBS' interview with Stemedica spokesman Dave McGuigan

Gass had found himself caught up in the world of “stem cell tourism.” The stem cell treatment industry is flourishing in the U.S. without much oversight. Southern California is a hotspot for clinics advertising stem cell treatments for everything from stroke to autism. And experts say San Diego is an attractive location for any company hoping to usher patients across the border for expensive treatments that have not been proven to be safe or effective in humans.

The U.S. Food and Drug Administration held a meeting on stem cells this month, possibly signaling moves toward increased regulation. Some scientists think regulators are not doing enough to oversee a growing industry they believe preys on desperate patients. UC San Diego stem cell researcher Larry Goldstein said his field would welcome regulation to protect consumers from what he called “snake oil treatments.”

“Thoughtful FDA regulation of the growing stem cell industry is essential to help consumers distinguish fraudulent claims from legitimate clinical trials, research and therapy development,” Goldstein wrote in an email.

Stemedica spokesman Dave McGuigan defends the company’s practices in the U.S. and beyond, saying, “Through our clinical trials in the United States and outside the United States, well over 500 patients have been treated since 2009. And we haven’t had a serious adverse event.”

When asked for comment on Jim Gass’ treatment in Tijuana, McGuigan initially said that Gass had never been treated with Stemedica cells. McGuigan also insisted that Stemedica never referred Gass to Dr. Amescua. Shortly after KPBS showed him emails and footage contradicting his assertion, McGuigan — still on camera and wearing a KPBS microphone — told a fellow Stemedica employee, “Clearly what we’ve been saying as a statement of fact has been incorrect.”

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Jim Gass's email correspondence with Stemedica

Jim Gass's email correspondence with Stemedica

Stemedica's Marcie Frank corresponded with Jim Gass via email in late 2013.

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The day after the interview, Stemedica officials confirmed that their company did refer Gass to Dr. Amescua, and that Gass was in fact treated intravenously with Stemedica’s adult stem cells. Those were distinct from the fetal stem cells Gass says were injected into spine.

McGuigan said Stemedica works hard to advance stem cell research in a scientifically sound and legally compliant way. But Stemedica has faced criticism over the work it’s associated with outside the U.S.

A former member of Stemedica’s scientific advisory board is among those questioning some of the company’s practices. Mahendra Rao, currently the vice president for regenerative medicine at the New York Stem Cell Foundation, wrote in an email to KPBS, “Their work with athletes, their interaction with poorly monitored clinics and their business strategy leave me uncomfortable.”

"He was my hero"

Gass spent most of his life in Boston, but for the moment he lives in San Diego County. On most weekday mornings he can be found exercising at Project Walk in Carlsbad. Project Walk is sort of like a gym, but for people dealing with varying degrees of paralysis. Here, a personal trainer helps Jim get out of his wheelchair and put his languishing muscles to work.

“My goal is to transfer from this chair to a bed without using a lift,” Gass said. “And right now I can’t do that.”

Gass had a stroke in 2009 at the age of 60. He lost the use of his left arm and leg. Walking was still possible with the help of a cane and a leg brace. But his career as an attorney, his active lifestyle, his love of traveling the world — all of that came to a halt.

Photo caption: Jim Gass is pictured at a Project Walk's paralysis recovery center in Carlsba...

Photo by Kris Arciaga

Jim Gass is pictured at a Project Walk's paralysis recovery center in Carlsbad, July 20, 2016.

Gass said his doctors told him there was no cure for his paralysis, and he should focus on physical therapy. He couldn’t accept that there wasn’t anything else he could do.

“I got interested in treatment,” he said. “It turned out that stem cells appeared to be what everybody was focused on as the treatment of the future for stroke.”

Scientists in the field of regenerative medicine say stem cell treatments are on the horizon for a number of conditions, but they’re still in early stages and it’ll be years before they’re approved.

Nevertheless, online searches yield plenty of inspiring stories about stroke patients who’ve gone abroad for stem cell treatments. Gass knew these treatments hadn’t been proven to work, but he decided he was willing to pay expensive fees and travel across the globe on the chance they might help him regain some control of his body.

Gass traveled to China and Argentina for a series of stem cell treatments in 2011. He said those treatments didn’t seem to help, but they didn’t seem to hurt. So he decided to give stem cells another shot, based partly on what he’d been hearing about retired NFL star John Brodie.

“He used to be the quarterback for the San Francisco 49ers,” Gass said. “When I was growing up, he was my hero.”

Brodie, another stroke victim, was said to be making a dramatic recovery thanks to stem cells. In late 2013, Gass emailed the company linked with Brodie’s treatments. That company was Stemedica. In an interview with MoneyTV from 2010, Stemedica chief executive officer Maynard Howe discussed Brodie’s treatment.

Photo credit: Courtesy of Jim Gass

Cesar Amescua administers an injection into Jim Gass in 2014.

“John was part of a clinical study that was conducted outside of the United States,” Howe said. “John had a miraculous recovery. He’s back playing golf now. He’s got his speech back. And John travels all over the world by himself.”

A few years after Brodie’s treatment, another former athlete and stroke victim was reportedly walking again following treatment in Tijuana with Stemedica’s cells. This time it was hockey legend Gordie Howe (no relation to Stemedica executives Maynard and Roger Howe). Howe, who died earlier this year, reportedly received Stemedica’s cells free of charge in Tijuana from Dr. Amescua, the same doctor who would treat Gass.

In a San Diego TV news story about Howe’s recovery, Dr. Amescua is shown saying, “We cannot claim that we will cure the patient with stem cells. OK? But we can definitely say that patients will have an improvement.”

Stemedica continues to make news with another former NFL athlete’s story of recovery. In a USA Today article published earlier this month, former Green Bay Packers quarterback Bart Starr discussed his repeated trips to Tijuana for treatments with Stemedica cells.

Stem cell scientists don’t discount the possibility that these men saw their condition improve. But they say beyond anecdotal evidence, no proof has been offered that stem cells were responsible for anyone’s “miraculous” recovery.

Stemedica has used variations on the word “miracle” in connection with stem cells on a number of occasions. Stemedica executives have even co-written a book titled “The Miracle of Stem Cells.” The company’s website includes a link to purchase the book for $39.95.

Spokesman Dave McGuigan said patients are clearly informed that Stemedica cells come with no promises. “We absolutely do not promise to cure patients,” he said.

"We have had NO cases of infection or adverse events"

Gass, however, was sold.

He emailed Stemedica to ask where he could go for treatment. A company representative referred Gass to Dr. Amescua, a man Stemedica has described in the past as its “Medical and Regulatory Affairs Director for Latin America” (the company said it has no relationship with Dr. Amescua today).

The Stemedica representative wrote to Gass in an email, “Hospital Angeles in Tijuana, Mexico is approved by the Mexican FDA equivalent (COFEPRIS) to conduct a stroke trial with Stemedica's stem cells.”

Gass said he followed Stemedica’s referral and got in touch with Dr. Amescua. He said further down the line, he was told that for $30,000, he could receive a round of treatment involving two different types of stem cells.

The first type, Gass said he was told, would be mesenchymal stem cells. He said he was informed that they would be manufactured by Stemedica, and would be injected into a vein in his arm. Stemedica said its mesenchymal stem cells are derived from adult bone marrow.

Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).

Also based in San Diego County, GSCH is run by Dr. Michael Bayer, a former Stemedica executive. Stemedica spokesman Dave McGuigan said there’s now “a clear separation of church and state between what Michael does and what Stemedica does.”

Photo by Kris Arciaga

Stemedica spokesman Dave McGuigan is pictured in the company's San Diego office, Sept. 7, 2016.

A GSCH representative explained the distinction to Gass in an email, writing, “Stemedica cannot treat patients because of FDA regulations, and this is how GSCH was started — to treat ‘no option’ patients seeking alternative therapies.”

Gass said he went to Tijuana twice for two separate rounds of treatment in 2014, and his bank statements show that he wired $30,000 to GSCH on two separate occasions that year.

Stem cell experts say that mesenchymal cells such as those produced by Stemedica cannot replace destroyed neurons, the very cells killed during a stroke. Limited evidence has shown possible benefit from injecting modified mesenchymal stem cells directly into the brains of stroke patients, but Gass received Stemedica’s mesenchymal cells intravenously.

The use of fetal stem cells in Gass’ case was also highly suspect, according to scientists in the field. They say patients receiving fetal stem cell treatments in other countries can’t always know for sure where these cells come from or how they’ve been prepared for injection. No definitive evidence has been published showing that fetal stem cells can help people recover from a stroke.

Stem cell scientists also warn that tumor formation is a distinct possibility when introducing fetal stem cells into humans without proper precautions. A GSCH representative wrote in an email to Gass, “We have had NO cases of infection or adverse events.”

Gass said after each of his treatments in Tijuana, he was told to wait three to six months for signs of improvement. He said after the second treatment, something happened.

"I started to feel changes,” Gass said. “But they were not good changes. I started to feel pain in my back."

"There’s really nothing like it in the textbooks"

At this point, Gass said he was also starting to lose even more feeling and movement below his waist. When his doctors in Boston discovered what was causing his back pain and worsening his paralysis, they were shocked.

“None of us had ever seen anything like it,” said Dr. Aaron Berkowitz of Brigham and Women’s Hospital.

Berkowitz and his colleagues found a growth developing in the lower part of Gass’ spine, where Gass said he received injections of GSCH’s fetal stem cells in Tijuana. Genetic analysis revealed that the growth was partly made up of cells from another human being.

Berkowitz said even putting a name to this growth was challenging. It was growing like a cancer, but it didn’t have the genetic signatures of cancer.

He said, “There’s really nothing like it in the textbooks.” But, he said, “Literally, it’s a tumor, in the sense that it’s an abnormal swelling.”

Earlier this year, Berkowtiz co-authored a paper in the New England Journal of Medicine about Gass’ situation.

“We could point very tangibly to a very important risk that patients should be aware of before pursuing something like this,” Berkowitz said.

Gass gave his doctors the go-ahead to fight the tumor with radiation, and that seemed to halt the swelling. But Gass is concerned it may be growing again. He doesn’t rule out the possibility that he could one day sue those connected with his treatments.

Gass isn’t the only patient who has experienced complications after receiving stem cell treatments. Medical journals have documented two similar cases. One patient was found to have masses in one of her kidneys following a stem cell treatment. In another case, a brain tumor was discovered after a boy suffering from a rare neurodegenerative disease received injections of fetal stem cells. Both journal articles kept the patients anonymous.

Gass received stem cell treatments in other countries years before going to Tijuana. Berkowitz said without a sample of the cells used in each case, he can’t be certain which treatment is directly linked with the tumor. But Berkowitz said Gass only reported feeling pain in his back after the second round of treatment in Tijuana, which Gass said included injections of GSCH’s fetal stem cells into his spine.

"We have no current plans to publish our results"

Jeanne Loring, a scientist at the Scripps Research Institute in La Jolla developing a stem cell therapy for Parkinson’s disease, spoke with KPBS about the stem cell treatment industry broadly, not about any company in particular, because some firms have a reputation for being litigious.

“It’s unfortunate that what I work on and what they work on are both called stem cells, because they’re not at all the same,” Loring said. “It’s not a terrific idea to be putting stuff that you don’t know very much about into people and expecting it to work.”

Companies promoting stem cell treatments often say they’re only facilitating research. They say they don’t promise to cure patients, only to connect them with clinical trials.

Stemedica is sponsoring a number of clinical trials overseen by scientists at reputable institutions within the U.S. These trials are listed on ClinicalTrials.gov, an online database of human medical studies maintained by the National Institutes of Health.

Photo by Kris Arciaga

Stem cell scientist Jeanne Loring is pictured in her office at the Scripps Research Institute, July 20, 2016.

One ongoing Stemedica-sponsored trial approved by UC San Diego’s Institutional Review Board is primarily aiming to test whether or not it’s safe to give Stemedica’s mesenchymal stem cells intravenously to stroke patients. Stemedica says it has received the FDA’s approval to move forward with this trial.

The trial started over five years ago, and has not yet reported results. Principal investigator and UCSD School of Medicine professor Michael Levy said the study is proceeding with appropriate caution.

“This is work that needs to be done,” he said. “Because people are paying huge amounts of money to get something that they’re not sure what they’re getting, and to pursue a hope that may not be there. We need to go back to square one where you do the appropriate research and find out if there’s anything factual to support any of this stuff.”

Loring said if a stem cell company truly is helping patients make remarkable recoveries, they should prove it by publishing their results.

“If they had really good results, they would publish them,” she said. “Because that would be like the best marketing strategy.”

Stemedica could not provide published data from any of its human trials.

Gass’ sister-in-law, concerned about the treatment Jim was about to receive, asked Global Stem Cell Health if they’d ever published evidence that their treatments work. A representative replied to her via email, “We have no current plans to publish our results.”

Ethical concerns have been raised about the fees patients are charged to participate in certain stem cell trials outside the country. Loring said patients are not typically charged large sums of money to participate in clinical trials. She thinks patients should be wary of any trial, or any company, that does charge tens of thousands of dollars for participation in a medical study.

When Stemedica spokesman Dave McGuigan was asked about patients who pay large sums of money to receive Stemedica cells as part of a trial outside the U.S., he said Stemedica and their foreign clinical trial partners put up “significant dollars” to carry out these studies, and patients are “asked to participate in those costs.”

“We’re talking about people that have a medical condition for which there is often no cure,” McGuigan said. “And so they have searched the world to find out what their options are.”

Dr. Amescua has confirmed that after KPBS approached him for comment on Gass’ treatment, he was able to find hospital records pertaining to Gass. Global Stem Cell Health did not respond to KPBS’ interview request.

A call for regulation

Gass went through a process often referred to as “stem cell tourism” to receive his treatments. In years past, patients often had to leave the country to seek unproven stem cell treatments. But UC Davis stem cell scientist Paul Knoepfler says that’s no longer the case.

Knoepfler recently co-authored a study identifying 351 stem cell companies advertising unapproved treatments at 570 unique clinic locations right here in the U.S. for everything from autism to Alzheimer’s, stroke to diabetes.

“This kind of turns the idea of stem cell tourism on its head,” Knoepfler said. Now, he said, “Most Americans really don’t have to travel, say, to Mexico or Asia or somewhere in the Caribbean to get an unapproved stem cell treatment.”

Some scientists wonder why the FDA hasn’t taken more action against companies promoting unproven stem cell treatments. Scripps Research Institute scientist Jeanne Loring believes regulators may simply be outmatched.

“The clinics are popping up faster than the FDA can close them,” she said.

An FDA spokeswoman did not comment on Jim Gass’ situation or the specific companies involved with his treatment. The FDA has approved the use of blood forming stem cells in patients with certain blood disorders, but the FDA spokeswoman wrote in an email to KPBS, “At this time, the value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits.”

Loring attended the FDA’s meeting on stem cells earlier this month and spoke about why she thinks better regulation is needed. She believes there could be more patients out there who aren’t coming forward to discuss the harms they’ve suffered in connection with unproven stem cell treatments.

Patients sometimes raise money for these treatments through web sites like GoFundMe.com. Some say they’re willing to take a chance on unproven stem cell therapies because they have nothing to lose.

Gass now knows he did have a lot to lose. He said all told, he lost hundreds of thousands of dollars pursuing stem cell treatments around the world, and now he’s left with a painful tumor and significantly decreased mobility.

Gass hopes other patients considering reaching out to companies promoting unproven stem cell treatments will be more educated about the risks than he was.

He said, “Don’t do it. Look at me. You don’t want to spend the rest of your life in a wheelchair. I don’t either."

inewsource reporter Leo Castaneda contributed to this report.

Part two of this series will be published Wednesday.

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