EFTA Document EFTA01735661

DNESDAY. SEPTEMBER 2.2015 USA TODAY SPORTS. THE NATION'S NEWS a 0 s. USA TOGA TM 0 9. 0 2 .1 if A GANNETT COMPANY `Soup' therapy promises healing strouroas. motor scan --Clbsieespealala let Lisa Santia- go works in Florida for Joseph Perils, who has a his- taaee otfhelping heal with stem cell treatments. Treatment touted as surgery alternative - amid effectivenessand legal concerns Brent fichrotenbocr (aSchrotenhier USA TODAY Spans Pbr a minimum price of $15,000, several professional ath- letes recently received a curious new medical treatment ha New York. It's called "The Soup" — &mix- ture of human cells that includes stem cells derived from a pa- dent's own fat If It works the way thy-holm The Soup mai* re- pair injuries that otherwise might require surgery — damaged • knees, elbows, hips, necks and more. "Traditional medicine and STEM CELLS traditional AND SPORTS =for d: lotnootf patients," said Steven Victor, founder and chair- man of The Soup's manufacturer, IntelitCell ftioSciences "This kind of cellular therapy can really be a savior to them!' It's an exploding field. Just a ► STOltV CONTINUES ON EFTA01735661 6C SPORTS SUM CELLS Ally SPORTS USA 'FORM WEDNESDAY, SEPTEMBER 2.201° Combo of cells potential alternative to surgery COMMUMMOIS few years old, IntelliCell's tech- nology already has served various active and former pro athletes, including Merril Hoge, a former NFL player who says he was blown away by how quickly his el- bow injury healed after being treated last year. James Andrews, the most prominent sports doc- tor in America. even agreed to serve as a consultant to the com- pany and was issued 18 wdthon shares in company stock as com- pensation, according to recent government filings. But here's the catch: Nobody knows if this type of treatment really works or If it's even legal under U.S. Food and Drug Ad- ministration (FDA) rules, accord- ing to ollertssonsullabrila TODAY Sports. The same can be said about a rapidly increasing number of American clinics that have been offering stem cell ther- apies to help a wide variety of health concerns, ranging from ar- thritis to Ahheimer's disease. Stern cell clinics in the USA have quadrupled in the last live years to nearly 200, according to an estimate by Paul Knoepfler, a stem cell expert at the Univenity of California-Davis. 'It really does feel like a big ex- periment, and people are paying • lot of money to be part of tide Knt rsaid The sports clientele is a driving factor, along with Baby Boomers looking for alternatives to sur- ge-Us— MO watt WA TOOK, VON Steven Victor. founder of intellifell BioScience, . c.t..idipom. i-sue fr a patient at tteGen Medical in New York. EFTA_R1_00019792 EFTA01735662 `As the number of professional athletes getting stem cell treat- ments continua to climb ... I think the number of ordinary people is likely going to continue to climb, too? Knoepfler said. Such growth is a concern, ex- pert say, because the market for these clinics appears to have rocketed beyond the boundaries of government regulation and es- tablished science. Take IntelliCell, for example. The company's recent history shows the risks of operating in this vast new medical frontier, where the law has been vague and treatments haven't been scientifi- cally proved. In March 2012, the FDA Issued a warning to Victor, saying Intel- liCell's product violated the law and should be considered a new drug — a designation that would require long and expensive clini- cal trials to determine whether it's safe and affective for public occaumption. Former IntelliCell employees also recently filed two federal lawsuits against the company, ac- cusing Victor of making false statements about his product and manipulating data to boost its prospects — accusations he says are bogus. to paling their careen. Purita declined to name the NFL player who received treat- ment in July. Many of them have wanted to keep such treatments secret, largely because team man- agement might disapprove of such alternative medicine. -This can affect their contract negotiations and all kinds of things, and so some guys come without the team even knowing," Purita said. 'They don't want the team to know, so we Just kind of keep it quiet? Victor says his sports clients also didn't want to be named but adds that teams have become more accepting of this treatment in recent years. IntelliCell's list of medical advisers includes doctors for the Oakland Raiders, New York Rangers and Andrews, who had planned to use the IntelliCell product at a lab in Florida An- drews didn't return several mes- sages seeking a comment. He and others have said they think cellular therapy is the cut- ting edge of sports medicine, a way to avoid surgery and heal faster more naturally. Hoge, the former running back, says a liga- ment in his right elbow was 60% torn but healed in six weeks after receiving stromal --bfeanwitliedireartelal-problems—vascularfeaction have increased Last year, Intent- tific name of The Souµ Cell — which is publicly traded — After fat tissue was extracted from his side in New York, sound waves were used to separate the cells from the fat The cells were injected into his elbow in a bid to help it regenerate and heal. 'Stem cell therapy is your body healing yourself; Hoge said. 'For me, it worked out beautifully, and I avoided a Emery. I avoided six-month rehab process. I was completely better in six weeks versus six months? reported an accumulated deficit of $64 million. Yet Victor Isn't backing down. Unlike other cellular therapy clinics, Victor says his company is doing things the right way, ac- cording to the law, because his lab is registered with the FDA. ;If you look et other (stem aril clinics), they're kind of winging it," said Victor, a cosmetic derma- tologist and self-described mad scientist. "They don't really fol- Iowa fpAsits.'L „MALI But beanie it's such a new and Yet quations pant out this rapidly evolving field. it's hard to and similar treatments because tell who's right, what works and they have not undergone enough what doesn't. rigorous testing to determine their safety and effectiveness. trCA 9 1.4 4 04- i Z. ,t .4- 4 4 '4' • •t Ix, outside the country — in Bogota, Colombia. 'The FDA made me sign an agreement that I wouldn't do that anymore in the United States" Williams said. He says the FDA had an issue with him using fat-derived cells for these purposes. "We were doing the same thing everybody else was doing, I think? Williams said, referring to similar clinics using fat-derived stem cells. "It's just that we be- came kind of known a little more quickly than some of these other at" The FDA declined to comment on the case, leaving questions un- answered about how this clinic was manipulating stem cells dif- ferently than other US clinics that offer similar fat-derived stem cell treatments. I CANT DIPINIMILY SAY' McClain isn't the only athlete who can't say for certain if the an -fee- tors helped instead. Former pitcher CJ. Nitkowsld says he paid about 112200 to get an injection of his own fat- and bone marrow-derived stem cells at Purita's clinic in 2011. In an ef- fort to revive his caner, he also used other treatments involving platelet-rich plasma from the blood, along with aggressive shoulder rehabilitation. 'I tell people that the combina- tion of those things led to me hav- ing the ability to pitch again: Nitkowsld said. "I can't definitely say that stem cells helped heal the tear—Elity rotator cuirira lowed me to pitch again. The sci- ence behind it makes sense to me, but you'll find no shortage of peo- ple that debate it' complicated. ... There's a lot that concerns. They also say process we don't know about this area of ing that isolates cells from fat tis- biology. It's why It's a hot research sue Is 'generally considered more area. It's a new frontier. We know than minimal manipulation? that there's a lot of interesting, The guidelines even say stro- potentially beneficial work to be mal vascular fraction cells — like done, but we haven't done it yet. those used by IntelliCell — in- We don't know enougft? volve processing that generally exceeds minimal manipulation. "It seemed like a warning sho to the clinics? Knoep re fler said. Yet there time and room fo debate. Victor says his company doesn't "use anything but sound waves and water and thinks his process does not violate regula- tions. 'Whether It's a drug or a cell from your own body under mini' mal manipulation, that's a low debate we're going to have? hi said. "It's a scientific debate and 4 regulatory debate that's going to go on for who knows? Purita says fat-derived stem cells are "old technology" and he, "doesn't have any fights with the FDA: He's instead using other cells, including those derived from bone marrow. The FDA says there was no time frame to finalize these guidelines. 'This is a complex issue, and the agency needs to carefully consider all comments and the -other-methods-to-parify-ancl—developingackvice-priortcrfinair idng this guidance," the FDA said in a written statement MANIPULATING DANN The kinds of stem cells being of- fered in US clinics these days are different from other, more con- troversial types of stem cell treat- ments that have been in the news in recent years. These aren't stem cells that come from embryos or the kind that hockey great Gordie Howe received in Mexico after suffering a stroke: stem cells that were derived from a fetus and an- other person's bone marrow. Instead, these US. clinics are offering autologous stem cells — stem cells that come from an adult patient's own body, usually bone marrow or fat, and are rein- serted into the same patient to help regenerate and heal the body. Such autologous cells aren't O1C for clinics to use in the USA if they've been more than "mini- malty This term is critical. After be- ing taken out of the body, US clinics typically use a centrifuge Cl. concentrate the cells. That's the whole crux of the matter? Purita said. "What is minimal manipulation?" If the cells are more than mini- mally manipulated, the treatment is going beyond FDA regulations and should be regulated as a new drug candidate. Some clinics that clearly ex- ceed the, manipulation threshold operate In other countries in- stead. In 2011, NFL quarterback Pey- ton Manning went to Europe to fo r witiristnant neck, according to media reports. Manning hasn't publicly commented on this treatment, and it's not clear how well it worked because he later WHAT'S LUNY AND NOT? In the meantime, the industry might continue to grow as the de- bate rages about whether it really works and whether it should be subject to more oversight IntelliCell's Victor thinks his Soup will be allowed but predicts other clinics will be banished be- cause they are not registered with the FDA to manufacture cellular products I_Ellinie of help ensure that Uleee estaman- ments are safe, sterile and subject to inspection. Victor says IntelliCell regis- tered its lab with the Flit oart of EFTA_R1_00019793 EFTA01735663 Arose Popuisitme An NFL defensive back recently needed medical help with a ten- don tear above his kneecap. Training camp was starting in a few wees. and he wanted the In- jury to heal faster. So in early July, he visited the clinic of Joseph Purita, a doctor In Florida with a history of help- ing athletes heal with stem cell treatments derived from bone narrow. In 2010, baseball pitcher Bartolo Colon received his treat- ment and credited it with helping revive his arm from the brink of collapse. "A good bellwether of whether these really work or not are He says he tried It because he wasn't reedy to retire and "the mentality of the athlete is gener- ally that well try almost anything to stay on the field." There's no proof it didn't work. There's no proof it did work. ei- ther. To really know if such treat- ments work by U.S standards, it would need to be treated lace a new drug candidate. In the USA. a new drug doesn't receive approv- al from the PDA for widespread use until after long and expensive clinical trials to determine its safety and efficacy. The reason these clinics aren't required to go this route is be- cause they say these cells aren't pro athletes; Punta said. "You but overall I felt better from it," drugs but rather cells that come have people who are making mil- McClain told USA TODAY Sports from a patient's body. They say lions of dollars a year. Tha go- recently "The best thing about it such treatments are essentially hog to do their research — them was that 1 healed up faster than surgeries performed in a medical and their agents. They're not go- what was' expected." office, which Isn't subject to FDA ing to do something that's bogus The clinic's doctor, Jason Wil- regulations and doesn't work Why do you llama saes positive reviews about "People would require more think athletes have embraced this treatment had spread after evidence from th.alr auto me- - shisl-Beceiase-theylenewitworiut— -hr treatted-etise-patients-coa do from these It's as simple as that' fleetest to the University of Ma- clinics," said Larry Goldstein. Purita says the con of his user- barna. But the FDA later took a professor and dire ctor of the Sart- ments ranges from $4,000 to more negative view of these ford Stem Cell Clinical Center at $7000 — a small price to pay fee enatments. it barred them. the University of California-San athletes who might be desperate prompting Williams to offer them Diego. "Human biology is really hue expert questioned whether nany clinics are even using effec- lye stem cell populations. Adding b the confusion are unclear regu- btiors from the FDA. which is tasked with helping ensure the safety and effectiveness of new drat in the USA °minder the case of Precision Sten Celt a clinic in Alebanui that treated current and former NFL players with their own fat-de- rived stem cells, including line- backer Rolando McClain. Now with the Dallas Cowboys, Mc- Cla4used it to treat a high ankle sp after the 2011 season. don't know if It was the actu- ally stem cells or just mentally, had neck surgery. Goldstein adds another note of skepticism about US. clinics. If these stem cells are more than minimally manipulated, they're not legal in these U.S. clinics. But if they're not more than minimal- ly manipulated, he questions whether they're producing pure, effective stem cell populations. 'There could be some excep- tion out there, but, realistically, it's unlikely" he said. "It's unlikely in the extreme that these mini- mally manipulated methods are producing a stem cell population that is therapeutically beneficial. There's just no evidence for it." 'WARNING SHOT The FDA recently issued draft guidelines to help bring some clarity to the field — recommen- dations that didn't seem to bode well for the many U.S. clinics that harvest their cells from adipose or fat The p ...sed guidelines say that using cells from fit tissue to treat bone and joint disease ap- pears to go beyond what nature intended for those cells, exceed- ing regulations and raising safety a c8thplamted and expensive compliance process. "That's what makes our stuff so expensive," he said. By contrast, Victor says almost all stem cell clinics are not regis- tered because they say it's not necessary. Such clinics argue they are not 'manufacturing' and in- stead are performing a surgical procedure not subject to FDA rules. A big question Is how the FDA can keep up with the labs and technology, helping patients know what works and what doesn't, what's safe and what might not be. It won't be easy. it's hard to write good law and regulation that allows legitimate work to proceed as rapidly as pos- sible while prohibiting illegiti- mate work," said Goldstein of UCSD. Wart of the problem is it is a new area of medicine where the regulations didn't anticipate this sort of thing. The regulators on the ground in the field, they airway:ma don't have advents background to tell what's legit and what's not. It's hard? Contributhe .harr•tt Boa EFTA R1 00019794 EFTA01735664