EFTA01735661.pdf

EFTA01735661 s. a 0 DNESDAY. SEPTEMBER 2.2015 THE NATION'S NEWS USA USA TODAY TOGA TM SPORTS. 09.02.1if A GANNETT COMPANY `Soup' therapy promises healing strouroas. motor scan Treatment touted as surgery alternative --Clbsieespealala let Lisa Santia- - amid effectivenessand legal concerns go works in knees, elbows, Florida for Brent fichrotenbocr hips, necks and Joseph Perils, (aSchrotenhier • more. who has a his- USA TODAY Spans "Traditional otfhelping taaee heal with stem cell Pbr a minimum price of medicine and traditional STEM CELLS treatments. $15,000, several professional ath- AND SPORTS =for d: lotnotf letes recently received a curious new medical treatment ha New patients," said York. Steven Victor, founder and chair- It's called "The Soup" — &mix- man of The Soup's manufacturer, ture of human cells that includes IntelitCell ftioSciences "This stem cells derived from a pa- kind of cellular therapy can really dent's own fat If It works the way be a savior to them!' thy-holmTheSoup mai* re- It's an exploding field. Just a pair injuries that otherwise might require surgery — damaged ► STOltV CONTINUES ON  EFTA01735662 EFTA_R1_00019792 USA 'FORM 6C SPORTS WEDNESDAY, SEPTEMBER 2.201° SUM CELLS Ally SPORTS 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 MO watt WA TOOK, VON factor, along with Baby Boomers looking for alternatives to sur- Steven Victor. founder of intellifell BioScience, . c.t..idipom. i-sue fr a patient at tteGen Medical in New York. ge-Us—  `As the number of professional to paling their careen. complicated. ... There's a lot that concerns. They also say process EFTA01735663 trCA 9 1.4 athletes getting stem cell treat- Purita declined to name the 4 04- i Z. we don't know about this area of ing that isolates cells from fat tis- EFTA_R1_00019793 ments continua to climb ... I NFL player who received treat- ,t .4- 4 4 biology.It's why It's a hot research sue Is 'generally considered more think the number of ordinary ment in July. Many of them have '4' area. It's a new frontier. We know than minimal manipulation? people is likely going to continue wanted to keep such treatments that there's a lot of interesting, The guidelines even say stro- to climb, too? Knoepfler said. secret, largely because team man- • •t potentially beneficial work to be mal vascular fraction cells — like Such growth is a concern, ex- agement might disapprove of Ix, done, but we haven't done it yet. those used by IntelliCell — in- pert say, because the market for such alternative medicine. We don't know enougft? volve processing that generally these clinics appears to have - This can affect their contract outside the country — in Bogota, exceeds minimal manipulation. rocketed beyond the boundaries negotiations and all kinds of Colombia. MANIPULATING DANN "It seemed like a warning sho of government regulation and es- things, and so some guys come 'The FDA made me sign an The kinds of stem cells being of- to the clinics? Knoepfler said. tablished science. without the team even knowing," agreement that I wouldn't do that fered in US clinics these days are Yet there re time and room fo Take IntelliCell, for example. Purita said. 'They don't want the anymore in the United States" different from other, more con- debate. Victor says his company The company's recent history team to know, so we Just kind of Williams said. troversial types of stem cell treat- doesn't "use anything but sound shows the risks of operating in keep it quiet? He says the FDA had an issue ments that have been in the news waves and water and thinks his this vast new medical frontier, Victor says his sports clients with him using fat-derived cells in recent years. These aren't stem process does not violate regula- where the law has been vague and also didn't want to be named but for these purposes. cells that come from embryos or tions. treatments haven't been scientifi- adds that teams have become "We were doing the same thing the kind that hockey great Gordie 'Whether It's a drug or a cell cally proved. more accepting of this treatment everybody else was doing, I Howe received in Mexico after from your own body under mini' In March 2012, the FDA Issued in recent years. IntelliCell's list of think? Williams said, referring to suffering a stroke: stem cells that mal manipulation, that's a low a warning to Victor, saying Intel- medical advisers includes doctors similar clinics using fat-derived were derived from a fetus and an- debate we're going to have? hi liCell's product violated the law for the Oakland Raiders, New stem cells. "It's just that we be- other person's bone marrow. said. "It's a scientific debate and 4 and should be considered a new York Rangers and Andrews, who came kind of known a little more Instead, these US. clinics are regulatory debate that's going to drug — a designation that would had planned to use the IntelliCell quickly than some of these other offering autologous stem cells — go on for who knows? require long and expensive clini- product at a lab in Florida An- at" stem cells that come from an Purita says fat-derived stem cal trials to determine whether drews didn't return several mes- The FDA declined to comment adult patient's own body, usually cells are "old technology" and he, it's safe and affective for public sages seeking a comment. on the case, leaving questions un- bone marrow or fat, and are rein- "doesn't have any fights with the occaumption. He and others have said they answered about how this clinic serted into the same patient to FDA: He's instead using other Former IntelliCell employees think cellular therapy is the cut- was manipulating stem cells dif- help regenerate and heal the cells, including those derived also recently filed two federal ting edge of sports medicine, a ferently than other US clinics body. Such autologous cells aren't from bone marrow. lawsuits against the company, ac- way to avoid surgery and heal that offer similar fat-derived stem O1C for clinics to use in the USA if The FDA says there was no cusing Victor of making false faster more naturally. Hoge, the cell treatments. they've been more than "mini- time frame to finalize these statements about his product and former running back, says a liga- malty guidelines. manipulating data to boost its ment in his right elbow was 60% I CANT DIPINIMILY SAY' This term is critical. After be- 'This is a complex issue, and prospects — accusations he says torn but healed in six weeks after McClain isn't the only athlete ing taken out of the body, US the agency needs to carefully are bogus. receiving stromal who can't say for certain if the clinics typically use a centrifuge consider all comments and the --bfeanwitliedireartelal-problems—vascularfeaction an -fee- Cl.-other-methods-to-parify-ancl—developingackvice-priortcrfinair have increased Last year, Intent- tific name of The Souµ tors helped instead. concentrate the cells. idng this guidance," the FDA said Cell — which is publicly traded — After fat tissue was extracted Former pitcher CJ. Nitkowsld That's the whole crux of the in a written statement reported an accumulated deficit from his side in New York, sound says he paid about 112200 to get matter? Purita said. "What is of $64 million. waves were used to separate the an injection of his own fat- and minimal manipulation?" WHAT'S LUNY AND NOT? Yet Victor Isn't backing down. cells from the fat The cells were bone marrow-derived stem cells If the cells are more than mini- In the meantime, the industry Unlike other cellular therapy injected into his elbow in a bid to at Purita's clinic in 2011. In an ef- mally manipulated, the treatment might continue to grow as the de- clinics, Victor says his company is help it regenerate and heal. fort to revive his caner, he also is going beyond FDA regulations bate rages about whether it really doing things the right way, ac- 'Stem cell therapy is your body used other treatments involving and should be regulated as a new works and whether it should be cording to the law, because his lab healing yourself; Hoge said. 'For platelet-rich plasma from the drug candidate. subject to more oversight is registered with the FDA. me, it worked out beautifully, and blood, along with aggressive Some clinics that clearly ex- IntelliCell's Victor thinks his ;If you look et other (stem aril I avoided a Emery. I avoided shoulder rehabilitation. ceed the, manipulation threshold Soup will be allowed but predicts clinics), they're kind of winging six-month rehab process. I was 'I tell people that the combina- operate In other countries in- other clinics will be banished be- it," said Victor, a cosmetic derma- completely better in six weeks tion of those things led to me hav- stead. cause they are not registered with tologist and self-described mad versus six months? ing the ability to pitch again: In 2011, NFL quarterback Pey- the FDA to manufacture cellular scientist. "They don't really fol- Nitkowsld said. "I can't definitely ton Manning went to Europe to products IowafpAsits.'L „MALI say that stem cells helped heal witiristnant I_Ellinie of But beanie it's such a new and Yet quations pant out this the tear —Elity rotator cuirira fo r neck, according to help ensure that Uleee estaman- rapidly evolving field. it's hard to and similar treatments because lowed me to pitch again. The sci- media reports. Manning hasn't ments are safe, sterile and subject tell who's right, what works and they have not undergone enough ence behind it makes sense to me, publicly commented on this to inspection. what doesn't. rigorous testing to determine but you'll find no shortage of peo- treatment, and it's not clear how Victor says IntelliCell regis- their safety and effectiveness. ple that debate it' well it worked because he later tered its lab with the Flit oart of  EFTA01735664 EFTA R1 00019794 y. a c8thplamted and expensive hue expert questioned whether He says he tried It because he had neck surger process. "That's what Arose Popuisitme Goldstein adds another note of compliance An NFL defensive back recently nany clinics are even using effec- wasn't reedy to retire and "the skepticism about US. clinics. If makes our stuff so expensive," he gener- needed medical help with a ten- lye stem cell populations. Adding mentality of the athlete is ng these stem cells are more than said. don tear above his kneecap. b the confusion are unclear regu- ally that well try almost anythi minimally manipulated, they're By contrast, Victor says almost Training camp was starting in a btiors from the FDA. which is to stay on the field." not regis- U.S. clinics. But all stem cell clinics are few wees. and he wanted the In- tasked with helping ensure the There's no proofit didn't work. not legal in these because they say it's not work. ei- if they're not more than minimal- tered jury to heal faster. safety and effectiveness of new There's no proof it did , he questions necessary. Such clinics argue they So in early July, he visited the drat in the USA ther. To really know if such treat- ly manipulated producing pure, are not 'manufacturing' and in- rds, it wheth er they're clinic of Joseph Purita , a docto r °mind er the case of Precision ments work by U.S standa effecti ve stem cell populations. stead are performing a surgical In Florida with a history of help- StenCelt a clinic in Alebanui that would need to be treated lace a 'There could be some excep- procedure not subject to FDA ing athletes heal with stem cell treated current and former NFL new drug candidate. In the USA. a tion out there, but, realistically, rules. approv- treatments derived from bone players with their own fat-de- new drug doesn't receive read it's unlikely" he said. "It's unlikely A big question Is how the FDA narrow. In 2010, baseball pitcher rived stem cells, including line- al from the PDA for widesp keep up with the labs and sive in the extreme that these mini- can Bartolo Colon received his treat- backe r Rolando McClain. Now use until after long and expen its mally manip ulated metho ds are technology, helping patients ment and credited it with helping with the Dallas Cowboys, Mc- clinical trials to determine producing a stem cell population know what works and what revive his arm from the brink of Cla4used it to treat a high ankle safety and efficacy. lly beneficial. doesn't, what's safe and what collapse. sp after the 2011 season. The reason these clinics aren't that is therapeutica ce for it." might not be.It won't be easy. is be- There's just no eviden "A good bellwether of whether don't know ifIt was the actu- required to go this route aren't it's hard to write good law and cells regulation that allows legitimate these really work or not are ally stem cells or just mentally, cause they say these come 'WARNING SHOT pro athletes; Punta said. "You but overall I felt better from it," drugs but rather cells that say The FDA recently issued draft work to proceed as rapidly as pos- have people who are making mil- McClain told USA TODAY Sports from a patient's body. Theytially guidelines to help bring some sible while prohibiting illegiti- lions of dollars a year. Tha go- recently "The best thing about it such treatments are essen said Goldstein of clarity to the field — recommen- mate work,"of the problem is it is hog to do their research — them was that 1 healed up faster than surgeries performed in a medical seem to bode UCSD. Wart office, which Isn't subject to FDA dations that didn't of medicine where the and their agents. They're not go- what was' expected." well for the many U.S. clinics that a new area ate this ing to do something that's bogus The clinic's doctor, Jason Wil- regulations from adipose regulations didn't anticip and doesn't work Why do you llama saes positive reviews about "People would require more harvest their cells sort of thing. The regulators on me- or fat think athletes have embraced this treatment had spread after evidence from th.alr auto in the field, they The p ...sed guidelines say the grounddon't have advents - shisl-Beceiase-theylenewitworiut— -hr treatted-etise-patients-coa do from these airway:ma tein. that using cells from fit tissue to background to tell what's legit It's as simple as that' fleetest to the University of Ma- clinics," said Larry Golds the Sart- treat bone and joint disease ap- and what's not. It's hard? Purita says the con of his user- barna. But the FDA later took a professor and dire ctor of r at pears to go beyond what nature ments ranges from $4,000 to more negative view of these ford Stem Cell Clinical Cente intended for those cells, exceed- $7000 — a small price to pay fee enatments. it barred them. the University of California-San ing regulations and raising safety Contributhe .harr•tt Boa really athletes who might be desperate prompting Williams to offer them Diego. "Human biology is