U.S. cracks down on ‘un­scrupu­lous’ stem cell clin­ics

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The FDA said pa­tients at the Cal­i­for­nia Stem Cell Treat­ment Centers in Ran­cho Mi­rage and Bev­erly Hills, Cal­i­for­nia, re­ceived the treat­ment made with the small­pox vac­cine. It also said it had se­ri­ous con­cerns about how StemIm­mune ob­tained the vac­cine for use in an un­ap­proved and po­ten­tially dan­ger­ous treat­ment.

StemIm­mune ob­tained at least some of the vac­cine from the Centers for Dis­ease Con­trol and Preven­tion, ac­cord­ing to Thomas Skin­ner, a CDC spokesman. In its re­quest, the com­pany said it was con­duct­ing cancer re­search in­volv­ing the vac­cinia virus, and needed to vac­ci­nate re­searchers — a seem­ingly le­git­i­mate rea­son. The com­pany did not tell the CDC that it was go­ing to in- ject the vac­cine into pa­tients, he said.

A state­ment from StemIm­mune said the com­pany had lawfully ob­tained the drug.

The FDA also is­sued a warn­ing letter to U.S. Stem Cell, a pri­vate clinic in Sun­rise, Florida. The com­pany was the sub­ject of a March re­port in The New Eng­land Jour­nal of Medicine, de­scrib­ing how one wo­man went blind and two oth­ers suf­fered se­vere, per­ma­nent eye dam­age af­ter be­ing given shots of stem cells, ex­tracted from fat, into their eyes.

The warn­ing letter ac­cused the com­pany of im­pair­ing the FDA’s abil­ity to con­duct its in­spec­tion by re­fus­ing to al­low in­spec­tors in, and deny­ing them ac­cess to em­ploy­ees. It also said that U.S. Stem Cell had failed to es­tab­lish proper qual­ity con­trol and san­i­tary stan­dards.

In a state­ment Mon­day af­ter­noon, U.S. Stem Cell de­nied ever restrict­ing ac­cess to FDA in­spec­tors, or hav­ing steril­ity prob­lems. “The safety and health of our pa­tients are our num­ber one pri­or­ity and the strict stan­dards that we have in place fol­low the laws of the Food and Drug Ad­min­is­tra­tion,” it said.

Not­ing that the FDA has asked pa­tients with con­cerns to come for­ward, the com­pany said it had asked pa­tients who have had pos­i­tive ex­pe­ri­ences with their stem cell treat­ments to no­tify the agency.

But in the warn­ing letter, the FDA noted that U.S. Stem Cell had claimed its work was not sub­ject to agency reg­u­la­tion. The FDA dis­agreed, say­ing that the cells ex­tracted by the com­pany met the def­i­ni­tion of both a drug and a bi­o­log­i­cal prod­uct, both of which come un­der the agency’s ju­ris­dic­tion. In its state­ment, U.S. Stem Cell said it would abide by the new rules the agency is de­vel­op­ing for the field.

Got­tlieb said it was im­per­a­tive to shut down fraud­u­lent and un­safe play­ers in the field in or­der to take ad­van­tage of the prom­ise of stem cell ther­a­pies and to in­crease in­no­va­tion in the re­gen­er­a­tive medicine field, a pro­gram au­tho­rized by Congress in the 21st Cen­tury Cures Act.

Those en­ter­prises “put the en­tire field at risk,” Got­tlieb said. “Prod­ucts that are re­li­ably and care­fully de­vel­oped will be harder to ad­vance if bad ac­tors are able to make hol­low claims and mar­ket un­safe sci­ence.”

The Cal­i­for­nia Stem Cell Treat­ment Centers were founded in 2010 by Dr. Mark Ber­man, a plas­tic sur­geon, and Dr. El­liot Lan­der, a urol­o­gist. Ber­man de­fended the com­pany, and said that the FDA had not ac­cu­rately in­ter­preted its cancer pi­lot study with StemIm­mune. Ber­man, who is also a di­rec­tor of StemIm­mune, also said that none of the pa­tients had ex­pe­ri­enced se­ri­ous ad­verse ef­fects or died as a re­sult of the treat­ment in­volv­ing the vac­cine, which he noted, was free.

Got­tlieb said the FDA would soon pub­lish doc­u­ments de­tail­ing which new treat­ments and prod­ucts are sub­ject to agency reg­u­la­tion, and which are not, and giv­ing de­tails on a new, ex­pe­dited path for com­pa­nies with le­git­i­mate prod­ucts, seek­ing pre­mar­ket ap­proval.

Some in­dus­try rep­re­sen­ta­tives ap­plauded the move.

“The FDA’s pro­posal is clear ev­i­dence of the fact that the re­gen­er­a­tive medicine sec­tor has ma­tured and has moved from just a re­search sec­tor to a de­vel­op­ment of mar­ket ready prod­ucts,” said Michael Werner, a part­ner in the law firm of Hol­land & Knight and the ex­ec­u­tive di­rec­tor of the Al­liance for Re­gen­er­a­tive Medicine. “He’s clearly dis­tin­guish­ing un­scrupu­lous ac­tors who are play­ing upon hype and tak­ing ad­van­tage of pa­tients and prod­uct developers who are ac­tu­ally go­ing to treat dis­eases.”

“He is try­ing to bal­ance pa­tient safety and a reg­u­la­tory path­way that is as least bur­den­some as pos­si­ble,” Werner said.

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