FDA press­es its cam­paign against rogue re­gen­er­a­tive med play­ers, cites Stem­Genex for il­le­gal sales

The FDA’s cam­paign against the “bad ac­tors” op­er­at­ing in re­gen­er­a­tive med­i­cine is far from com­plete.

The reg­u­la­tor on Tues­day ad­mon­ished San Diego-based Stem­Genex Bi­o­log­ic Lab­o­ra­to­ries LLC for mar­ket­ing an un­ap­proved stem cell prod­uct and point­ed out sig­nif­i­cant vi­o­la­tions that could cor­rupt the man­u­fac­tur­ing process, po­ten­tial­ly cul­mi­nat­ing in mi­cro­bial con­t­a­m­i­na­tion that put pa­tients at risk.

The crack­down on clin­ics sell­ing re­gen­er­a­tive med­i­cines for a host of un­ap­proved in­di­ca­tions con­tin­ues to gath­er steam, as the agency makes good on its 2017 promise to en­sure un­scrupu­lous play­ers mar­ket­ing un­proven and of­ten dan­ger­ous prod­ucts are held to ac­count.

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