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Funding windfall rescues abandoned stem-cell trial
A?landmark?stem-cell?trial?is?sputtering back?to?life?two-and-a-half?years?afterit?was?abandoned?by?the?Californiacompany?that?started?it.?But?it?now?faces?afresh?set?of?challenges,?including?a?field?that?ispacked?with?competitors.The?trial?aims?to?test?whether?cellsderived?from?human?embryonic?stemcells?can?help?nerves?to?regrow?in?casesof?spinal-cord?injury.?It?was?stoppedabruptly?in?2011?by?Geron?ofNature?479,?459;?2011);?thefirm
said?at?the?time?that?itwanted?to?focus?on?severalpromising?cancer?treatmentsinstead.?Now,?a?new?company—?Asterias?Biotherapeutics,?alsoof?Menlo?Park?—?plans?to?resurrectthe?trial?with?a?US$14.3-milliongrant?that?it?received?on?29?May?from?theCalifornia?Institute?for?Regenerative?Medicine(CIRM),?the?state’s?stem-cell-funding?agency.But?the?field?has?moved?on?since?Gerontreated?its?first?patient?in?2010,?and?the?therapythat?Asterias?inherited?is?no?longer?the?onlypossibility?for?spinal-cord?injury.?StemCells,?abiotechnology?company?in?Newark,?California,has?treated?12?patients?in?a?safety?studyof?a?different?type?of?stem?cell,?and?it?plans?tostart?a?more?advanced?trial?this?year?to?testeffectiveness.?And?another?entrant?to?thefield,?Neuralstem?of?Germantown,?Maryland,received?regulatory?approval?in?January?2013to?begin?human?tests?of?its?stem-cell?product.Geron’s?human?trial?was?the?first?approved?touse?cells?derived?from?human?embryonic?stemcells.?But?regulators?halted?it?twice,?once?citingconcerns?about?the?purity?and?predictability?ofthe?cells?being?implanted,?and?again?after?thecompany?reported?seeing?microscopic?cysts?inthe?spinal?cords?of?rats?that?had?been?treated?inpreclinical?studies.?The?worry?was?that?the?cystscould?be?teratomas?—?uncontrolled?growthsthat?can?form?from?embryonic?stem?cells,?afeared?side?effect?of?treatment.?Geron?later?saidthat?the?growths?were?not?teratomas,?and?theUS?Food?and?Drug?Administration?allowed?thetrial?to?
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