FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month af­ter fil­ing the IND ap­pli­ca­tion for its hu­man ex­tra­cel­lu­lar ma­trix de­signed to re­gen­er­ate knee car­ti­lage, His­to­gen has hit a road­block.

The FDA on Tues­day ver­bal­ly no­ti­fied the San Diego-based biotech that it was plac­ing a clin­i­cal hold on the planned Phase I/II clin­i­cal tri­al of HST-003 due to pend­ing CMC in­for­ma­tion and ad­di­tion­al ques­tions need­ed to com­plete their re­view.

His­to­gen had planned to test the safe­ty and ef­fi­ca­cy of im­plant­i­ng hECM with­in mi­crofrac­ture in­ter­stices and re­lat­ed car­ti­lage de­fects to re­gen­er­ate that car­ti­lage in con­junc­tion with a mi­crofrac­ture pro­ce­dure. The com­pa­ny said in a press re­lease that it ex­pects to re­ceive writ­ten no­tice of the clin­i­cal hold from the FDA by Feb 12.

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