Cell therapy for knee cartilage damage did not meet primary endpoint in phase 3 trial

Histogenics Corporation announced in a press release that the phase 3 clinical trial of its restorative cell therapy NeoCart did not meet its primary endpoint of statistically significant improvement in pain and function 1 year after treatment compared with a microfracture in a dual-threshold responder analysis of patients with knee cartilage damage.

However, results of a modified intent-to-treat population at 6 months showed patients treated with NeoCart compared with those treated with microfracture had achieved statistically significant improvements in pain and function. Both NeoCart and microfracture were well tolerated and demonstrated strong safety profiles, according to the release.

Investigators collected patient-reported outcomes such as the KOOS and IKDC score. Dual-threshold responders included patients who, compared with baseline measurement, had at least a 12-point improvement in KOOS pain sub-score assessment and a 20-point improvement in the IKDC subjective assessment.

In patients treated with NeoCart, the mean lesion size was 2.1 cm. The mean lesion size was 1.8 cm in patients treated with microfracture. No other statistical differences were seen between treatment groups.

“We are as committed as ever to bringing NeoCart to our patients and surgeons,” Adam Gridley, the president and CEO of Histogenics told Healio.com/Orthopedics. “Based on the totality of the phase 3 data, we intend to work closely with FDA to define our potential [biologics license application] BLA submission strategy. Patients treated with NeoCart displayed an earlier and sustained recovery from pain and return to function at 6 months. This is consistent with the feedback we have received from many of our surgeons who reported that their patients felt like they got their life back earlier and were able to do things they couldn’t do before the procedure.”

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