A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

309

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

April 30, 2030

Study Completion Date

April 30, 2030

Conditions
Chondral DefectArticular Cartilage Defect
Interventions
BIOLOGICAL

autologous cultured chondrocytes on porcine collagen membrane

An autologous cellularized scaffold product being studied for the repair of symptomatic, single or multiple full-thickness cartilage defects of the talus with or without bone involvement in adults.

PROCEDURE

Bone Marrow Stimulation

"A surgical awl or microdrill will be used to make multiple holes in the exposed base of the lesion. The microfracture procedure should result in holes that are approximately 3 to 4 mm apart.~When fat droplets can be seen coming from the marrow cavity, the appropriate depth (approximately 2 to 4 mm) has been reached.~The released marrow elements (including mesenchymal stem cells, growth factors, and other healing proteins) form a surgically induced clot that provides an enriched environment for new tissue formation."

All Listed Sponsors
lead

Vericel Corporation

INDUSTRY