A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients With Symptomatic Chondral or Osteochondral Lesions of the Talus (MASCOT)

Summary

The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with symptomatic articular chondral or osteochondral defects of the talus.

Description

Eligibility

Age range

17–65 years

Sex

All

Healthy volunteers

No

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.

Locations (4)