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

NCT06915233 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Chondral Defect
  • Articular 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.

Sponsors & Collaborators

  • Vericel Corporation

    lead INDUSTRY

Principal Investigators

  • Jonathan Hopper BSc (Hons), MB ChB, FRCSEd, DIMC RCSEd., MBA, BSc (Hons), MB · Vericel Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2030-07-31
Completion
2030-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06915233 on ClinicalTrials.gov