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

Part of paid clinical trials in Sacramento, California.

Sponsor
Vericel Corporation
Study ID
NCT06915233
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Articular Cartilage Defect
  • Chondral Defect

Eligibility Criteria

Sex
ALL
Age
17 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • autologous cultured chondrocytes on porcine collagen membrane — BIOLOGICAL
    An autologous cellularized scaffold combination 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.
  • Bone Marrow Stimulation — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Apr 8, 2025
Start date
May 28, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
309 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MACI
    autologous cultured chondrocytes on porcine collagen membrane
  • Other: Bone Marrow Stimulation
    Surgical procedure

Primary Outcome Measure

Change from Baseline to Week 104 in the FAOS Pain and Function (SRA) subscale scores [ Time Frame: Baseline to Week 104 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
UC Davis Foot and Ankle ClinicSacramentoCalifornia95816
Leslie Mellor
[email protected]
916-826-8135
Eric Giza, MD (PRINCIPAL_INVESTIGATOR)
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Joshua Lawrence
[email protected]
240-863-1681
Nicholas Casscells, MD (PRINCIPAL_INVESTIGATOR)
Elevate Clinical Research WichitaWichitaKansas67226
Tara Bocquet
[email protected]
832-225-2937
Jon Morgan, MD (PRINCIPAL_INVESTIGATOR)
Duke Orthopaedic SurgeryDurhamNorth Carolina27705
Suzanne Finley
[email protected]
919-684-5431
Annunziato Amendola, MD (PRINCIPAL_INVESTIGATOR)
Elevate Clinical ResearchHoustonTexas77058
Tara Bocquet
[email protected]
832-225-2937
Jesus Juarez, MD (PRINCIPAL_INVESTIGATOR)
Rodaro, LLCSan AntonioTexas78251
Carrisa Bolado
[email protected]
210-689-8287
Robert Farber, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Eric McVey
[email protected]
434-243-5382
Minton Truitt Cooper, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By research site
UC Davis Foot and Ankle Clinic· Sacramento, CAMedStar Georgetown University Hospital· Washington D.C., DCElevate Clinical Research Wichita· Wichita, KSDuke Orthopaedic Surgery· Durham, NCElevate Clinical Research· Houston, TXRodaro, LLC· San Antonio, TX

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