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 Washington D.C., District of Columbia.

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

Start date
May 31, 2026
Status verified
May 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
  • Active Comparator: 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 (4)

FacilityCityStateZIPSite coordinators
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Joshua Lawrence
[email protected]
240-863-1681
Nicholas Casscells, MD (PRINCIPAL_INVESTIGATOR)
Elevate Clinical Research Wichita - Kansas Joint and Spine specialistsWichitaKansas67226
Tara Bocquet
[email protected]
832-225-2937
Jon Morgan, MD (PRINCIPAL_INVESTIGATOR)
Elevate Clinical Research Houston - All American Orthopedic and Sports MedicineHoustonTexas77058
Tara Bocquet
[email protected]
832-225-2937
Jesus Juarez, MD (PRINCIPAL_INVESTIGATOR)
San Antonino Podiatry AssociatesSan AntonioTexas78251
Carrisa Bolado
[email protected]
210-689-8287
Robert Farber, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
MedStar Georgetown University Hospital· Washington D.C., DCElevate Clinical Research Wichita - Kansas Joint and Spine specialists· Wichita, KSElevate Clinical Research Houston - All American Orthopedic and Sports Medicine· Houston, TXSan Antonino Podiatry Associates· San Antonio, TX

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