A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee

Description

The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of patients aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.

Conditions

Chondral Defect, Osteochondritis Dissecans (OCD), Articular Cartilage Defect, Articular Cartilage Disorder of Knee

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Study Overview

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Study Details

Study overview

The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of patients aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.

A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee

A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee

Condition
Chondral Defect
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Sacramento

Shriner's Hospital for Children Northern California, Sacramento, California, United States, 95817

Sacramento

University of California Davis Health, Sacramento, California, United States, 95817

New Orleans

Ochsner Sports Medicine Institute, New Orleans, Louisiana, United States, 70121

Baltimore

Johns Hopkins Outpatient Center, Baltimore, Maryland, United States, 21224

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48106

Akron

Akron Children's Hospital, Akron, Ohio, United States, 44308

Columbus

The Ohio State University Jameson Crane Sports Medicine Institute, Columbus, Ohio, United States, 43202

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Penn Sports Medicine Center, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Symptomatic cartilage or osteochondral defects
  • * One or more International Cartilage Repair Society (ICRS) Grade III or IV chondral or unsalvageable osteochondral defects located on the femoral condyles and/or trochlea amenable to treatment with the surgical procedure determined at randomization (MACI or microfracture).
  • * At least 1 defect size ≥1.5 cm2 on the femoral condyles and/or the trochlea; defects include OCD lesions with a bone lesion depth of ≤6 mm and does not require a bone graft.
  • * Stable target knee (i.e., anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact). Ligament repair or reconstruction procedures are allowed prior to screening arthroscopy.
  • * Intact meniscus or partial meniscus (at least 50% of functional meniscus remaining) in the target knee.
  • * Any surgery on the target knee joint within 6 months prior to Screening (not including diagnostic arthroscopy)
  • * ICRS Grade III or IV chondral or unsalvageable osteochondral defects located on the patella or tibia or any lesion that is bipolar to the index lesion
  • * Concomitant inflammatory disease or other conditions that affects the joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis)
  • * Known history of septic arthritis in the index knee joint
  • * Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
  • * Females who are pregnant or lactating

Ages Eligible for Study

10 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vericel Corporation,

Jonathan Hopper, STUDY_DIRECTOR, Vericel Corporation

Study Record Dates

2027-06