For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Symptomatic cartilage or osteochondral defects
  2. 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).
  3. 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.
  4. 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.
  5. Intact meniscus or partial meniscus (at least 50% of functional meniscus remaining) in the target knee.

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Any surgery on the target knee joint within 6 months prior to Screening (not including diagnostic arthroscopy)
  2. 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
  3. Concomitant inflammatory disease or other conditions that affects the joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis)
  4. Known history of septic arthritis in the index knee joint
  5. Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
  6. Females who are pregnant or lactating
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 484-387-2257Email iconEmail Study Center

Study Details


Contition

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

Age

10 - 17

Phase

PHASE3

Participants Needed

45

Est. Completion Date

Jun 30, 2027

Treatment Type

INTERVENTIONAL


Sponsor

Vericel Corporation

ClinicalTrials.gov NCT Identifier

NCT03588975

Study Number

55-1702-1

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