RecruitingPhase 3NCT03588975

A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic 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

Sponsor

Vericel Corporation

Enrollment

45 participants

Start Date

Oct 24, 2018

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called MACI and a procedure called microfracture for people with articular cartilage defect, articular cartilage disorder of knee, and other related conditions. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 10 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMACI

autologous cultured chondrocytes on porcine collagen membrane

PROCEDUREmicrofracture

Arthroscopic microfracture treatment

Locations(14)

Stanford University School of Medicine

Palo Alto, California, United States

Shriners Hospital for Children Northern California

Sacramento, California, United States

University of California Davis Health

Sacramento, California, United States

Ochsner Sports Medicine Institute

New Orleans, Louisiana, United States

Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

University of Michigan Medsport Orthopaedic Surgery

Ann Arbor, Michigan, United States

Montefiore Medical Center/Albert Einstein College of Medicine

The Bronx, New York, United States

Akron Children's Hospital

Akron, Ohio, United States

The Ohio State University Jameson Crane Sports Medicine Institute

Columbus, Ohio, United States

Penn Medicine University City

Philadelphia, Pennsylvania, United States

The Children's Hospital of Philadelphia - The Hub for Clinical Collaboration

Philadelphia, Pennsylvania, United States

Texas' Children Hospital

Houston, Texas, United States

Children's Medical Center Plano

Plano, Texas, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT03588975

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