Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03588975
PHASE3

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

Sponsor: Vericel Corporation

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2018-10-24

Completion Date

2027-06

Last Updated

2024-12-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

MACI

autologous cultured chondrocytes on porcine collagen membrane

PROCEDURE

microfracture

Arthroscopic microfracture treatment

Locations (12)

Stanford University

Palo Alto, California, United States

Shriner's 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

Ann Arbor, Michigan, United States

Akron Children's Hospital

Akron, Ohio, United States

The Ohio State University Jameson Crane Sports Medicine Institute

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Penn Sports Medicine Center

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States