RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2018-10-24

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03588975

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.

Ages Eligible for Study:10 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Mikhail Chkolnik, MD

CONTACT

484-387-2257

mchkolnik@vcel.com

Kristin M Tripp, BS

CONTACT

ktripp@vcel.com

Principal Investigator

Jonathan Hopper

STUDY_DIRECTOR

Vericel Corporation

Study Locations (Sites)

Stanford University

Palo Alto, California, 94304

United States

Shriner's Hospital for Children Northern California

Sacramento, California, 95817

United States

University of California Davis Health

Sacramento, California, 95817

United States

Ochsner Sports Medicine Institute

New Orleans, Louisiana, 70121

United States

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21224

United States

University of Michigan

Ann Arbor, Michigan, 48106

United States

Akron Children's Hospital

Akron, Ohio, 44308

United States

The Ohio State University Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Penn Sports Medicine Center

Philadelphia, Pennsylvania, 19104

United States

Texas Children's Hospital

Houston, Texas, 77094

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53201

United States

Collaborators and Investigators

Sponsor: Vericel Corporation

Jonathan Hopper, STUDY_DIRECTOR, Vericel Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-24

Study Completion Date2027-06

Study Record Updates

Study Start Date2018-10-24

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

OCD
cartilage
cartilage defect

Additional Relevant MeSH Terms

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