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

NCT03588975 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

MACI

autologous cultured chondrocytes on porcine collagen membrane

PROCEDURE

microfracture

Arthroscopic microfracture treatment

Sponsors & Collaborators

  • Vericel Corporation

    lead INDUSTRY

Principal Investigators

  • Jonathan Hopper · Vericel Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03588975 on ClinicalTrials.gov