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NCT03588975Phase 3RECRUITING

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

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 DefectOsteochondritis Dissecans (OCD)Articular Cartilage DefectArticular Cartilage Disorder of Knee
Interventions / Drugs
MACImicrofracture
View on ClinicalTrials.gov ↗
Sponsor
VCEL
Vericel Corporation
Regenerative Medicine
D39/100
Study Details
Enrollment45 participants
Primary Completion—
Lead SponsorVericel Corporation
Data Retrieved2026-04-11 04:30:51.495467+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 45 participants
Sponsor Catalyst Profile

Vericel Corporation (VCEL) is the sponsoring company for this trial. BiotechSign currently grades this company D (39/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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