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NCT03588975 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Chondral Defect and Articular Cartilage Defect, sponsored by Vericel Corporation.

Recruiting
Registry status
Phase 3
Development phase
45
Enrollment target
12
Study locations

NCT03588975 is a Phase 3 study of Chondral Defect and Articular Cartilage Defect that is actively recruiting participants, run by Vericel Corporation. The registered enrollment target is 45 participants, below the 290-participant average among 3 other Chondral Defect trials with a reported enrollment target (84% lower). The trial reports 12 study locations across 8 states.

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The verdict

NCT03588975, a Phase 3 study of Chondral Defect and Articular Cartilage Defect, is actively recruiting participants, sponsored by Vericel Corporation.

RECRUITING
Registry status
Phase 3
Development phase
45 participants
Enrollment target
12
Study locations

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.

Interventions

  • BIOLOGICAL MACI
  • PROCEDURE microfracture

Study Locations (12)

California

  • Stanford University - Palo Alto
  • Shriner's Hospital for Children Northern California - Sacramento
  • University of California Davis Health - Sacramento

Ohio

  • Akron Children's Hospital - Akron
  • The Ohio State University Jameson Crane Sports Medicine Institute - Columbus

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia
  • Penn Sports Medicine Center - Philadelphia

Louisiana

  • Ochsner Sports Medicine Institute - New Orleans

Maryland

  • Johns Hopkins Outpatient Center - Baltimore

Michigan

  • University of Michigan - Ann Arbor

Texas

  • Texas Children's Hospital - Houston

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2018-10-24
Est. Completion 2027-06
Phase Phase 3

Sponsor

Vericel Corporation

11 total trials

What the Registry Record Tells You About NCT03588975

The ClinicalTrials.gov registry entry for NCT03588975 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 290-participant average among 3 other Chondral Defect trials with a reported enrollment target (84% lower). The listed sponsor is Vericel Corporation, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Chondral Defect appearing as the primary indexed condition, and to 2 interventions - of which MACI is the first listed.

NCT03588975 reports 12 study locations spanning 8 distinct geographic areas - top geographies include California, Ohio, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03588975 about?

NCT03588975 is a clinical study titled "A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee". 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.

What is the current status of trial NCT03588975?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2018-10-24. Estimated completion is 2027-06.

What conditions does trial NCT03588975 study?

This clinical trial studies the following conditions: Chondral Defect, Articular Cartilage Defect, Osteochondritis Dissecans (OCD), Articular Cartilage Disorder of Knee.

What interventions are being tested in trial NCT03588975?

The interventions under investigation include: MACI (BIOLOGICAL), microfracture (PROCEDURE).

Who is sponsoring clinical trial NCT03588975?

This trial is sponsored by Vericel Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03588975 being conducted?

This trial has 12 study locations across California, Louisiana, Maryland, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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