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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: Recruiting Phase 3 study of Chondral Defect and Articular Cartilage Defect, sponsored by Vericel Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A responder is defined as a participant with ≥ 10-point change (improvement) in both the KOOS-Child Pain and Function (Sports and Recreational activities) scores from Baseline scores. The Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) is a validated knee-specific instrument developed to assess the participant's opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2027-06 |
| Phase | Phase 3 |
What NCT03588975 shows while recruiting
NCT03588975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 290-participant average among 3 other Chondral Defect trials with a reported enrollment target (84% lower).
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 lists 12 locations in 8 states (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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