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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Vericel Corporation
Study ID
NCT03588975
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • MACI — BIOLOGICAL
    autologous cultured chondrocytes on porcine collagen membrane
  • microfracture — PROCEDURE
    Arthroscopic microfracture treatment

Study Details

The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of participants aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.

Key Dates

First listed
Jul 17, 2018
Start date
Oct 24, 2018
Status verified
Jun 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MACI
    autologous cultured chondrocytes on porcine collagen membrane
  • Other: microfracture
    surgical procedure

Primary Outcome Measure

Proportion of Participants Who Achieve ≥ 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Subscale Scores [ Time Frame: Baseline and Week 104 ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304-
Shriner's Hospital for Children Northern CaliforniaSacramentoCalifornia95817-
University of California Davis HealthSacramentoCalifornia95817-
Ochsner Sports Medicine InstituteNew OrleansLouisiana70121-
Johns Hopkins Outpatient CenterBaltimoreMaryland21224-
University of MichiganAnn ArborMichigan48106-
Akron Children's HospitalAkronOhio44308-
The Ohio State University Jameson Crane Sports Medicine InstituteColumbusOhio43202-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Penn Sports Medicine CenterPhiladelphiaPennsylvania19104-
Texas Children's HospitalHoustonTexas77094-
Medical College of WisconsinMilwaukeeWisconsin53201-

Find similar trials in Palo Alto, CA

By research site
Stanford University· Palo Alto, CAShriner's Hospital for Children Northern California· Sacramento, CAUniversity of California Davis Health· Sacramento, CAOchsner Sports Medicine Institute· New Orleans, LAJohns Hopkins Outpatient Center· Baltimore, MDUniversity of Michigan· Ann Arbor, MI

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