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

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ClinicalTrials.gov Identifier: NCT03588975
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Vericel Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Chondral Defect Osteochondritis Dissecans Articular Cartilage Defect Articular Cartilage Disorder of Knee Biological: MACI Procedure: microfracture Phase 3

Detailed Description:

This is a 2-year prospective, multicenter, randomized, open-label, parallel group clinical trial; a total of 45 patients, ages 10 to <17 years, will be randomized to receive a 1-time treatment with MACI or microfracture (2:1, 30 MACI:15 microfracture).

After meeting screening criteria at the initial visit, all patients will have a screening arthroscopy to further assess study eligibility. During the screening arthroscopy, patients will be further evaluated against entry criteria. Cartilage lesion size will be measured prior to any cartilage repair procedure and randomization. All patients who meet the eligibility criteria and are considered suitable for treatment in the study will have a cartilage biopsy taken prior to randomization to study treatment. Eligible patients will be randomized during the screening arthroscopy procedure to receive either MACI or microfracture treatment. Patients randomized to microfracture will undergo the procedure during the screening arthroscopy.

All biopsied tissue will be sent to the Vericel manufacturing facility in Cambridge, Massachusetts, where the sample will be processed to isolate the autologous chondrocytes. Cells from patients randomized to the MACI group will be used in the preparation of the MACI implant; cells from patients randomized to the microfracture group will be cryopreserved.

Patients randomized to treatment with MACI will return within 12 weeks of the screening arthroscopy to undergo the chondrocyte implantation procedure via arthrotomy. Patients are to follow a recommended postoperative rehabilitation program and compliance with the rehabilitation schedule will be monitored.

Patients will be followed post-study treatment for 2 years (104 Weeks).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients Aged 10 to < 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee Due to Osteochondritis Dissecans or Acute Trauma
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025


Arm Intervention/treatment
Experimental: MACI
autologous cultured chondrocytes on porcine collagen membrane
Biological: MACI
autologous cultured chondrocytes on porcine collagen membrane

Active Comparator: microfracture
surgical procedure
Procedure: microfracture
Arthroscopic microfracture treatment




Primary Outcome Measures :
  1. Proportion of Patients Who Achieve at Least a 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Scores [ Time Frame: Baseline and Week 104 ]
    A responder is defined as a participant with at least a 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 patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL).


Secondary Outcome Measures :
  1. Change from Baseline in KOOS-Child subscores [ Time Frame: Baseline and Week 104 ]
    The Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL).

  2. Change from Baseline in KOOS-Child subscores [ Time Frame: Baseline and Week 52 ]
    The Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL).


Other Outcome Measures:
  1. Treatment Emergent Adverse Events [ Time Frame: Week 104 ]
    A treatment emergent untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic cartilage or osteochondral defects as a result of acute trauma or Osteochondritis Dissecans (OCD)
  • One or more International Cartilage Repair Society (ICRS) Grade III or IV chondral or unsalvageable osteochondral defects located on the femoral condyles and/or trochlea amenable to treatment with the surgical procedure determined at randomization (MACI or microfracture).
  • At least 1 defect size ≥2.0 cm2 on the femoral condyles and/or the trochlea; defects include OCD lesions with a bone lesion depth of ≤6 mm and does not require a bone graft.
  • Stable target knee (ie, anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact). Ligament repair or reconstruction procedures are allowed prior to screening arthroscopy.
  • Intact meniscus or partial meniscus (at least 50% of functional meniscus remaining) in the target knee.

Exclusion Criteria:

  • Any surgery on the target knee joint within 6 months prior to Screening (not including diagnostic arthroscopy)
  • ICRS Grade III or IV chondral or unsalvageable osteochondral defects located on the patella or tibia or any lesion that is bipolar to the index lesion
  • Concomitant inflammatory disease or other conditions that affects the joints (eg,rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis)
  • Known history of septic arthritis in the index knee joint
  • Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
  • Females who are pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588975


Contacts
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Contact: Ann E Remmers, PhD 7202739484 aremmers@vcel.com
Contact: Daria Wicks dwicks@vcel.com

Locations
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United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Shriner's Hospital for Children Northern California Recruiting
Sacramento, California, United States, 95817
United States, Louisiana
Ochsner Sports Medicine Institute Recruiting
New Orleans, Louisiana, United States, 70121
United States, Maryland
Johns Hopkins Outpatient Center Not yet recruiting
Baltimore, Maryland, United States, 21224
United States, Minnesota
TRIA Orthopaedic Center Recruiting
Bloomington, Minnesota, United States, 55431
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10467
United States, Ohio
The Ohio State University Jameson Crane Sports Medicine Institute Recruiting
Columbus, Ohio, United States, 43202
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Penn Sports Medicine Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Children's Health Andrews Institute for Othopedics & Sports Medicine Recruiting
Plano, Texas, United States, 75024
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Vericel Corporation

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Responsible Party: Vericel Corporation
ClinicalTrials.gov Identifier: NCT03588975     History of Changes
Other Study ID Numbers: 55-1702-1
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cartilage Diseases
Osteochondritis
Osteochondritis Dissecans
Musculoskeletal Diseases
Connective Tissue Diseases
Bone Diseases