Extension Study for Participants of MACI00206 Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Knee
NCT ID: NCT01251588
Last Updated: 2021-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
128 participants
OBSERVATIONAL
2010-12-31
2015-03-31
Brief Summary
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Detailed Description
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All 144 participants who received study treatment in the SUMMIT study were eligible for enrollment into this extension study. Participants had until the end of the visit window for the last visit of this extension study (ie, Week 260 + 6 weeks) to consent to enter this extension study.
Efficacy and safety assessments were performed at scheduled visits 3, 4, and 5 years following treatment in SUMMIT (ie, at Weeks 156, 208, and 260 postarthrotomy for patients treated with MACI implant or at Weeks 156, 208, and 260 postarthroscopy for patients treated with microfracture).
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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MACI
autologous cultured chondrocytes on porcine collagen membrane implant received in previous MACI00206 study
autologous cultured chondrocytes on porcine collagen membrane
Implantation received in the previous MACI00206 study
Microfracture
Microfracture treatment received in previous MACI00206 study
Microfracture
Arthroscopic Microfracture treatment received in the previous MACI00206 study
Interventions
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autologous cultured chondrocytes on porcine collagen membrane
Implantation received in the previous MACI00206 study
Microfracture
Arthroscopic Microfracture treatment received in the previous MACI00206 study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
55 Years
ALL
No
Sponsors
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Vericel Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Urazova nemocnice v Brne
Brno, , Czechia
University Hospital Na Bulovce- Department of Orthopaedic Surgery Postgraduate Medical Institute
Prague, , Czechia
Polyclinique Saint-Roch
Montpellier, , France
Clinique Maussins-Nollet
Paris, , France
Hôpital d'instruction des Armées Robert Picqué
Villenave-d'Ornon, , France
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
St. Elisabeth Ziekenhuis
Tilburg, , Netherlands
University Medical Centre of Utrecht, Department of Orthopaedics
Utrecht, , Netherlands
St Olavs Hospital
Trondheim, , Norway
Orthopaedic & Traumatology of Motor Organs, Independent Public Clinic Hospital
Bydgoszcz, , Poland
Regional Centre of Knee Surgery & Arthroscopy, Regional Hospital of Traumatologic Surgery
Piekary Śląskie, , Poland
Lekmed Medical Center
Warszewo, , Poland
Kungsbacka Närsjukhus
Kungsbacka, , Sweden
University of Oxford, Nuffield Dept. of Orthopaedic Surgery
Oxford, , United Kingdom
Countries
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Other Identifiers
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2009-016970-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MACI00809
Identifier Type: -
Identifier Source: org_study_id
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