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RecruitingNot ApplicableNCT04296487

Introduction of ACI for Cartilage Repair

Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee

Sponsor

Centre Hospitalier Universitaire Vaudois

Enrollment

218 participants

Start Date

Sep 1, 2017

Study Type

INTERVENTIONAL

Conditions

Chondral DefectArticular Cartilage DefectOsteochondritis

Summary

This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects.

Eligibility

Min Age: 15 YearsMax Age: 50 Years

Inclusion Criteria4

  • Age between 15 and 50.
  • Lesions classified as ICRS Grade III or IV and smaller than 15 cm2
  • Lesions that have failed prior therapy (conservative or surgical treatment ≥ six months)
  • Subjects who understand and sign the consent form for this study

Exclusion Criteria10

  • Body mass index (BMI) of 35 or more
  • Osteoarthritis or rheumatoid arthritis
  • Diffuse lesion
  • Uncorrected mal-alignment, ligamentous instability, or meniscal tear
  • Presence of growth cartilage (15-18 years old)
  • Active smoking or drug consumption
  • Women who are pregnant
  • Positive serology for HIV-1 or HIV-2, Hepatitis B and C and syphilis
  • Proven allergy to porcine collagen, penicillin and gentamicin
  • Poor compliance
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Interventions

OTHERautologous chondrocytes

autologous chondrocytes implantation (ACI)

Locations(1)

Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, Canton of Vaud, Switzerland

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NCT04296487

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