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Completed

NCT Number: NCT01503970

Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

The purpose of this study is to assess safety and efficacy of autologous chondrocyte implantation delivered arthroscopically into chondral lesions of the knee using clinical, biochemical, and MRI outcomes.

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Key information

Conditions

Tear; Knee, Cartilage, Articular Lacerations Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Rehabilitation Institute

Mexico City, 14389, Mexico

About this study

Injuries to the articular cartilage of the knee are common. They produce pain and deteriotation of patients' quality of life. The management of focal chondral lesions continues to be problematic for the treating orthopaedic surgeon. Although many treatment options are currently available, none fulfill the criteria for an ideal repair solution: a hyaline repair tissue that completely fills the defect and integrates well with the surrounding normal cartilage. Autologous chondrocyte implantation is a relatively new cell-based treatment method for full-thickness cartilage injuries that in recent years has increased in popularity, with different studies showing promising results. Typically, this implantation is performed in an open-surgery fashion. In our study the implantation of in-house autologous chondrocyte culture is done arthroscopically, situation that may offer advantages in surgery associated morbidity and patient recovery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with symptomatic chondral lesions of the knee

Exclusion criteria

  • Inflammatory arthritis
  • Septic arthritis
  • Total meniscectomy
  • Previous microfracture at chondral lesions
  • Paget
  • Ochronosis
  • Acromegalia

Treatment and study plan

Arthroscopic matrix encapsulated chondrocyte implantation

Device

Each implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect.

Primary outcomes

  1. Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment.

    Time frame: 3, 6, 9, 12, 18, 24 36 months

    Special magnetic resonance imaging technique for measurement of collagen and water content, it is expressed in milliseconds.

Secondary outcomes

  1. Change of baseline to different periods in Clinical evaluation

    Time frame: 0, 10, 30 days, 3, 6, 9, 12, 24, 36 months

    Clinical assessment with validated knee scores, and adverse effects register are taken.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Rehabilitacion

Other Gov

Collaborators

  • National Council of Science and Technology, Mexico

Registry information

Official study title

Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jan 4, 2012
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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