Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study

Conditions
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Tear; Knee, Cartilage, Articular

Intervention / Treatment
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* Device: Arthroscopic matrix encapsulated chondrocyte implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chondrocyte implantation<br> | Device: Arthroscopic matrix encapsulated chondrocyte implantation<br>* Each implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment. | Special magnetic resonance imaging technique for measurement of collagen and water content, it is expressed in milliseconds. | 3, 6, 9, 12, 18, 24 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of baseline to different periods in Clinical evaluation | Clinical assessment with validated knee scores, and adverse effects register are taken. | 0, 10, 30 days, 3, 6, 9, 12, 24, 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, chondral lesions