Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

Phase 1

Completed

• Conditions: Tear; Knee, Cartilage, Articular
• Interventions: Device: Arthroscopic matrix encapsulated chondrocyte implantation

• Registration Number: NCT01503970
• Lead Sponsor: Instituto Nacional de Rehabilitacion

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2011-12
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2012-01-02
• Study First Posted: 2012-01-04
• Study Completion: 2012-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chondrocyte implantation	Arthroscopic matrix encapsulated chondrocyte implantation	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment.	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 Outcome Measures

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

Trial Locations

Locations (1)

National Rehabilitation Institute; 🇲🇽 Mexico City, Mexico