Clinical Trials Directory

Trials / Completed

CompletedNCT01503970

Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Instituto Nacional de Rehabilitacion · Other Government
Sex
Male
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEArthroscopic matrix encapsulated chondrocyte implantationEach implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect.

Timeline

Start date
2008-12-01
Primary completion
2011-12-01
Completion
2012-12-01
First posted
2012-01-04
Last updated
2017-04-12

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT01503970. Inclusion in this directory is not an endorsement.