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
| Type | Name | Description |
|---|---|---|
| DEVICE | Arthroscopic matrix encapsulated chondrocyte implantation | Each 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.