Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with symptomatic chondral lesions of the knee
Exclusion Criteria
- •Inflammatory arthritis
- •Septic arthritis
- •Total meniscectomy
- •Previous microfracture at chondral lesions
- •Ochronosis
- •Acromegalia
Outcomes
Primary Outcomes
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
- Change of baseline to different periods in Clinical evaluation(0, 10, 30 days, 3, 6, 9, 12, 24, 36 months)
Investigators
Aldo Izaguirre
Study Director
Instituto Nacional de Rehabilitacion