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Clinical Trials/NCT01503970
NCT01503970
Completed
Phase 1

Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study

Instituto Nacional de Rehabilitacion1 site in 1 country10 target enrollmentDecember 2008

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Tear; Knee, Cartilage, Articular
Sponsor
Instituto Nacional de Rehabilitacion
Enrollment
10
Locations
1
Primary Endpoint
Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment.
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
December 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aldo Izaguirre

Study Director

Instituto Nacional de Rehabilitacion

Eligibility Criteria

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)

Study Sites (1)

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