Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Instituto Nacional de Rehabilitacion.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Aldo Izaguirre, Instituto Nacional de Rehabilitacion
ClinicalTrials.gov Identifier:
NCT01503970
First received: December 1, 2011
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Tear; Knee, Cartilage, Articular
Device: Arthroscopic matrix encapsulated chondrocyte implantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study

Further study details as provided by Instituto Nacional de Rehabilitacion:

Primary Outcome Measures:
  • Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment. [ Time Frame: 3, 6, 9, 12, 18, 24 36 months ] [ Designated as safety issue: Yes ]
    Special magnetic resonance imaging technique for measurement of collagen and water content, it is expressed in milliseconds.


Secondary Outcome Measures:
  • Change of baseline to different periods in Clinical evaluation [ Time Frame: 0, 10, 30 days, 3, 6, 9, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
    Clinical assessment with validated knee scores, and adverse effects register are taken.


Enrollment: 10
Study Start Date: December 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chondrocyte implantation 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503970

Locations
Mexico
National Rehabilitation Institute
Mexico City, Mexico, 14389
Sponsors and Collaborators
Instituto Nacional de Rehabilitacion
National Council of Science and Technology, Mexico
Investigators
Principal Investigator: Clemente Ibarra, M.D. INR
Study Chair: Luis Guillermo Ibarra, M.D. INR
Study Director: Aldo F Izaguirre, M.D. INR
Study Director: Enrique Villalobos, M.D. INR
  More Information

Publications:
Responsible Party: Aldo Izaguirre, Study Director, Instituto Nacional de Rehabilitacion
ClinicalTrials.gov Identifier: NCT01503970     History of Changes
Other Study ID Numbers: 017-04-INR
Study First Received: December 1, 2011
Last Updated: January 5, 2012
Health Authority: Mexico: National Council of Science and Technology

Keywords provided by Instituto Nacional de Rehabilitacion:
chondral lesions
knee

ClinicalTrials.gov processed this record on April 17, 2014