Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

NCT ID: NCT01503970

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-12-31

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.

Conditions

Tear; Knee, Cartilage, Articular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chondrocyte implantation

Group Type: EXPERIMENTAL

Arthroscopic matrix encapsulated chondrocyte implantation

Intervention Type: DEVICE

Each implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect.

Interventions

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.

Intervention Type: DEVICE

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
• Paget
• Ochronosis
• Acromegalia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

Instituto Nacional de Rehabilitacion

OTHER_GOV

Sponsor Role: lead

Responsible Party

Aldo Izaguirre

Study Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clemente Ibarra, M.D.

Role: PRINCIPAL_INVESTIGATOR

INR

Luis Guillermo Ibarra, M.D.

Role: STUDY_CHAIR

INR

Aldo F Izaguirre, M.D.

Role: STUDY_DIRECTOR

INR

Enrique Villalobos, M.D.

Role: STUDY_DIRECTOR

INR

Locations

National Rehabilitation Institute

Mexico City, , Mexico

Countries

Mexico

References

Masri M, Lombardero G, Velasquillo C, Martinez V, Neri R, Villegas H, Ibarra C. Matrix-encapsulation cell-seeding technique to prevent cell detachment during arthroscopic implantation of matrix-induced autologous chondrocytes. Arthroscopy. 2007 Aug;23(8):877-83. doi: 10.1016/j.arthro.2007.05.010.

Reference Type: BACKGROUND

PMID: 17681210 (View on PubMed)

Ibarra-Ponce de Leon JC, Velasquillo-Martinez MC, Izaguirre A, Villalobos-Cordova E, Masri M, Ibarra-Ibarra LG. [Cartilage repair: cell-based techniques]. Acta Ortop Mex. 2009 Jan-Feb;23(1):38-44. Spanish.

Reference Type: BACKGROUND

PMID: 19462773 (View on PubMed)

Ibarra C, Izaguirre A, Villalobos E, Masri M, Lombardero G, Martinez V, Velasquillo C, Meza AO, Guevara V, Ibarra LG. Follow-up of a new arthroscopic technique for implantation of matrix-encapsulated autologous chondrocytes in the knee. Arthroscopy. 2014 Jun;30(6):715-23. doi: 10.1016/j.arthro.2014.02.032. Epub 2014 Apr 18.

Reference Type: BACKGROUND

PMID: 24746406 (View on PubMed)

Other Identifiers

017-04-INR

Identifier Type: -

Identifier Source: org_study_id