Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

• ClinicalTrials.gov Identifier: NCT01503970
• Recruitment Status: Completed
• First Posted: January 4, 2012
• Last Update Posted: April 12, 2017
• Sponsor: Instituto Nacional de Rehabilitacion
• Collaborator: National Council of Science and Technology, Mexico
• Information provided by (Responsible Party): Aldo Izaguirre, Instituto Nacional de Rehabilitacion

Study Description

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.

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

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 (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study
• Study Start Date: December 2008
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change of baseline to different periods in Clinical evaluation [ Time Frame: 0, 10, 30 days, 3, 6, 9, 12, 24, 36 months ]
   Clinical assessment with validated knee scores, and adverse effects register are taken.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes 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

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:

Masri M, Lombardero G, Velasquillo C, Martínez 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.

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

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.

• Responsible Party: Aldo Izaguirre, Study Director, Instituto Nacional de Rehabilitacion
• ClinicalTrials.gov Identifier: NCT01503970
• Other Study ID Numbers: 017-04-INR
• First Posted: January 4, 2012
• Last Update Posted: April 12, 2017
• Last Verified: April 2017

Keywords provided by Aldo Izaguirre, Instituto Nacional de Rehabilitacion:

chondral lesions; knee