Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Tear; Knee, Cartilage, Articular
• Intervention / Treatment: Device: Arthroscopic matrix encapsulated chondrocyte implantation

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14389
    • National Rehabilitation Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment.	Special magnetic resonance imaging technique for measurement of collagen and water content, it is expressed in milliseconds.	3, 6, 9, 12, 18, 24 36 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Rehabilitacion
• Collaborators: National Council of Science and Technology, Mexico
• Investigators: Study Chair: Luis Guillermo Ibarra, M.D., INR; Study Director: Aldo F Izaguirre, M.D., INR

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: January 2, 2012
• First Posted (Estimate): January 4, 2012

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: knee; chondral lesions
• Other Study ID Numbers: 017-04-INR