Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

Tear; Knee, Cartilage, Articular Clinical Trial

Official title:

Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503970
• Other study ID #: 017-04-INR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 1, 2011
• Last updated: April 11, 2017
• Start date: December 2008
• Est. completion date: December 2012

Study information

• Verified date: April 2017
• Source: Instituto Nacional de Rehabilitacion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Tear; Knee, Cartilage, Articular

Intervention

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.

Locations

Country	Name	City	State
Mexico	National Rehabilitation Institute	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Rehabilitacion	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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