Clinical trial NCT01503970: Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration
Official title: Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tear; Knee, Cartilage, Articular
Keywords: chondral lesions
knee
Lead sponsor: Instituto Nacional de Rehabilitacion
Sponsor class: OTHER_GOV
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2012-01-04
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment.
timeFrame: 3, 6, 9, 12, 18, 24 36 months
Secondary outcomes:
measure: Change of baseline to different periods in Clinical evaluation
timeFrame: 0, 10, 30 days, 3, 6, 9, 12, 24, 36 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Rehabilitation Institute
Study officials:
affiliation: INR
name: Clemente Ibarra, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: INR
name: Luis Guillermo Ibarra, M.D.
role: STUDY_CHAIR
affiliation: INR
name: Aldo F Izaguirre, M.D.
role: STUDY_DIRECTOR
affiliation: INR
name: Enrique Villalobos, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.