Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Instituto Nacional de Rehabilitacion.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Aldo Izaguirre, Instituto Nacional de Rehabilitacion
ClinicalTrials.gov Identifier:
NCT01503970
First received: December 1, 2011
Last updated: January 5, 2012
Last verified: January 2012

December 1, 2011
January 5, 2012
December 2008
December 2011   (final data collection date for primary outcome measure)
Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment. [ Time Frame: 3, 6, 9, 12, 18, 24 36 months ] [ Designated as safety issue: Yes ]
Special magnetic resonance imaging technique for measurement of collagen and water content, it is expressed in milliseconds.
Same as current
Complete list of historical versions of study NCT01503970 on ClinicalTrials.gov Archive Site
Change of baseline to different periods in Clinical evaluation [ Time Frame: 0, 10, 30 days, 3, 6, 9, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
Clinical assessment with validated knee scores, and adverse effects register are taken.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tear; Knee, Cartilage, Articular
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.
Experimental: Chondrocyte implantation
Intervention: Device: Arthroscopic matrix encapsulated chondrocyte implantation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01503970
017-04-INR
Yes
Aldo Izaguirre, Instituto Nacional de Rehabilitacion
Instituto Nacional de Rehabilitacion
National Council of Science and Technology, Mexico
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
Instituto Nacional de Rehabilitacion
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP