Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
January 4, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 12, 2017
April 1, 2017
3 years
December 1, 2011
April 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change of baseline to different periods in Clinical evaluation
0, 10, 30 days, 3, 6, 9, 12, 24, 36 months
Study Arms (1)
Chondrocyte implantation
EXPERIMENTALInterventions
Each implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect.
Eligibility Criteria
You may qualify if:
- Patients with symptomatic chondral lesions of the knee
You may not qualify if:
- Inflammatory arthritis
- Septic arthritis
- Total meniscectomy
- Previous microfracture at chondral lesions
- Paget
- Ochronosis
- Acromegalia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Rehabilitation Institute
Mexico City, 14389, Mexico
Related Publications (3)
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.
PMID: 17681210BACKGROUNDIbarra-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.
PMID: 19462773BACKGROUNDIbarra 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.
PMID: 24746406BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Director
Study Record Dates
First Submitted
December 1, 2011
First Posted
January 4, 2012
Study Start
December 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2012
Last Updated
April 12, 2017
Record last verified: 2017-04