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| Name | Class |
|---|---|
| National Council of Science and Technology, Mexico | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondrocyte implantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic matrix encapsulated chondrocyte implantation | Device | Each implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemente Ibarra, M.D. | INR | Principal Investigator |
| Luis Guillermo Ibarra, M.D. | INR | Study Chair |
| Aldo F Izaguirre, M.D. | INR | Study Director |
| Enrique Villalobos, M.D. | INR | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Rehabilitation Institute | Mexico City | 14389 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17681210 | Background | 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. | |
| 19462773 | Background |
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 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. |
| 24746406 | Background | 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. |