Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration
| Tracking Information | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | December 1, 2011 | ||||||||||||||||
| Last Updated Date | January 5, 2012 | ||||||||||||||||
| Start Date ICMJE | December 2008 | ||||||||||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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. |
||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01503970 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration | ||||||||||||||||
| Official Title ICMJE | Autologous Chondrocyte Transplantation For Articular Cartilage Regeneration. Pilot Study | ||||||||||||||||
| 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. |
||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Phase 1 Phase 2 |
||||||||||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||||||||||
| Condition ICMJE | Tear; Knee, Cartilage, Articular | ||||||||||||||||
| Intervention ICMJE | 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. |
||||||||||||||||
| Study Arm (s) | Experimental: Chondrocyte implantation
Intervention: Device: Arthroscopic matrix encapsulated chondrocyte implantation |
||||||||||||||||
| Publications * |
|
||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||
| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||
| Enrollment ICMJE | 10 | ||||||||||||||||
| Estimated Completion Date | December 2012 | ||||||||||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||
| Gender | Male | ||||||||||||||||
| Ages | 18 Years to 50 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Mexico | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01503970 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 017-04-INR | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| Responsible Party | Aldo Izaguirre, Instituto Nacional de Rehabilitacion | ||||||||||||||||
| Study Sponsor ICMJE | Instituto Nacional de Rehabilitacion | ||||||||||||||||
| Collaborators ICMJE | National Council of Science and Technology, Mexico | ||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||
| Information Provided By | Instituto Nacional de Rehabilitacion | ||||||||||||||||
| Verification Date | January 2012 | ||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||