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| Name | Class |
|---|---|
| Centro Medico Teknon | OTHER |
| Institut de Terapia Regenerativa Tissular | OTHER |
| Cetir Sant Jordi, S.a.. | INDIV |
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This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary objectives are to assess the efficacy by imaging procedures and clinical questionnaires.
MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36) at 3, 6 and 12 month.
The working hypothesis proposes that the expected regenerative articular cartilage effect of the MSC will be produced to a measurable degree by imaging procedures and clinical questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous MSC knee implantation | Experimental | Isolation and "Ex-Vivo" expansion of Mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia-División de Terapias Avanzadas del Banc de Sang I Teixits. After 21 days, approximately 40 millions of autologous MSC will be implanted in the knee by articular injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous MSC knee implantation | Other | Isolation and "Ex-Vivo" expansion of Mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, approximately 40 millions of autologous MSC will be implanted in the knee by articular injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration. | Feasibility will be assessed by checking the cascade of procedures (from bone marrow extraction to MSC implantation) and confirming the global process is viable. | 12 months |
| Safety of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration. | Safety will be assessed by collecting adverse events throughout the experimental phase, including the follow-up at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy by imaging procedures. | Articular cartilage changes will be determined by T2-weighted MRI (Cartigram). | 6 months |
| Efficacy by imaging procedures. | Articular cartilage changes will be determined by T2-weighted MRI (Cartigram). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Soler, MD | Institut de Terà pia Regenerativa Tissular (ITRT) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Medico Teknon-ITRT | Barcelona | 08022 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25769789 | Derived | Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10. |
| Label | URL |
|---|---|
| Institut de Terapia Regenerativa Tissular (ITRT), Barcelona, Spain | View source |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007718 | Knee Injuries |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
| D002357 | Cartilage Diseases |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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|
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| 12 month |
| Clinical outcomes. | Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36). | 3 month |
| Clinical outcomes. | Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36). | 6 months |
| Clinical outcomes. | Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36). | 12 months |
| Banc de Sang i Teixits | View source |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |