Robert Soler and Lluis Orozco. Regenerative Tissue Therapy Institute at the Teknon Medical Centre (ITRT), Barcelona, Spain.
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RCT in stem cells. From theory to practice
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Robert Soler and Lluis Orozco. Regenerative Tissue Therapy Institute at the Teknon Medical Centre (ITRT), Barcelona, Spain.
- 1. RCT in stem cells From theory to prac4ce HOSPITAL CLÍNIC VETERINARI
- 2. Equine CARTILAGE animal model Ovine CARTILAGE Ovine P. NERVE Equine tendon Maxilar Aastrom BST Pseudoarthrosis Aastrom BONE BST Pseudoarthrosis Aastrom BST Osteonecrosis clinical trials BST Aastrom Pseudoarthrosis Salvat - Histocell DISC IBGM PEi 10-134 OA II-‐III° OA II-‐IV° CARTILAGE BST IBGM OA II-‐IV° alo vs hialur. MSC RESEARCH 2013 PEi 10-005 IBGM OA II-‐IV° crio OA II-‐IV° (MSC vs PRP) PEi 05-048 IBGM PEi
- 3. EMA Ensayo clínico III Uso Compasivo Procedimiento Centralizado Cláusula Exclusión Ensayo clínico I-‐II PEi RD 1301/2006 RD1825/2009 OCATT ONT Hospital RD 2043/94 RD 1369/2000 preclínica BPL AEMPS CEICs Gestora CRO protocolo inves4gadores Financiación RD 223/2004 Ley 29/2006 RD 1344/2007 Ley 14/2007 Laboratorio GMP Promotor
- 4. Advanced Therapy characterized accurate dose presentation Medicines Agency control
- 6. pluripotency vitro in MS C dexametasona TGF-β glucocorticoides indometacina ácido ascórbico 5% suero equino isobutilmetilxilina osteocito condrocito miocito c. estroma tenocito adipocito • Osiris Therapeutics
- 8. muscle repair timing inflammation degeneration regeneration 1w 2w Time Factor fibrosis 3w Dose Factor
- 9. RICES Cell Therapy therapeutic dose BM or AT harvest 10 days cellular pre plating crio preserved intermediate product expantion cells
- 10. RICES A Cell Therapy therapeutic dose BM or AT allogenic 10 days cellular pre plating crio preserved intermediate product expantion cells
- 11. muscle repair timing inflammation degeneration regeneration 1w 2w Time Factor fibrosis 3w Dose Factor
- 12. itro in v MS C osteocito condrocito miocito c. estroma tenocito adipocito • Osiris Therapeutics
- 13. 12 equinos lesión SDTF 20x10E6 MSC BM-‐MSC 6 AT-‐MSC 6 SF prp
- 14. manguito rotadores 20x10E6 MSC + membrana Hospital Universitario San Carlos. Madrid epicondilitis 1x10E6 vs 10x10E6 allo-AT MSC
- 15. Conclusiones Terapia celular con MSC (dosis: 15x10E6 a 40x10E6) § Viable § Segura § Indicios de eficacia § Actual: Solo bajo ensayo o UC § Control Agencia Medicamento
- 16. RCT in stem cells From theory to prac4ce HOSPITAL CLÍNIC VETERINARI