robert soler and lluis orozco. regenerative tissue therapy institute at the teknon medical centre...
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RCT in stem cells. From theory to practiceTRANSCRIPT
![Page 1: Robert Soler and Lluis Orozco. Regenerative Tissue Therapy Institute at the Teknon Medical Centre (ITRT), Barcelona, Spain](https://reader034.vdocuments.site/reader034/viewer/2022042713/549a652fb479596c668b456b/html5/thumbnails/1.jpg)
HOSPITAL CLÍNIC VETERINARI
RCT in stem cells From theory to prac4ce
![Page 2: Robert Soler and Lluis Orozco. Regenerative Tissue Therapy Institute at the Teknon Medical Centre (ITRT), Barcelona, Spain](https://reader034.vdocuments.site/reader034/viewer/2022042713/549a652fb479596c668b456b/html5/thumbnails/2.jpg)
MSC RESEARCH 2013
DISC
Ovine P. NERVE
Aastrom
IBGM
Ovine CARTILAGE
Pseudoarthrosis
Osteonecrosis
Maxilar
Equine CARTILAGE
Pseudoarthrosis clinical trials
Pseudoarthrosis PEi
PEi Salvat - Histocell
Aastrom
Aastrom
Aastrom
BONE 05-048
BST
BST
BST
BST
PEi 10-134
OA II-‐III°
OA II-‐IV°
BST PEi
OA II-‐IV° crio
OA II-‐IV° alo vs hialur.
IBGM
IBGM
IBGM
10-005
OA II-‐IV° (MSC vs PRP)
CARTILAGE
animal model
Equine tendon
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Ensayo clínico I-‐II
ONT
preclínica BPL
Procedimiento Centralizado
Cláusula Exclusión
Ensayo clínico III
OCATT AEMPS
protocolo
CEICs
Laboratorio GMP
Hospital
PEi
CRO
Promotor
inves4gadores RD 2043/94
RD 1369/2000
Gestora
Uso Compasivo EMA
Financiación
RD 223/2004 Ley 29/2006
RD 1344/2007
Ley 14/2007
RD1825/2009 RD 1301/2006
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Advanced Therapy
characterized
accurate dose
presentation
Medicines Agency control
![Page 5: Robert Soler and Lluis Orozco. Regenerative Tissue Therapy Institute at the Teknon Medical Centre (ITRT), Barcelona, Spain](https://reader034.vdocuments.site/reader034/viewer/2022042713/549a652fb479596c668b456b/html5/thumbnails/5.jpg)
phenotype
immunophenotype
plastic adherence
presentation
![Page 6: Robert Soler and Lluis Orozco. Regenerative Tissue Therapy Institute at the Teknon Medical Centre (ITRT), Barcelona, Spain](https://reader034.vdocuments.site/reader034/viewer/2022042713/549a652fb479596c668b456b/html5/thumbnails/6.jpg)
osteocito
condrocito
miocito
c. estroma
tenocito
adipocito
dexametasona indometacina
isobutilmetilxilina
dexametasona ácido ascórbico
TGF-β
MSC
in vitro
• Osiris Therapeutics
glucocorticoides 5% suero equino
pluripotency
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![Page 8: Robert Soler and Lluis Orozco. Regenerative Tissue Therapy Institute at the Teknon Medical Centre (ITRT), Barcelona, Spain](https://reader034.vdocuments.site/reader034/viewer/2022042713/549a652fb479596c668b456b/html5/thumbnails/8.jpg)
1 w 2 w 3 w
degeneration inflammation
regeneration fibrosis
muscle repair timing Time Factor
Dose Factor
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BM or AT harvest
crio preserved intermediate product
therapeutic dose
Cell Therapy
cellular pre plating expantion cells
10 days
RICES
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BM or AT allogenic
crio preserved intermediate product
therapeutic dose
Cell Therapy
cellular pre plating expantion cells
10 days
RICES
A
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1 w 2 w 3 w
degeneration inflammation
regeneration fibrosis
muscle repair timing Time Factor
Dose Factor
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osteocito
condrocito
miocito
c. estroma
tenocito
adipocito
MSC
in vitro
• Osiris Therapeutics
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BM-‐MSC 6 AT-‐MSC 6
SF
prp
12 equinos lesión SDTF 20x10E6 MSC
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manguito rotadores 20x10E6 MSC + membrana Hospital Universitario San Carlos. Madrid
epicondilitis 1x10E6 vs 10x10E6 allo-AT MSC
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Conclusiones
Terapia celular con MSC (dosis: 15x10E6 a 40x10E6)
§ Viable § Segura § Indicios de eficacia § Actual: Solo bajo ensayo o UC § Control Agencia Medicamento
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HOSPITAL CLÍNIC VETERINARI
RCT in stem cells From theory to prac4ce