muscletech2013solerorozco-131015074821-phpapp02.pdf
TRANSCRIPT
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HOSPITAL CLNIC VETERINARI
RCT in stem cells From theory to prac4ce
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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 clnico I-II
ONT
preclnica BPL
Procedimiento Centralizado
Clusula Exclusin
Ensayo clnico III
OCATT AEMPS
protocolo
CEICs
Laboratorio GMP
Hospital
PEi
CRO
Promotor
inves4gadores RD 2043/94
RD 1369/2000
Gestora
Uso Compasivo EMA
Financiacin
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
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phenotype
immunophenotype
plastic adherence
presentation
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osteocito
condrocito
miocito
c. estroma
tenocito
adipocito
dexametasona indometacina
isobutilmetilxilina
dexametasona cido ascrbico
TGF-
MSC
in vitro
Osiris Therapeutics
glucocorticoides 5% suero equino
pluripotency
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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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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 lesin 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 CLNIC VETERINARI
RCT in stem cells From theory to prac4ce