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RCT

in stem cells

From theory to prac4ce


HOSPITAL CLNIC VETERINARI

Equine CARTILAGE

animal model

Ovine CARTILAGE
Ovine P. NERVE
Equine tendon

BONE

Maxilar

Aastrom

Pseudoarthrosis Aastrom

BST

Pseudoarthrosis Aastrom

BST

Osteonecrosis

clinical trials

BST

BST

Aastrom

Pseudoarthrosis Salvat - Histocell

DISC

CARTILAGE

IBGM

PEi 10-134
OA II-III

BST

OA II-IV

IBGM

OA II-IV crio

MSC RESEARCH 2013

PEi 10-005

IBGM

OA II-IV alo vs hialur.


OA II-IV (MSC vs PRP)

PEi 05-048

IBGM

PEi

EMA

Ensayo clnico III Uso Compasivo

Procedimiento
Centralizado

Clusula
Exclusin

Ensayo clnico I-II

PEi
RD 1301/2006 RD1825/2009

OCATT

ONT

Hospital
RD 2043/94
RD 1369/2000

preclnica BPL

AEMPS

CEICs
Gestora

CRO
protocolo

inves4gadores
Financiacin

RD 223/2004
Ley 29/2006
RD 1344/2007
Ley 14/2007

Laboratorio GMP
Promotor

Advanced Therapy
characterized
accurate dose
presentation
Medicines Agency control

phenotype
immunophenotype

plastic adherence
presentation

pluripotency
ro
t
i
v
in

MS
C
dexametasona
TGF-
glucocorticoides
indometacina
cido
ascrbico
5%
suero
equino
isobutilmetilxilina

osteocito
condrocito
miocito
c. estroma
tenocito
adipocito
Osiris Therapeutics

muscle repair timing


inflammation
degeneration regeneration

1w

2w

Time Factor
fibrosis

3w
Dose Factor

RICES

Cell
Therapy
therapeutic
dose

BM or AT harvest
10 days

cellular pre plating


crio preserved
intermediate product

expantion cells

RICES

Cell
Therapy
therapeutic
dose

BM or AT allogenic
10 days

cellular pre plating


crio preserved
intermediate product

expantion cells

muscle repair timing


inflammation
degeneration regeneration

1w

2w

Time Factor
fibrosis

3w
Dose Factor

o
r
t
i
in v

MS
C

osteocito
condrocito
miocito
c. estroma
tenocito
adipocito
Osiris Therapeutics

12 equinos
lesin SDTF
20x10E6 MSC

BM-MSC 6
AT-MSC 6
SF

prp

manguito rotadores
20x10E6 MSC + membrana
Hospital Universitario San Carlos. Madrid

epicondilitis
1x10E6 vs 10x10E6 allo-AT MSC

Conclusiones
Terapia celular con MSC
(dosis: 15x10E6 a 40x10E6)

Viable
Segura
Indicios de eficacia
Actual: Solo bajo ensayo o UC
Control Agencia Medicamento


RCT in stem cells

From theory to prac4ce


HOSPITAL CLNIC VETERINARI

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