muscletech2013solerorozco-131015074821-phpapp02.pdf

HOSPITAL CLNIC VETERINARI

RCT in stem cells From theory to prac4ce

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

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

Advanced Therapy

characterized

accurate dose

presentation

Medicines Agency control

phenotype

immunophenotype

plastic adherence

presentation

osteocito

condrocito

miocito

c. estroma

tenocito

adipocito

dexametasona indometacina

isobutilmetilxilina

dexametasona cido ascrbico

TGF-

MSC

in vitro

Osiris Therapeutics

glucocorticoides 5% suero equino

pluripotency

1 w 2 w 3 w

degeneration inflammation

regeneration fibrosis

muscle repair timing Time Factor

Dose Factor

BM or AT harvest

crio preserved intermediate product

therapeutic dose

Cell Therapy

cellular pre plating expantion cells

10 days

RICES

BM or AT allogenic

crio preserved intermediate product

therapeutic dose

Cell Therapy

cellular pre plating expantion cells

10 days

RICES

A

1 w 2 w 3 w

degeneration inflammation

regeneration fibrosis

muscle repair timing Time Factor

Dose Factor

osteocito

condrocito

miocito

c. estroma

tenocito

adipocito

MSC

in vitro

Osiris Therapeutics

BM-MSC 6 AT-MSC 6

SF

prp

12 equinos lesin SDTF 20x10E6 MSC

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

HOSPITAL CLNIC VETERINARI

RCT in stem cells From theory to prac4ce