[Perspectives of clinical stem cell therapy in the treatment of musculoskeletal diseases in Germany].
OBJECTIVE
The treatment of large bone defects remains a challenge for the orthopaedic surgeon. Regenerative therapies with the use of mesenchymal stem cells (MSC) may provide an alternative to autogenous bone transplantation, callus distraction or the use of allografts.


METHODS
On the occasion of an expert workshop of the German Society for Orthopaedic and Trauma Surgery, a literature search regarding studies with the use of MSC was performed to evaluate its potential for future clinical studies. Furthermore, the legislative requirements were examined.


RESULTS
Various in vitro and animal studies showed the benefit of MSC in bone regeneration. However, there are sparse data from clinical studies. Due to recent legislative changes there are several regulatory demands to meet if clinical studies are performed with MSC.


CONCLUSIONS
For further evaluation of the role of MSC in the treatment of bone defects there is a need for clinical trials. The current paper provides some assistance for the successful application for clinical trials with MSC. Planning and performance of these studies may require early consultation with the regulatory authorities and cooperation of research centres in order to obtain authorisation for the evaluation of MSC. Preclinical data have to be obtained according to good laboratory practice with equivalent protocols that will be used in the clinical trials. In the latter the implementation of the guidelines for good clinical practice are mandatory.
Kasten
P
P
Klinik und Poliklinik für Orthopädie, Universitätsklinikum Carl Gustav Carus Dresden, Dresden.
Bernstein
P
P
Biewener
A
A
Bornhäuser
M
M
Duda
G
G
Gaissmaier
C
C
Nöth
U
U
Pfüller
B
B
Reinhardt
J
J
Zwipp
H
H
Günther
K P
KP
D000818:Animals; D001861:Bone Regeneration / Q000502:physiology; D016025:Bone Transplantation / Q000331:legislation & jurisprudence; D001842:Bone and Bones / Q000601:surgery*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003299:Cooperative Behavior; D004195:Disease Models, Animal; D004493:Education; D005858:Germany; D006801:Humans; D033183:Interdisciplinary Communication; D045164:Mesenchymal Stem Cell Transplantation / Q000331:legislation & jurisprudence*; D009313:National Health Programs / Q000331:legislation & jurisprudence; D019637:Orthopedic Procedures / Q000331:legislation & jurisprudence*; D019857:Osteogenesis, Distraction / Q000331:legislation & jurisprudence / Q000379:methods