HIPGEN: a randomized, multicentre phase III study using intramuscular PLacenta-eXpanded stromal cells therapy for recovery following hip fracture arthroplasty : a study design.
Allogeneic cell therapy
Cell therapy
Femoral neck fracture
Hip fracture
Hip fractures
Lower Extremities
PLX-PAD
arthroplasty
cell-based therapy
femoral neck fractures
hip arthroplasty
intramuscular injections
muscle injuries
strength
stromal cells
Journal
Bone & joint open
ISSN: 2633-1462
Titre abrégé: Bone Jt Open
Pays: England
ID NLM: 101770336
Informations de publication
Date de publication:
04 2022
04 2022
Historique:
entrez:
22
4
2022
pubmed:
23
4
2022
medline:
23
4
2022
Statut:
ppublish
Résumé
The aim of the HIPGEN consortium is to develop the first cell therapy product for hip fracture patients using PLacental-eXpanded (PLX-PAD) stromal cells. HIPGEN is a multicentre, multinational, randomized, double-blind, placebo-controlled trial. A total of 240 patients aged 60 to 90 years with low-energy femoral neck fractures (FNF) will be allocated to two arms and receive an intramuscular injection of either 150 × 10 The HIPGEN study assesses the efficacy, safety, and tolerability of intramuscular PLX-PAD administration for the treatment of muscle injury following arthroplasty for hip fracture. It is the first phase III study to investigate the effect of an allogeneic cell therapy on improved mobilization after hip fracture, an aspect which is in sore need of addressing for the improvement in standard of care treatment for patients with FNF. Cite this article:
Identifiants
pubmed: 35451865
doi: 10.1302/2633-1462.34.BJO-2021-0156.R1
pmc: PMC9044085
doi:
Types de publication
Journal Article
Langues
eng
Pagination
340-347Investigateurs
Alison Agres
(A)
Sónia A Alves
(SA)
Melanie J Ort
(MJ)
Georg N Duda
(GN)
Alexander M Beck
(AM)
Henryk P Haffer
(HP)
Sebastian Hardt
(S)
Christian Hipfl
(C)
Vincent J Leopold
(VJ)
Sebastian Meller
(S)
Sven Märdian
(S)
Stephan Oehme
(S)
Yannick Palmowski
(Y)
Carsten Perka
(C)
Matthais Pumberger
(M)
Ulrich Stöckle
(U)
Mats J Wiethölter
(MJ)
Thomas Klein
(T)
Tazio Maleitzke
(T)
Michael Müller
(M)
Nitsan Halevy
(N)
Klaus D Schaser
(KD)
Jens Goronzy
(J)
Søren Overgaard
(S)
Andrea Papait
(A)
Petra Reinke
(P)
Simon Reinke
(S)
Antonietta R Silini
(AR)
Richard Stange
(R)
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