Evaluation of a cell-based osteogenic formulation compliant with good manufacturing practice for use in tissue engineering.
Mol Biol Rep
; 47(7): 5145-5154, 2020 Jul.
Article
in En
| MEDLINE
| ID: mdl-32562174
ABSTRACT
Proper bony tissue regeneration requires mechanical stabilization, an osteogenic biological activity and appropriate scaffolds. The latter two elements can be combined in a hydrogel format for effective delivery, so it can readily adapt to the architecture of the defect. We evaluated a Good Manufacturing Practice-compliant formulation composed of bone marrow-derived mesenchymal stromal cells in combination with bone particles (Ø = 0.25 to 1 µm) and fibrin, which can be readily translated into the clinical setting for the treatment of bone defects, as an alternative to bone tissue autografts. Remarkably, cells survived with unaltered phenotype (CD73+, CD90+, CD105+, CD31-, CD45-) and retained their osteogenic capacity up to 48 h after being combined with hydrogel and bone particles, thus demonstrating the stability of their identity and potency. Moreover, in a subchronic toxicity in vivo study, no toxicity was observed upon subcutaneous administration in athymic mice and signs of osteogenesis and vascularization were detected 2 months after administration. The preclinical data gathered in the present work, in compliance with current quality and regulatory requirements, demonstrated the feasibility of formulating an osteogenic cell-based tissue engineering product with a defined profile including identity, purity and potency (in vitro and in vivo), and the stability of these attributes, which complements the preclinical package required prior to move towards its use of prior to its clinical use.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Osteogenesis
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Hydrogels
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Tissue Engineering
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Tissue Scaffolds
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Mesenchymal Stem Cells
Type of study:
Evaluation_studies
Limits:
Animals
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Female
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Humans
Language:
En
Journal:
Mol Biol Rep
Year:
2020
Document type:
Article
Affiliation country: