Abstract
Diverse cell therapy approaches constitute prime developmental prospects for managing acute or degenerative cartilaginous tissue affections, synergistically complementing specific surgical solutions. Bone marrow stimulation (i.e., microfracture) remains a standard technique for cartilage repair promotion, despite incurring the adverse generation of fibrocartilagenous scar tissue, while matrix-induced autologous chondrocyte implantation (MACI) and alternative autologous cell-based approaches may partly circumvent this effect. Autologous chondrocytes remain standard cell sources, yet arrays of alternative therapeutic biologicals present great potential for regenerative medicine. Cultured human epiphyseal chondro-progenitors (hECP) were proposed as sustainable, safe, and stable candidates for chaperoning cartilage repair or regeneration. This study describes the development and industrial transposition of hECP multi-tiered cell banking following a single organ donation, as well as preliminary preclinical hECP safety. Optimized cell banking workflows were proposed, potentially generating millions of safe and sustainable therapeutic products. Furthermore, clinical hECP doses were characterized as non-toxic in a standardized chorioallantoic membrane model. Lastly, a MACI-like protocol, including hECPs, was applied in a three-month GLP pilot safety evaluation in a caprine model of full-thickness articular cartilage defect. The safety of hECP transplantation was highlighted in xenogeneic settings, along with confirmed needs for optimal cell delivery vehicles and implantation techniques favoring effective cartilage repair or regeneration.
Highlights
Demographic shifts of recently increasing amplitude incur heightened incidence and prevalence of chronic degenerative diseases, stimulating translational research eventually providing novel therapeutic solutions toward optimally managing structural tissue repair and functional restoration [1,2]
This study describes the industrial transposition of human epiphyseal chondro-progenitors (hECP) multi-tiered cell banking for therapeutic product development, following a single fetal organ donation, for optimized cartilage defect repair or regeneration
HECP clinical cell doses were characterized as non-embryotoxic and non-angiotoxic in a standardized chorioallantoic membrane model, with an absence of significantly induced mortality in exposed embryos
Summary
Demographic shifts of recently increasing amplitude incur heightened incidence and prevalence of chronic degenerative diseases, stimulating translational research eventually providing novel therapeutic solutions toward optimally managing structural tissue repair and functional restoration [1,2]. The developmental bedrock of regenerative medicine continuously contributes to the democratization of cell-based or cell-derived products and therapies, purposed with the prevention and treatment of diverse musculoskeletal affections, ranging from acute traumatic wounds to degenerative wear-related defects. The latter predominate translational research revolving around cartilage tissue repair, as attested to by the emergence of numerous specific cell therapies and combined bioengineered constructs [3,4,5]. The physical and biomechanical properties of cartilage tissue parallelly prompt the development of effective surgical and therapeutic product delivery techniques, as various approaches currently deployed (e.g., microfracture, autologous chondrocyte implantation) may fall short of patient and clinician expectations with regard to outcomes (Table 1)
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