Industrial Development of Standardized Fetal Progenitor Cell Therapy for Tendon Regenerative Medicine: Preliminary Safety in Xenogeneic Transplantation

Tendon defects require multimodal therapeutic management over extensive periods and
incur high collateral burden with frequent functional losses. Specific cell therapies have recently
been developed in parallel to surgical techniques for managing acute and degenerative tendon tissue
affections, to optimally stimulate resurgence of structure and function. Cultured primary human
fetal progenitor tenocytes (hFPT) have been preliminarily considered for allogeneic homologous cell
therapies, and have been characterized as stable, consistent, and sustainable cell sources in vitro.
Herein, optimized therapeutic cell sourcing from a single organ donation, industrial transposition of
multi-tiered progenitor cell banking, and preliminary preclinical safety of an established hFPT cell
source (i.e., FE002-Ten cell type) were investigated. Results underlined high robustness of FE002-
Ten hFPTs and suitability for sustainable manufacturing upscaling within optimized biobanking
workflows. Absence of toxicity or tumorigenicity of hFPTs was demonstrated in ovo and in vitro,
respectively. Furthermore, a 6-week pilot good laboratory practice (GLP) safety study using a
rabbit patellar tendon partial-thickness defect model preliminarily confirmed preclinical safety of
hFPT-based standardized transplants, wherein no immune reactions, product rejection, or tumour
formation were observed. Such results strengthen the rationale of the multimodal Swiss fetal
progenitor cell transplantation program and prompt further investigation around such cell sources in
preclinical and clinical settings for musculoskeletal regenerative medicine.