Immune Compatibility & Biocompatibility

Because the cellular fraction is fully autologous (donor-derived eHFSCs and DP cells) the construct is not subject to MHC-driven rejection. The risk surface therefore reduces to foreign-body response (FBR) against the synthetic scaffold and any residual contaminants.

All synthetic materials — MeHA, PLGA, PCL, PEG-dithiol, microsphere shell — are individually qualified to the ISO 10993 series: –10993-5 (cytotoxicity, MEM elution), –10993-6 (implantation 12 weeks rat subcutaneous), –10993-10 (irritation/sensitization, GLP guinea-pig maximization), –10993-11 (systemic toxicity), and –10993-23 (chemical characterization). The composite device is then run through full -10993-1 BER (biological evaluation report).

Locally, IL-10 and TGF-β3 release from the scaffold biases macrophages toward an M2 phenotype during the critical first 10 days. Endotoxin per device is held below 0.5 EU (LAL), pyrogenicity tested by monocyte activation test (MAT) per Ph. Eur. 2.6.30.