JadiCell Potency Assay Study Highlights
https://pubmed.ncbi.nlm.nih.gov/34227081/

Mechanistic Breakthrough

Umbilical-cord–derived mesenchymal stem cells (UC-MSCs, branded as JadiCells) were shown to modulate critical inflammatory pathways in COVID-19-associated ARDS. The study identifies a direct mechanism: increased soluble TNF Receptor-2 (sTNFR2) leads to the neutralization of inflammatory TNFα and TNFβ, reducing the cytokine storm responsible for lung injury.

Clinical Context

The potency assay was performed on plasma samples from 24 subjects enrolled in the Phase 1/2a double-blind randomized controlled trial of UC-MSC therapy for COVID-19 ARDS. Samples were collected on Day 0 (baseline)and Day 6 (post-treatment).

Key Findings

• sTNFR2 levels increased significantly in the UC-MSC group (26,609 ± 846 pg/ml vs. 23,111 ± 760 pg/ml; p = 0.021).
• TNFα decreased from 950 ± 226 pg/ml to 319 ± 40 pg/ml (p = 0.048).
• TNFβ decreased from 2,944 ± 735 pg/ml to 810 ± 126 pg/ml (p = 0.032).
• Control subjects showed no significant change over the same period

Interpretation

These results demonstrate that JadiCells induce a regulatory immune phenotype, promoting T-cell quiescence and regulatory T-cell (Treg) expansion through sTNFR2 signaling. This pathway mirrors the mechanism used by blockbuster anti-TNF drugs (e.g., Etanercept), yet is accomplished naturally through a living-cell therapy.

Conclusion

The study provides quantitative evidence of potency and mechanistic validation for JadiCell as a biological anti-inflammatory therapy.

By boosting sTNFR2 and lowering TNFα/TNFβ, JadiCells directly suppress the cytokine storm, a hallmark of ARDS and many severe inflammatory diseases.