Umbilical Cord Mesenchymal Stem Cell Injection (E10I)

E10I is a cryopreserved stem cell formulation independently developed by Doublle Biotech. It is prepared from umbilical cord tissue through isolation, screening, and large‑scale 3D expansion. In March 2025, it received NMPA clinical trial approval for the treatment of type 2 diabetes mellitus.

E10I®

Umbilical Cord Mesenchymal Stem Cell Injection
Doublle Biotech · First‑in‑China 3D‑cultured hUC‑MSCs for type 2 diabetes
NMPA Approved (2025) Phase I Clinical Trial Type 2 Diabetes 3D Large‑Scale Production
🛡️ Immunomodulatory effects – reduces systemic inflammation & improves insulin resistance
🔄 Macrophage polarization – promotes M2 anti‑inflammatory phenotype in diabetic microenvironment
🧬 Tri‑lineage differentiation capacity – confirmed adipogenic, osteogenic & chondrogenic potential
🏭 Automated 3D expansion – scalable, consistent GMP‑grade manufacturing
🔬 Indication: Type 2 Diabetes Mellitus
📞 Contact Us · Request Information

🔬 Mechanism & Quality Studies
Immunomodulation & Cell Characterization

UC‑MSCs improve the immune microenvironment by blocking inflammasome activation, reducing inflammatory cytokine release, and lowering systemic inflammation, thereby alleviating insulin resistance. In the diabetic inflammatory milieu, UC‑MSCs promote macrophage polarization toward the anti‑inflammatory M2 phenotype, reducing inflammatory activity and enhancing insulin sensitivity in target tissues.

UC-MSC mechanism of action Mechanism diagram

Mechanism of UC‑MSCs in the inflammatory microenvironment

Reference: Chen CL, et al. Immunomodulatory effects of umbilical cord mesenchymal stem cells on type 2 diabetes. Chinese Journal of Tissue Engineering Research. 2025;29(23):5031‑5040.

Quality Studies: Proliferation & Differentiation

Colony formation assays demonstrate high viability and clonogenic potential. E10I exhibits robust trilineage differentiation capacity, confirmed by adipogenic, osteogenic, and chondrogenic induction under specific culture conditions.

Colony formation and trilineage differentiation Osteogenic differentiation Chondrogenic differentiation
✨ GMP‑compliant 3D bioprocessing | High viability & multilineage potential

📊 Preclinical Efficacy & Clinical Status
Long‑acting therapy for type 2 diabetes

E10I is designed as a long‑acting therapeutic for diabetes. Preclinical pharmacodynamic studies have demonstrated its capacity to improve insulin sensitivity, reduce fasting blood glucose, and restore pancreatic islet function in diabetic models.

Preclinical pharmacodynamic study results

✅ NMPA Clinical Trial Approval (March 2025)
✅ Phase I study actively recruiting
✅ 3D automated large‑scale manufacturing platform
✅ Promising long‑term safety & efficacy profile

🏅 First‑in‑China hUC‑MSCs for type 2 diabetes | Innovative immunotherapy approach
✔️ NMPA Phase I Approval (2025) ✔️ 3D Automated Production Platform ✔️ Immunomodulatory Mechanism ✔️ Trilneage Differentiation Confirmed
*Additional preclinical and manufacturing data available upon request
© Doublle Biotech · Umbilical Cord Mesenchymal Stem Cell Injection E10I · For medical professionals only
This page is for scientific and product information purposes only, not a substitute for medical advice.