Wolwo Bio Subsidiary Receives Chinese Trial Authorization for Umbilical Cord Mesenchymal Stem Cell Therapy for Sepsis

Key Points

• China’s National Medical Products Administration has authorized clinical trials of Human Umbilical Cord Mesenchymal Stem Cell Type II Injection for sepsis and/or septic shock.
• The product was developed by Zhejiang Wolwo’s indirectly controlled subsidiary, Zhejiang Wolwo Stem Cell Technology, and contains human umbilical cord-derived mesenchymal stem cells.
• Sepsis and/or septic shock is the subsidiary’s first stem cell drug indication.

Zhejiang Wolwo, a biotechnology company focused on the diagnosis and treatment of allergic diseases, announced that its indirectly controlled subsidiary, Zhejiang Wolwo Stem Cell Technology, received authorization from China’s National Medical Products Administration to conduct clinical trials of Human Umbilical Cord Mesenchymal Stem Cell Type II Injection for sepsis and/or septic shock.

Sepsis and septic shock

Sepsis is a clinical syndrome in which a dysregulated host response to infection causes life-threatening organ dysfunction. Septic shock involves severe circulatory, cellular and metabolic abnormalities and carries a higher risk of death. Both conditions can lead to multiple organ dysfunction, while survivors may experience persistent cognitive impairment and organ dysfunction.

Treatment strategies primarily involve supportive care and broad-spectrum antimicrobial drugs. Despite advances in fluid resuscitation, vasoactive drugs and organ support, mortality and long-term complications remain substantial.

The investigational cell product

Zhejiang Wolwo Stem Cell Technology independently developed the injection, which contains human umbilical cord-derived mesenchymal stem cells (MSCs). The company highlighted the cells’ immunomodulatory, tissue-repair and low-immunogenicity characteristics as the rationale for exploring their use in critical illness and regenerative medicine.

The subsidiary selected sepsis and/or septic shock as its first stem cell drug indication to address unmet clinical needs in this area. According to Zhejiang Wolwo, no MSC drug had been approved for marketing in China or elsewhere for treating sepsis and septic shock.

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