NCT05697718

Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-S) in the Treatment of Ischemic Stroke

A Phase I Study of Safety and Tolerability of Single-dose Human Umbilical Cord Mesenchymal Stem Cell (IxCell hUC-MSC-S) in Patients With Convalescent Phase of Ischemic Stroke

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Shanghai IxCell Biotechnology Co., LTD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of IxCellhUC-MSC-S as a single intravenous infusion in convalescent patients with ischemic stroke. To explore the efficacy of IxCellhUC-MSC-S as a single intravenous infusion in patients with convalescent ischemic stroke.

Detailed description

MSCs are a type of stem cells derived from mesoderm with multidirectional differentiation potential. Studies have shown that MSCs have the potential to differentiate not only to bone, cartilage, fat and myogenic cells, but also to neurons.Among them, human cord blood mesenchymal stem cells are a kind of mature mesenchymal stem cells currently used. Human cord blood mesenchymal stem cells are ideal seed cells for tissue engineering. In addition to the advantages of convenient acquisition, rich source, easy expansion, etc., human cord blood collection also has the following advantages: (1) Collection of cord blood has no harm to maternal and newborn;(2) The cells are more primitive and have stronger ability of proliferation and differentiation;(3) Low immunogenicity, strong tolerance to human leukocyte antigen and low incidence of rejection;(4) The infection and transmission probability of tumor cells, viruses and pathogenic microorganisms is relatively low;(5) It does not involve many controversies in social, ethical and legal aspects.Current studies believe that the possible mechanisms of human umbilical cord mesenchymal stem cells in the treatment of stroke include replacing damaged nerve cells, promoting the proliferation and differentiation of endogenous nerve cells, secreting neurotrophic factors, promoting angiogenesis, reducing nerve cell apoptosis, and inhibiting inflammation.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
BIOLOGICAL	MSC	a single injection dose i.v.

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-07-29
• Completion: 2024-08-27
• First posted: 2023-01-26
• Last updated: 2026-02-12

Locations

2 sites across 1 country: China