NCT06610773

HUC-MSC for Treatment of High-risk HPV Infection

Effectiveness and Safety of Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of HPV High-risk Infection

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: Female
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.

Detailed description

Cervical cancer is one of the most common malignant tumors of the female reproductive system with the highest incidence. Nearly 99.7% of cervical cancer is caused by HPV infection. Studies have shown that the persistent infection of high-risk human papillomavirus (HR-HPV) is an independent risk factor for cervical cancer which can lead to a 250-fold increased risk of high-grade cervical intraepithelial neoplasia (CIN). In patients with persistent HR-HPV infection for more than 12 months, the risk of diagnosis of high-grade squamous intraepithelial lesions of the cervix by 30 months increased to 21%. In the process of progression from HPV infection to cervical cancer, cervical precancerous lesions, namely intraepithelial neoplasia (CIN), will be experienced. Therefore, effective control of HPV infection, especially the elimination of persistent HR-HPV infection, will greatly reduce the incidence of CIN and cervical cancer. It is an urgent clinical need to actively intervene in patients with persistent infections for more than one year with a clinical significance at present. Mesenchymal Stem Cells (MSCs) are a class of pluripotent stem cells derived from the mesoderm and ectoderm of early development, which can be easily obtained from a variety of tissue organs, having a strong proliferation and multidirectional differentiation potential in vitro. hUC-MSCs have a great effect on immune regulation and anti-inflammatory properties with a fewer ethical, availability, safety issues and a broader prospect in clinical research and application. At present, many experimental data have proved that MSCs can enhance the clearance of virus by immune cells in vivo, and have a certain application prospect in fighting virus infection. The purpose of this study was to evaluate the safety and therapeutic efficacy of human umbilical cord mesenchymal stem cells (HUC-MSCs) in clearing HPV infection, and to provide clinical basis for HUC-MSCs to clear HPV infection.

Conditions

• Human Papillomavirus Viruses
• Mesenchymal Stem Cells

Interventions

Type	Name	Description
BIOLOGICAL	hUC-MSCs	1×10\^6/Kg hUC-MSCs (suspended in 100 mL normal saline containing 5% albumin) are infused intravenously to patients at a controlled rate of 60-80 drops/min.
BIOLOGICAL	Saline+albumin	Normal saline containing 5% albumin had a similar suspension and appearance package to hUC-MSCs, but no MSCs

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-09-10
• Completion: 2026-09-10
• First posted: 2024-09-24
• Last updated: 2024-09-24

Locations

1 site across 1 country: China