NCT04232592

Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Qi Zhou · Other Government
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

To observe the clinical safety of intrauterine injection of human embryonic stem cell derived mesenchymal cells in the treatment of moderate and severe intrauterine adhesion, and to preliminarily explore its clinical effectiveness in promoting endometrial regeneration and repair.

Detailed description

In this study, a single-center, controlled, open-label design was used for a dose escalation study.To observe the clinical safety of intrauterine injection of human embryonic stem cell derived mesenchymal cells in the treatment of moderate and severe intrauterine adhesion, and to preliminarily explore its clinical effectiveness in promoting endometrial regeneration and repair.

Conditions

• Intrauterine Adhesion

Interventions

Type	Name	Description
BIOLOGICAL	Inject a solution of stem cell preparation	The control group was injected with a solution of stem cell preparation
BIOLOGICAL	Inject stem cells	Three dose groups were designed: low dose group, medium dose group and high dose group.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2020-01-18
• Last updated: 2020-01-18