NCT05495711

hUC Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility

A Clinical Research on Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sclnow Biotechnology Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

To explore the therapeutic effect and safety of human umbilical cord mesenchymal stem cells on thin endometrial infertility and to explore whether human umbilical cord mesenchymal stem cells using collagen as the carrier can promote endometrial growth, reduce the recurrence rate of intrauterine adhesion, increase the clinical pregnancy rate, improve the pregnancy outcome, and study its safety.

Detailed description

This is a random, open label, and self-control experiment. 24 patients are selected and sign consent forms, then divided into two groups. Doctors collect the basic information of patient (including age, BMI, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of thin endometrial infertility (menstrual conditions, uterine cavity form, pregnancies). All patients receive laboratory and image examination as baseline. Then, cell treatment will be given based on the clinical protocol. Doctors have follow-up visit on 1, 3, 6, 12 month after treatment, and do efficacy evaluation.

Conditions

• Infertility, Female

Interventions

Type	Name	Description
BIOLOGICAL	human umbilical cord mesenchymal stem cell complex collagen	1 \* 10\^7 cells (2ml)
PROCEDURE	intrauterine injection	intrauterine injection with human umbilical cord mesenchymal stem cell (19#iSCLife®-UT); total 1 time

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-06-01
• Completion: 2023-11-01
• First posted: 2022-08-10
• Last updated: 2025-05-22

Locations

1 site across 1 country: China