NCT03386708

hUC Mesenchymal Stem Cells (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury

A Clinical Research on the Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cell (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sclnow Biotechnology Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Healing Poor after Uterus Injury, and exploring the possible mechanisms of umbilical cord mesenchymal stem cell therapy in Healing Poor After Uterus Injury disease

Detailed description

This is a random, open label, and self-control experiment. 10 patients are selected and sign consent forms, then divided into one group. Doctors collect the basic information of patient (including age,height, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of healing Poor after Uterus Injury (Menstrual conditions, Visual analogue scale, 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 3 and 6 month after treatment, and do efficacy evaluation.

Conditions

• Uterus; Injury

Interventions

Type	Name	Description
PROCEDURE	intrauterine injection	intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times
BIOLOGICAL	human umbilical cord mesenchymal stem cell	2 \* 10\^7 cells (2ml)

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-06-01
• Completion: 2021-09-21
• First posted: 2017-12-29
• Last updated: 2022-02-04

Locations

1 site across 1 country: China