NCT03724617

Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium

Clinical Study of Stem Cells in the Treatment of Thin Endometrium

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.

Detailed description

According to the medical history and the results of the examination, the selected cases were screened and the informed consent was signed. After hysteroscopy, the collagen/umbilical cord mesenchymal stem cell was spread on a foley catheter, and placed in the uterine cavity, and 5 ml of saline was filled into the balloon. B-ultrasound confirmed that the stent was attached to the uterine wall. The balloon was removed in situ after 1 week. We mainly compare the endometrial thickness before and 6 months after surgery.

Conditions

• Thin Endometrium
• Intrauterine Adhesion

Interventions

Type	Name	Description
DRUG	umbilical cord mesenchymal stem cells combined with collagen scaffold	3-7 days after the end of menstruation, we underwent hysteroscopic exploration and separation if there was intrauterine adhesions. Intraoperative endometrial biopsy, recording biopsy location, endometrial specimens sent to HE examination and immunohistochemistry (vwf detection of microvessel density). The umbilical cord mesenchymal stem cell combined with collagen scaffold was spread on the balloon scaffold and placed in the uterine cavity. 5 ml of saline was filled into the balloon, and B-ultrasound confirmed that the scaffold was attached to the uterine wall. The patient was hospitalized for 2 hours and the patient's vital signs were recorded.

Timeline

• Start date: 2018-10-29
• Primary completion: 2020-06-30
• Completion: 2020-12-31
• First posted: 2018-10-30
• Last updated: 2021-04-13

Locations

1 site across 1 country: China