NCT05308342

Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Li-jun Ding · Academic / Other
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

This study was a single-center, randomized, controlled prospective study. Those who had premature ovarian failure and who had fertility requirements were enrolled in the study. To determine the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of patients with POI.

Detailed description

According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells (test group). Group B was the hormone replacement group (control group).

Conditions

• Premature Ovarian Insufficiency

Interventions

Type	Name	Description
PROCEDURE	transplantation of human UC-MSCs into ovaries of POI patients	UC-MSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the China Food and Drug Administration) are injected into the ovary of patients under transvaginal ultrasonographic (TVUS)-guidance. A total number of 10×106 cells, 5×106 for unilateral ovarian injection) is immediately preserved and transferred for direct injection. After vaginal sterilization, TVUS-guided transplantation is performed by two senior-level medical physicians, using a SIEMENS ACUSON ANTANES premium edition system (SIEMENS AG Healthcare Sector, Erlangen, Germany), equipped with a 6-10 MHz probe. The UC-MSC solution is injected into the ovary by using 21-G PTC needles (Hakko Medical Co, Japan) under TVUS guidance.
DRUG	hormone replacement treatment	Routine estrogen progesterone replacement periodic therapy

Timeline

• Start date: 2019-11-20
• Primary completion: 2023-07-31
• Completion: 2023-12-01
• First posted: 2022-04-04
• Last updated: 2022-04-04

Locations

1 site across 1 country: China