NCT05138367

Effects of UCA-PSCs in Women With POF

Clinical Study of Human Umbilical Artery Derived Perivascular Stem Cells in the Treatment of Premature Ovarian Failure

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Li-jun Ding · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

This study was a single-center randomized controlled trial at the Affiliated Drum Tower Hospital of Nanjing University Medical School. There were patients who underwent clinical follow-ups since 2018 in POF clinic. Patients were given treatment of either UCA-PSC or WJ-MSC.

Detailed description

At entry, all patients had already received a standard non-physiologic hormone replacement regimen. According to blinded preferences for participation, patients were randomized into two treatment groups after an initial 2-month washout period of no therapy. One group received UCA-PSC transplantation plus horone replacement treatment (HRT) (UCA-PSC group), while the other group received WJ-MSC transplantation plus HRT (collagen/WJ-MSC group)

Conditions

• Premature Ovarian Failure

Interventions

Type	Name	Description
PROCEDURE	transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients	After vaginal sterilization, TVUS-guided transplantation was performed by the senior-level medical physician B Wang), using a SIEMENS ACUSON ANTANES premium edition system (SIEMENS AG Healthcae Sector, Erlangen, Germany), equipped with a 6-10 MHz probe. The solution (a total number of 2×10\^7cells, 1×10\^7 /400 μL for unilateral ovarian injection) was injected into the ovary by using 21G PTC needles (Hakko Medical Co, Japan) under TVUS guiance. Each patent received up to three transplantations.

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2021-12-01
• Last updated: 2021-12-01

Locations

1 site across 1 country: China