drugset / Trial / NCT03816852

The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency

NCT03816852

Phase 2 Suspended 12 enrolled Sclnow Biotechnology Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode, meanwhile compare with hormone replacement therapy (HRT) withdrawal, so that assessing the stem cell therapy.

Timeline

Start
2018-10-01
Primary completion
2026-12-31
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject human umbilical cord mesenchymal stem cells Cell therapy 3e+07 cells Intravenous
Subject human umbilical cord mesenchymal stem cells Cell therapy 6e+07 cells Intravenous
Subject human umbilical cord mesenchymal stem cells Cell therapy 9e+07 cells Intravenous