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The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) With Injectable Collagen Scaffold Transplantation in Woman With Premature Ovarian Failure (POF)
Cellular therapies are rapidly progressing fields and have shown immense promise in the treatment of damaged ovarian function. The purpose of this study is to determine safety and efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.
The purpose of this study was to explore the therapeutic potency of the HUC-MSCs with injectable collagen scaffold transvaginal injection for POF women. The serum of each patient was kept and sent for laboratory test before the surgery. HUC-MSCs were isolated and cultured in vitro and the biomarkers of HUC-MSCs were detected using Flow cytometry detection. The HUC-MSCs with injectable collagen scaffold were then injected directly into bilateral ovaries. The outcomes of patients were examined after the injection. The patients are monitored for signs of follicle growth and growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and In Vitro Fertilization (IVF).
Age
20 - 39 years
Sex
FEMALE
Healthy Volunteers
No
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Start Date
October 1, 2015
Primary Completion Date
October 1, 2018
Completion Date
October 1, 2018
Last Updated
January 13, 2020
23
ACTUAL participants
HUC-MSCs Transplantation
BIOLOGICAL
HUC-MSCs with Injectable Collagen Scaffold Transplantation
BIOLOGICAL
Lead Sponsor
Chinese Academy of Sciences
Collaborators
NCT04390308
NCT04815213
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04189406