NCT04706312

Transplantation of hAMSCs for Woman With DOR

The Safety and Efficacy Assessment of Human Amniotic Mesenchymal Stem Cells(hAMSCs) Transplantation in Woman With Diminished Ovarian Reserve (DOR)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 35 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Patients with Diminished ovarian response (DOR）have a poor in vitro fertilization（IVF） outcome, and is considered one of most challenging tasks in artificial reproductive treatment (ART). Stem cell therapies are rapidly progressing fields and have shown promise in treatment of lots of disease, including aging and premature ovarian failure. The purpose of this study is to determine the safety and efficacy of intra vein injection of human Amniotic Mesenchymal Stem Cells(hAMSCs) in women suffered from infertility caused by DOR.

Detailed description

Patients with Diminished ovarian response (DOR）have a poor in vitro fertilization（IVF） outcome, and is considered one of most challenging tasks in artificial reproductive treatment (ART). Stem cell therapies are rapidly progressing fields and have shown immense promise in the treatment of lots of disease, including aging and premature ovarian failure. The purpose of this study is to determine the safety and efficacy of intra vein injection of human amniotic mesenchymal stem cells(hAMSCs) in women suffered from infertility caused by DOR. The hAMSCs were isolated and cultured in vitro and qualified by National Institutes for Food and Drug Control, China. The serum of each patient was kept and sent for laboratory test before the transplantation. The biomarkers of hAMSCs were detected again before transplantation. The hAMSCs were transplanted via venous in the dorsum of hand. The outcomes of patients were examined during and after the injection. The patients are monitored for hormones, follicles stimulated with minimal stimulation, number of oocyte retrieval and embryos In Vitro Fertilization (IVF).

Conditions

• Diminished Ovarian Response

Interventions

Type	Name	Description
OTHER	stem cells	hAMSCs injection via venous in the dorsum of hand

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-01-01
• Completion: 2024-04-01
• First posted: 2021-01-12
• Last updated: 2021-02-09

Locations

1 site across 1 country: China