NCT02603744

Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)

Evaluate the Safety and Feasibility of Intra-ovarian Injection of Autologous Adipose Derived Mesenchymal Stromal Cells (ADMSC) in Women With Premature Ovarian Failure(POF)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Royan Institute · Other Government
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine safety and tolerability and of intra-ovarian injection of adipose derived stromal cell in women with premature ovarian failure and to study the preliminary efficacy ADSCs intra ovarian injection on ovarian function improvement.

Detailed description

In this study 9 patients with the diagnosis of premature ovarian failure will participate. The patients will be divided randomly in 3 groups, each group contains 3 patients. First group will receive 5 millions of ADSCs, second group receive 10 millions cells and the third group receive 15millions of ADSCs. Stem cell Transplantation method is intraovarian injection of ADSCs which will be performed under guidance of transvaginal sonography. All the patients will be followed for 12 months after cell injection to evaluate any adverse events .

Conditions

• Premature Ovarian Failure

Interventions

Type	Name	Description
BIOLOGICAL	Intraovarian injection of Adipose derived Stromal cells (ADSCs)	Intra-ovarian injection of Adipose derived mesenchymal stem cells.

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-06-01
• Completion: 2018-11-01
• First posted: 2015-11-13
• Last updated: 2017-04-27

Locations

1 site across 1 country: Iran