NCT06072794

A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI)

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Vitti Labs, LLC · Industry
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

The VL-POI-01 study is designed to evaluate the safety and efficacy of human placental mesenchymal stem cell derived exosome treatment in patients with premature ovarian insufficiency (POI) and diminished ovarian reserve.

Detailed description

Premature ovarian insufficiency (POI) is a devastating disease for young women who have not yet completed childbearing. The prevalence of this condition is on the rise due to the increasing number of cancer survivors and the delay in childbearing age. Current treatment options available are very limited. Stem cell therapy has been shown to be beneficial and effective in various disease processes and the safety has been assessed in multiple clinical trials. The regenerative potential of mesenchymal stem cells is increasingly attributed to the paracrine effects of exosomes. Exosomes consist of bioactive lipids, nucleic acids, and proteins which play a key role in intercellular communication. Exosome therapy is considered a safe and effective therapy since it offers a cell-free approach. VL-PX10 is a decellularized exosome product derived from human placental derived mesenchymal stem cells. This interventional pilot study will investigate the ability of intravenous injection of VL-PX10 to restore steroidogenesis, folliculogenesis, and support quality of life improvement, resumption of menstruation, and reversal of infertility in patients with POI and diminished ovarian reserve. This is an open label study. All patients entering this study will be treated with VL-PX10. Participant duration will be approximately 12 months.

Conditions

• Premature Ovarian Insufficiency
• Diminished Ovarian Reserve

Interventions

Type	Name	Description
DRUG	VL-PX10	VL-PX10 is a decellularized product consisting of proteins, lipids, and nucleic acids derived from human placenta mesenchymal stem cells.

Timeline

• Start date: 2023-10-06
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2023-10-10
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study