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

NCT06072794 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Premature Ovarian Insufficiency
  • Diminished Ovarian Reserve

Interventions

DRUG

VL-PX10

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

Sponsors & Collaborators

  • Vitti Labs, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-06
Primary Completion
2025-10-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06072794 on ClinicalTrials.gov