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Stem Cell Therapy

Stem Cell-Derived Exosomes for Diminished Ovarian Reserve (VL-POI-01 Trial)

Phase 1
Waitlist Available
Research Sponsored by Vitti Labs, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal uterine anatomy (by any clinically and/or imaging acceptable methods)
Diagnosis of premature ovarian insufficiency based on ESHRE Guidelines
Must not have
Subjects with history of thromboembolic events such as pulmonary embolism, stroke, or ischemic heart disease
Subjects with uncontrolled hypertension, kidney disease, liver disease, or polycystic ovary syndrome (PCOS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment using tiny particles from placental cells to help women with premature ovarian insufficiency. These particles help cells in the ovaries repair themselves and work better. The goal is to improve hormone production, egg development, and overall quality of life for these women. These particles have shown promise in treating various conditions by aiding in cell repair.

Who is the study for?
Women aged 18-43 with premature ovarian insufficiency (POI) or diminished ovarian reserve, not currently pregnant or breastfeeding, without recent cancer history. Must have normal chromosomes and thyroid function, no severe allergies to certain medications, and be willing to report pregnancies and follow study protocols.
What is being tested?
The trial is testing EV-Pure™ derived from human placental mesenchymal stem cells for safety and effectiveness in treating POI. Participants will receive exosome treatment to see if it can improve their ovarian function.
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to the immune system due to new biological treatments. Patients will be monitored closely for any adverse effects throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My uterus is normal according to tests or imaging.
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I have been diagnosed with early menopause.
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I have a normal female chromosome set and no history of fragile X syndrome.
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I have a history of endometriosis or polycystic ovarian syndrome.
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I have been diagnosed with premature ovarian insufficiency or low ovarian reserve.
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My uterus is normal in shape and function.
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I am a woman aged between 18 and 43.
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I have at least one ovary.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a blood clot, stroke, or heart-related issue.
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I do not have uncontrolled high blood pressure, kidney, liver disease, or PCOS.
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I have untreated hormonal disorders like Cushing's or thyroid disease.
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I have had a deep vein clot or lung clot before.
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I have had a stroke or other brain blood flow problems.
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I have a known heart condition.
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I have a genetic condition related to fragile X syndrome or a family history of early menopause.
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I have diabetes or have been on diabetes medication in the last 3 months.
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I have been diagnosed with anemia.
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I have had breast, ovarian, or other hormone-related cancer in the last 5 years.
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I have a known liver disease.
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I have a known kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Anti-Müllerian Hormone Levels
Antral Follicle Counts
Estradiol Levels
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Premature Ovarian Failure (POF) include hormone replacement therapy (HRT), which works by supplementing estrogen and progesterone to alleviate symptoms and reduce the risk of osteoporosis. Another emerging treatment is the use of mesenchymal stem cell-derived exosomes, which are being studied for their potential to repair and regenerate ovarian tissue. These exosomes can deliver bioactive molecules that promote cellular repair, reduce inflammation, and enhance tissue regeneration. This is particularly important for POF patients as it offers a potential to restore ovarian function and improve fertility, addressing the root cause rather than just managing symptoms.

Find a Location

Who is running the clinical trial?

Vitti Labs, LLCLead Sponsor
2 Previous Clinical Trials
40 Total Patients Enrolled
~4 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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