What side effects are associated with this type of intervention?

The most common treatments for Premature Ovarian Failure (POF) include hormone replacement therapy (HRT) and emerging therapies like human placental mesenchymal stem cell derived exosome treatment. HRT can cause side effects such as bloating, breast tenderness, headaches, mood swings, and an increased risk of blood clots and certain cancers. For cellular repair and regeneration therapies, including stem cell-derived exosome treatments, potential side effects are still being studied, but they may include immune reactions, infection, and local inflammation at the injection site. Patients should discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Premature Ovarian Failure (POF) that focus on cellular repair and regeneration similar to Human Placental Mesenchymal Stem Cell Derived Exosome Treatment. Traditional treatments for POF primarily involve hormone replacement therapy (HRT) to manage symptoms and prevent complications associated with estrogen deficiency. Other investigational treatments, such as stem cell therapy, are still in the experimental stages and have not yet received FDA approval.

What other types of research exist?

Promising alternatives to Human Placental Mesenchymal Stem Cell Derived Exosome Treatment for Premature Ovarian Failure patients include: 1) In vitro activation (IVA) of ovarian follicles, which involves stimulating dormant follicles to grow and mature; 2) Platelet-rich plasma (PRP) ovarian rejuvenation, which uses growth factors from the patient's own blood to potentially improve ovarian function; 3) Ovarian tissue cryopreservation and transplantation, which involves freezing ovarian tissue for future use; and 4) Advanced assisted reproductive technologies (ART) such as in vitro fertilization (IVF) with preimplantation genetic testing (PGT) to enhance the chances of successful pregnancy.

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Stem Cell Therapy

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

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

VL-POI-01 Trial Summary

This trial tests a new stem cell treatment to improve fertility for women with POI or diminished ovarian reserve.

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.Check my eligibility

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.See study design

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.

VL-POI-01 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.

VL-POI-01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

Anti-Müllerian Hormone Levels

Antral Follicle Counts

Estradiol Levels

+1 more

VL-POI-01 Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

0 / 8Eligibility criteria met

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.

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Who is running the clinical trial?

Vitti Labs, LLCLead Sponsor

2 Previous Clinical Trials

40 Total Patients Enrolled

~6 spots leftby Oct 2025

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