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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

Find a Location

Who is running the clinical trial?

Vitti Labs, LLCLead Sponsor

2 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants who exceed 30 years of age accepted for this research?

"In accordance with the trial's requirements, participants must be aged 18 or above and no older than 43."

Answered by AI

Has Treatment Arm been given the greenlight from the FDA?

"Preliminary data suggests that Treatment Arm is safe, and thus received a score of 1. This rating is based on it being an early-phase trial with few studies done to evaluate both safety and efficacy."

Answered by AI

Is it still possible to join the experiment at this juncture?

"According to the clinicaltrials.gov database, this medical study is open for recruitment and has recently been updated on October 25th 2023. It was initially posted on October 6th of last year."

Answered by AI

How many individuals have opted into this research endeavor?

"Affirmative. Clinicaltrials.gov has verifiable proof that this medical trial, initially published on October 6th 2023, is currently recruiting participants. The study requires 9 individuals to be recruited from one healthcare centre."

Answered by AI

Who would be an eligible participant for this research project?

"Applicants for this trial must be between the ages of 18 and 43, have been diagnosed with premature ovarian failure using ESHRE Guidelines, possess a 46 XX karyotype without FMR1 premutation (fragile X Syndrome), demonstrate basal FSH values >10 IU/L or poor response to assisted reproductive therapy attempts, AMH levels ≤ 1.0 ng/mL in at least one functioning ovary as well as normal uterine anatomy verified by acceptable methods, and finally pass all necessary thyroid tests. Furthermore they should not only understand English but also agree to report any pregnancies directly to research staff."

Answered by AI

Who else is applying?

What site did they apply to?

Optimal Health Associates

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

Why did patients apply to this trial?

I’m hoping to improve my ovarian reserve so that I can do IVF. It’s also very costly so am looking for support for these treatments.

PatientReceived 1 prior treatment

I would really like to be able to conceive and carry another child, as well as protect my long term health with proper working hormones.

PatientReceived 2+ prior treatments

I am an 18-year-old girl who recently found out that she is diagnosed with premature ovarian failure and I would like to contribute to science and myself as much knowledge as possible that may also advance medicine so that I or others like me can have children of our own one day.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072794.

All > Premature Ovarian Failure