Stem Cell-Derived Exosomes for Diminished Ovarian Reserve

(VL-POI-01 Trial)

Overseen By Mukesh Kumar, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Vitti Labs, LLC

Must not be taking: Corticosteroids, Hormones, Anticoagulants, others

Disqualifiers: Pregnancy, Cancer, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EV-Pure™, derived from stem cells, to determine its safety and effectiveness for women with premature ovarian insufficiency (POI) or diminished ovarian reserve. POI occurs when the ovaries stop functioning normally before age 40, causing irregular periods and fertility issues. Women with irregular periods for at least four months and low ovarian reserve may be suitable candidates. The primary goal is to explore whether this treatment can improve ovarian function. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. If you are currently using oral or systemic corticosteroids, hormones, or certain other medications, you must stop them at least 2 weeks before the trial. Hormonal treatments for osteoporosis or other conditions must be stopped 3 months before the trial.

Is there any evidence suggesting that EV-Pure™ is likely to be safe for humans?

Research has shown that stem cell-derived exosomes, such as those in EV-Pure™, have shown promise in animal studies. These studies suggest that the treatment might improve ovarian function. However, they do not provide specific safety details for humans. As a Phase 1 trial, this is the first time researchers are testing this treatment in humans to assess its safety. Therefore, no previous human safety data exists. Participants in this trial will help determine if the treatment is safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for diminished ovarian reserve, which typically involve hormone therapy to stimulate the ovaries, EV-Pure™ is derived from stem cell-derived exosomes. These exosomes act as tiny messengers that may help rejuvenate the ovaries by promoting cellular communication and tissue repair. Researchers are excited about EV-Pure™ because it targets the underlying issues of ovarian health at a cellular level, potentially offering a more natural and regenerative approach compared to conventional hormone-based treatments.

What evidence suggests that EV-Pure™ might be an effective treatment for diminished ovarian reserve?

In this trial, participants will receive EV-Pure™, a treatment involving stem cell-derived exosomes. A previous study showed that these tiny particles could improve ovarian function in conditions like diminished ovarian reserve. Research indicates that these cell-released particles have improved outcomes in animal models with premature ovarian failure, suggesting they might enhance fertility. Studies have found that these exosomes can increase the growth of ovarian follicles (tiny sacs in the ovaries where eggs develop) and reduce the breakdown of these sacs. This suggests that the treatment could boost ovarian health and potentially improve fertility. While human data remains limited, early findings offer hope for those with conditions affecting their ovarian reserve. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to understand and communicate in English language

I have been diagnosed with early menopause.

I have a normal female chromosome set and no history of fragile X syndrome.

Exclusion Criteria

You have a serious mental health condition that makes it difficult for you to take part in the study.

I had breast or estrogen-related cancer within the last 5 years.

You are allergic to low-molecular-weight heparin sodium or human albumin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous injection of VL-PX10 to restore steroidogenesis, folliculogenesis, and support quality of life improvement

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EV-Pure™

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vitti Labs, LLC

Lead Sponsor

Trials

3

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10744991/

Stem-Cell-Derived Extracellular Vesicles - PubMed Central Diminished ovarian reserve and premature ovarian insufficiency hinder IVF success—about 20% of in vitro fertilization (IVF) patients face a poor ...

2. withpower.com withpower.com/trial/phase-1-premature-birth-9-2023-49e28

Stem Cell-Derived Exosomes for Diminished Ovarian ... Research shows that exosomes (tiny particles released by cells) from stem cells can improve ovarian function in conditions similar to diminished ovarian reserve ...

3. ovarianresearch.biomedcentral.com ovarianresearch.biomedcentral.com/articles/10.1186/s13048-024-01489-y

Stem cell-derived extracellular vesicles in premature ovarian ... Stem cell-derived EVs demonstrate safety and efficacy in treating POF animal models, with potential improvements in fertility outcomes.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06072794

NCT06072794 | A Proof of Concept Study to Evaluate ... 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 ...

5. frontiersin.org frontiersin.org/journals/cell-and-developmental-biology/articles/10.3389/fcell.2023.1090997/full

Stem cell-derived extracellular vesicles: A novel and ... Studies have found that stem cell-derived extracellular vesicles could improve ovarian reserve, increase the growth of follicles, reduce follicle atresia, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11382489/

Stem cell-derived extracellular vesicles in premature ovarian ... Stem cell-derived extracellular vesicles in premature ovarian failure: an up-to-date meta-analysis of animal studies