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

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 the treatment using stem cell-derived exosomes generally safe for humans?

The research primarily focuses on animal models, showing that stem cell-derived exosomes can improve ovarian function without mentioning specific safety concerns. However, these studies do not provide direct evidence of safety in humans. ^{1 2 3 4 5}

How is the treatment EV-Pure™ different from other treatments for diminished ovarian reserve?

EV-Pure™ is unique because it uses exosomes (tiny particles that carry signals between cells) derived from stem cells to potentially restore ovarian function. This approach is novel compared to traditional treatments, as it focuses on regenerative medicine to improve ovarian health, rather than just managing symptoms. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment EV-Pure™ for diminished ovarian reserve?

Research shows that exosomes (tiny particles released by cells) from stem cells can improve ovarian function in conditions similar to diminished ovarian reserve, like primary ovarian insufficiency. These exosomes have been shown to help restore ovarian function in animal studies by carrying specific molecules that promote cell growth and reduce damage. ^{3 4 5 6 7}

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. Ireland pubmed.ncbi.nlm.nih.gov

Human umbilical cord mesenchymal stem cell-derived extracellular vesicles improve ovarian function in rats with primary ovarian insufficiency by carrying miR-145-5p. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Regenerative potential of different extracellular vesicle subpopulations derived from clonal mesenchymal stem cells in a mouse model of chemotherapy-induced premature ovarian failure. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Exosomes derived from human adipose mesenchymal stem cells improve ovary function of premature ovarian insufficiency by targeting SMAD. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Exosomal miRNA-17-5p derived from human umbilical cord mesenchymal stem cells improves ovarian function in premature ovarian insufficiency by regulating SIRT7. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles Carrying MicroRNA-29a Improves Ovarian Function of Mice with Primary Ovarian Insufficiency by Targeting HMG-Box Transcription Factor/Wnt/β-Catenin Signaling. [2022]

6. China pubmed.ncbi.nlm.nih.gov

Extracellular vesicles from iPSC-MSCs alleviate chemotherapy-induced mouse ovarian damage via the ILK-PI3K/AKT pathway. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Concentrated exosomes from menstrual blood-derived stromal cells improves ovarian activity in a rat model of premature ovarian insufficiency. [2021]