AzTrials
AzTrials

Premature Ovarian InsufficiencyPhase 1VL-POI-01NCT06072794

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

A Phase 1 study testing VL-PX10 in people with Premature Ovarian Insufficiency and Diminished Ovarian Reserve, run by Vitti Labs, LLC at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial summary

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 premature ovarian insufficiency (POI) and diminished ovarian reserve. Read more about this study

Who is it for?
Ages 18 to 43 years, women only
What is being tested?
VL-PX10
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
6 Oct 2023to Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 43 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Able to understand and communicate in English language
  • Female of age 18-43 years
  • Diagnosis of premature ovarian insufficiency based on ESHRE Guidelines (i) oligo/amenorrhea for at least 4 months, and (ii) an elevated FSH level >25 IU/L on two occasions >4 weeks apart, or diagnosis of low ovarian reserve defined as: Basal FSH value >10 IU/L or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responders)
  • Normal karyotype 46, XX, and no known history FMR1 premutation (fragile X syndrome)
  • Baseline AMH levels ≤ 1.0 ng/mL
  • Presence of at least one ovary
Show all 13Show fewer
  • Normal uterine anatomy (by any clinically and/or imaging acceptable methods)
  • Normal thyroid function as evident by normal serum Thyroid Stimulating Hormone (TSH) levels
  • For subjects who had contraception before, the duration of amenorrhea should be more than 3 months after discontinuation of the oral contraception pill (OCP) or more than 6 months after discontinuation of Depo Provera (or similar) therapies
  • Agree to report any pregnancy to the research staff immediately
  • Willing and able to comply with study requirements and follow up instructions
  • Patient with known history of endometriosis or polycystic ovarian syndrome
  • If subject is planning to pursue pregnancy: presence of at least unilateral tubal patency (with any clinically acceptable methods)

Who cannot join

  • Currently pregnant or breast-feeding
  • Has a history of, or evidence of current gynecologic malignancy, breast cancer or other estrogen responsive cancer or any other malignancy within the past five years
  • Subjects with FMR1 premutation (fragile X syndrome), a BMP15 mutation or family history of a first degree relative with POI
  • Presence of adnexal masses indicating the need for further evaluation
  • Major mental health disorder that precludes participation in the study
  • Active substance abuse or dependence
Show all 28Show fewer
  • Current or recent (within the past 2 weeks) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestin, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. Washout will be allowed (2 weeks from screening)
  • Subjects under hormonal treatments including hormone replacement therapy (HRT) for osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology within 3 months from screening
  • Subjects with a history of breast cancer or other estrogen responsive cancer within 5 years from screening
  • Subjects with existing malignant neoplasm, under active management for malignant neoplasm or under active surveillance for malignant neoplasm within 5 years from screening
  • 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) as defined below:
  • Uncontrolled hypertension: Systolic BP ≥ 140 and/or Diastolic BP ≥90 in patients taking anti-hypertensive treatment
  • Kidney Disease: an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m^2 (Incase the result is above/below acceptable range, one repeat test is acceptable)
  • Liver Disease: Serum aminotransferase (ALT or AST) levels > 2x ULN
  • PCOS criteria: Oligo-anovulation (Irregular periods), antral follicle count (AFC) >12 measuring 2-9mm, hyperandrogenism (elevated testosterone and DHEA levels), clinical hirsutism
  • Subjects with untreated endocrinopathies including Cushing's disease, thyroid disease, congenital adrenal hyperplasia and hyperprolactinemia
  • Subjects with intra-uterine devices (IUDs)
  • Subjects who are allergic to low-molecular-weight heparin sodium or human albumin
  • Medical conditions that are contraindicated in pregnancy
  • Type I or Type II diabetes mellitus, or if receiving antidiabetic medications within 3 months from screening
  • Known anemia (Hemoglobin < 11 g/dL)
  • History of deep venous thrombosis, and/or pulmonary embolus
  • History of cerebrovascular disease
  • History of contrast media allergy
  • Known heart disease (New York Heart Association Class II or higher)
  • Known Liver disease (defined as Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >2 times normal, or total bilirubin >2.5mg/dL)
  • Known Renal disease (defined as Blood urea nitrogen (BUN) >30 mg/dL or serum creatinine > 1.6 mg/dL)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Optimal Health Associates

    Oklahoma City, Oklahoma, 73114

Other trials in United States

About this study

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 premature ovarian insufficiency (POI) and diminished ovarian reserve.

Read the detailed description

Premature ovarian insufficiency (POI) is a devastating disease for young women who have not yet completed childbearing. The prevalence of this condition is on the rise due to the increasing number of cancer survivors and the delay in childbearing age. Current treatment options available are very limited. Stem cell therapy has been shown to be beneficial and effective in various disease processes and the safety has been assessed in multiple clinical trials. The regenerative potential of mesenchymal stem cells is increasingly attributed to the paracrine effects of exosomes. Exosomes consist of bioactive lipids, nucleic acids, and proteins which play a key role in intercellular communication. Exosome therapy is considered a safe and effective therapy since it offers a cell-free approach. VL-PX10 is a decellularized exosome product derived from human placental derived mesenchymal stem cells.

This interventional pilot study will investigate the ability of intravenous injection of VL-PX10 to restore steroidogenesis, folliculogenesis, and support quality of life improvement, resumption of menstruation, and reversal of infertility in patients with POI and diminished ovarian reserve.

This is an open label study. All patients entering this study will be treated with VL-PX10. Participant duration will be approximately 12 months.

Being tested
VL-PX10
Medical subject headings
Primary Ovarian Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VL-PX10Drug

    VL-PX10 is a decellularized product consisting of proteins, lipids, and nucleic acids derived from human placenta mesenchymal stem cells.

Study groups in NCT06072794
Study groupRoleWhat they receive
Treatment ArmExperimentalNot described
Receives: Drug: VL-PX10

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events

    The number of treatment-emergent adverse events.

    Measured: 2 years

Secondary outcomes (4)

  1. Follicle Stimulating Hormone Levels

    50% reduction in follicle stimulating hormone values.

    Measured: 2 years

  2. Anti-Müllerian Hormone Levels

    30% increase in anti-Müllerian hormone levels.

    Measured: 2 years

  3. Estradiol Levels

    30% increase in estradiol levels.

    Measured: 2 years

  4. Antral Follicle Counts

    Increased antral follicle counts.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start6 Oct 2023
  3. Primary completionOct 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Why it stopped: Sponsor request

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a dose escalation study. The study participants are organized in groups of 3 where each participant will receive one study treatment.
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06072794
Sponsor's protocol ID
VL-POI-01
Acronym
VL-POI-01
Status last verified
Sep 2024
First submitted
20 Sep 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VL-PX10 in people with Premature Ovarian Insufficiency and Diminished Ovarian Reserve, run by Vitti Labs, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06072794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in