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

NCT06072794 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: VL-POI-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Ovarian Insufficiency; Diminished Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  The number of treatment-emergent adverse events.

  2 years

Secondary Outcomes (4)

• Follicle Stimulating Hormone Levels

  2 years

• Anti-Müllerian Hormone Levels

  2 years

• Estradiol Levels

  2 years

• Antral Follicle Counts

  2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Drug: VL-PX10

Interventions

VL-PX10 DRUG

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: Females with premature ovarian insufficiency
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vitti Labs, LLC: lead

Study Sites (1)

Optimal Health Associates

Oklahoma City, Oklahoma, 73114, United States

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a dose escalation study. The study participants are organized in groups of 3 where each participant will receive one study treatment.

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 10, 2023
• Study Start: October 6, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)