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Tests treatment safety and results for Azoospermia, Nonobstructive
Official title Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg®
ClinicalTrials.gov ID: NCT06869863
What this study is testing
What is Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders?
Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for azoospermia, nonobstructive.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is open to patients with severe forms of male infertility (non-obstructive disorders of spermatogenesis, including azoospermia). The Phase I/II clinical trial is being conducted at the Lomonosov Moscow State University and is aimed at studying the efficacy and safety of the innovative drug "MediReg® (Human Mesenchymal Stromal Cell Secretome)", lyophilizate for preparation of solution for injection, 1.0 ml/dose for treatment of male infertility.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 60, men only
You may be able to join if
- 1\. Male patients aged 21-60 years at the time of inclusion in the study. 2. Persistent severe disorders of spermatogenesis, manifested as severe...
- "Persistent severe OAT" should be considered as disorders when sperm concentration \<5 million/mL, progressively motile sperm \<13% and/or total...
You likely can't join if
- 1\. Age younger than 21 and older than 60 years at the time of inclusion in the study.
- 2\. developmental anomalies of the genitourinary system (according to bladder and kidney ultrasound).
- 3\. surgical interventions on genitourinary organs in the history, except for surgical interventions associated with assisted reproductive...
- 4\. Systemic diseases requiring administration of corticosteroids, cytostatics, radiation therapy.
- 5\. Inflammatory diseases of the urinary and/or reproductive system. 6. Infectious diseases (including STDs) of the urinary and/or reproductive...
- 7\. Hereditary factors of infertility: (Klinefelter syndrome (all variants), autosomal abnormalities (all variants), carrying the cystic fibrosis...
See the full eligibility criteria
- 1\. Male patients aged 21-60 years at the time of inclusion in the study. 2. Persistent severe disorders of spermatogenesis, manifested as severe oligoasthenoteratozoospermia (OAT)\ , non-obstructive azoospermia, high...
- "Persistent severe OAT" should be considered as disorders when sperm concentration \<5 million/mL, progressively motile sperm \<13% and/or total number of progressively motile sperm in the ejaculate (PMPM) \<5 million...
- 1\. Age younger than 21 and older than 60 years at the time of inclusion in the study.
- 2\. developmental anomalies of the genitourinary system (according to bladder and kidney ultrasound).
- 3\. surgical interventions on genitourinary organs in the history, except for surgical interventions associated with assisted reproductive technologies. 4.
- 4\. Systemic diseases requiring administration of corticosteroids, cytostatics, radiation therapy.
- 5\. Inflammatory diseases of the urinary and/or reproductive system. 6. Infectious diseases (including STDs) of the urinary and/or reproductive system.
- 7\. Hereditary factors of infertility: (Klinefelter syndrome (all variants), autosomal abnormalities (all variants), carrying the cystic fibrosis gene (all variants), presence of Y-chromosome microdeletions (all AZF...
- 8\. Obstructive azoospermia by history or established by screening examination. 9. Positive test for HIV, hepatitis B and C, syphilis. 10. Severe liver failure or active liver disease (transaminase activity exceeding 5...
- 11\. Renal dysfunction with serum creatinine levels exceeding 120 µmol/L. 12. Cardiovascular diseases in the history within 6 months before inclusion in the study, such as myocardial infarction, angina pectoris, severe...
- 13\. Neurologic (Parkinson's disease) and/or psychiatric illnesses with a history or established by screening examination.
- 14\. Cancer with a history of cancer or as determined by screening examination (as determined by OBP and renal ultrasound, bladder ultrasound, prostate TRUS).
- 15\. Hypersensitivity to any of the components of the study drug in the history. 16. Mental illness, severe cognitive impairment, need to take tranquilizers, neuroleptics and/or antidepressants during this study.
- 17\. Severe somatic illnesses that, in the opinion of the investigator, may affect the patient's safety and ability to comply with the Protocol.
- 18\. A history of drug dependence. 19. Positive urinalysis for psychotropic and narcotic drugs, psychoactive medications.
- 20\. Intake of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to 1⁄2 liter of beer, 200 ml of wine, or 50 ml of alcohol) or a history of alcoholism.
- 21\. Detection of alcohol vapor in breath 22. Participation in another clinical trial currently or in the previous 30 days prior to the screening visit.
- 23\. Patient's inability to understand or comply with study procedures or patient's refusal to cooperate with a particular investigator
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Moscow, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 21 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.