Treatment for severe male infertility using MediReg®
Open Single-center Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg® (Human Mesenchymal Stromal Cell Secretome), Lyophilizate for Preparation of Solution for Injection in Patients with Severe Spermatogenesis Disorders
This study is testing a new treatment called MediReg® to see if it can help men with severe infertility issues improve their sperm quality and increase their chances of conceiving.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | Male |
| Sponsor | Lomonosov Moscow State University Medical Research and Educational Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Moscow, Moscow) |
| Trial ID | NCT06869863 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MediReg®, a medicinal product derived from human mesenchymal stromal cell secretome, in men suffering from severe forms of male infertility, including azoospermia and severe oligoasthenoteratozoospermia. The trial is conducted in phases I and II at Lomonosov Moscow State University, targeting men aged 21 to 60 who have been unable to conceive for at least 12 months. Participants will receive MediReg® along with Clostilbegit, Triovit, and folic acid over a three-month period to assess improvements in sperm quality.
Who should consider this trial
Good fit: Ideal candidates are men aged 21 to 60 with severe spermatogenesis disorders and a history of infertility lasting over 12 months.
Not a fit: Patients with infertility not related to severe spermatogenesis disorders or those who have already achieved successful conception may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve fertility outcomes for men with severe infertility issues.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using cell secretome therapies for fertility issues, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 sperm DNA fragmentation (30% or more), including those caused by secretory infertility according to dynamic control of spermogram (at least 12 months from the moment of inclusion in the study).
* "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, with the proportion of normal sperm \<1% according to the dynamic control of spermogram (at least 12 months from the moment of inclusion in the study).
3\. inability to conceive against the background of "severe forms" of male infertility, not amenable to treatment, including assisted reproductive technologies, within 12 months from the moment of diagnosis or refusal to use assisted reproductive technologies.
4\. Voluntarily signed Informed consent by the patient to participate in the clinical trial.
5\. Willingness of patients and their sexual partners to use reliable contraceptive methods (combination of at least 2 methods, including 1 barrier method, e.g., use of spermicide and condom) from the time of signing the informed consent until at least 1 month after completion of study participation.
6\. Patient willingness to follow all the requirements of the Protocol.
Exclusion Criteria:
* 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 variants), autosomal defects with severe phenotypic abnormalities and infertility (Prader-Willi, Bardet-Biedl, Noonan syndromes, myotonic dystrophy, dominant polycystic kidney disease, 5-alpha-reductase enzyme deficiency, etc.). д.).
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 times the upper limit of the local laboratory norm).
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 ventricular arrhythmia, heart failure (NYHA class II-IV).
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
Where this trial is running
Moscow, Moscow
- University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov — Moscow, Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Dmitry Okhobotov, doctor of sciences — University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov, Moscow,
- Study coordinator: Julia Begrambekova, Phd
- Email: julia.begrambekova@ossn.ru
- Phone: +79854679273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.