Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg®

NCT06869863 | Recruiting Phase 1 DMC

• 1 other identifier: MSU 001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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. The study was approved by the Ministry of Health of the Russian Federation. The study is planned to include men aged 21 to 60 years with severe spermatogenesis disorders manifested as severe oligoasthenoteratozoospermia (OAT), non-obstructive azoospermia, high sperm DNA fragmentation (30% and more) and faced with the inability to conceive, including with the help of assisted reproductive technologies within 12 months from the date of diagnosis The aim of the therapy is to improve the spermogram indicators in order to increase the chances of successful use of assisted reproductive technologies. The drug is injected once under the protein sheath of both testicles. Observation in 1 week after the drug administration is carried out in hospital. Follow-up is performed by outpatient visits to the research center. The clinical trial is planned to enroll at least 80 adult patients aged 21 to 60 years with severe spermatogenesis disorders The study will include 3 periods:Screening Period - Day -15...0. , Period of study drug administration and inpatient follow-up - Day 1 through Day 7., Follow-up period - through Day 90. The total duration of participation in the study, including the screening period and the follow-up period, will not exceed 119 days. After the end of the study period, the study will be followed up for 1 year to record delayed adverse events.

Conditions

Azoospermia, Nonobstructive; Teratospermia; Oligospermia; Men Infertility

Keywords

men infertility; azoospermia

Outcome Measures

Primary Outcomes (1)

• Semen Analysis

  In more than 30% of patients with nonobstructive azoospermia appearance of sperm cells in semen

  90 days

Secondary Outcomes (1)

• Increase in inhibin B level by more than 20% from baseline

  90 days

Study Arms (2)

MediReg

EXPERIMENTAL

60 patients (20 patients in first phase of the study and 60 patients in 2nd phase) a single injection of 0.5 ml of the investigational drug intratesticularly under the white membrane, alternately in both testicles

Biological: Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders

Clomiphene /Triovit,/Folic acid

ACTIVE COMPARATOR

Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months.

Other: Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months.

Interventions

Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders BIOLOGICAL

Human mesenchymal stromal cell secretion1 containing vascular endothelial growth factor (VEGF)2 ≥ 5,0 нг

MediReg

Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months. OTHER

Combination treatment recommended by standards

Clomiphene /Triovit,/Folic acid

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. Voluntarily signed Informed consent by the patient to participate in the clinical trial.
• \. 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.
• \. Patient willingness to follow all the requirements of the Protocol.

You may not qualify if:

• \. developmental anomalies of the genitourinary system (according to bladder and kidney ultrasound).
• \. surgical interventions on genitourinary organs in the history, except for surgical interventions associated with assisted reproductive technologies. 4.
• \. Systemic diseases requiring administration of corticosteroids, cytostatics, radiation therapy.
• \. Inflammatory diseases of the urinary and/or reproductive system. 6. Infectious diseases (including STDs) of the urinary and/or reproductive system.
• \. 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.).
• \. 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).
• \. Neurologic (Parkinson's disease) and/or psychiatric illnesses with a history or established by screening examination.
• \. Cancer with a history of cancer or as determined by screening examination (as determined by OBP and renal ultrasound, bladder ultrasound, prostate TRUS).
• \. 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.
• \. Severe somatic illnesses that, in the opinion of the investigator, may affect the patient's safety and ability to comply with the Protocol.
• \. A history of drug dependence. 19. Positive urinalysis for psychotropic and narcotic drugs, psychoactive medications.
• \. 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.
• \. Detection of alcohol vapor in breath 22. Participation in another clinical trial currently or in the previous 30 days prior to the screening visit.
• \. Patient's inability to understand or comply with study procedures or patient's refusal to cooperate with a particular investigator

Sponsors & Collaborators

• Lomonosov Moscow State University Medical Research and Educational Center: lead

Study Sites (1)

University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov

Moscow, Moscow, 119234, Russia

RECRUITING

MeSH Terms

Conditions

Azoospermia, Nonobstructive; Teratozoospermia; Oligospermia; Azoospermia

Interventions

Injections; Clomiphene

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Dmitry Okhobotov, doctor of sciences

  University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov, Moscow,

  PRINCIPAL INVESTIGATOR

• Anastasia Efimenko, doctor of sciences

  University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov, Moscow, Moscow 119234

  STUDY CHAIR

Central Study Contacts

Julia Begrambekova, Phd

CONTACT

+79854679273; julia.begrambekova@ossn.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, prospective, open-label, uncontrolled phase I/II study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of the medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection will be performed in patients with severe forms of spermatogenesis disorders manifested as severe oligoasthenoteratozoospermia (OAT), non-obstructive azoospermia, high sperm DNA fragmentation (30% and more). The absence of a comparison group is due to the fact that participation in the study carries a risk to patients that exceeds the minimum risk, Out of 60 patients, 20 subjects will be treated with MediReg® with evaluation of pharmacokinetics before and after drug administration. To confirm the non-randomization of the recorded changes, a control group receives therapy according to the approved recommendations, spermogram and hormonal profile assessment on days 0...90 is provided

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 11, 2025
• Study Start: November 26, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)