Actively Recruiting
Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg®
Led by Lomonosov Moscow State University Medical Research and Educational Center · Updated on 2025-03-11
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 21 to 60 years at the time of inclusion
- Persistent severe disorders of spermatogenesis for at least 12 months, including severe oligoasthenoteratozoospermia (OAT), non-obstructive azoospermia, or high sperm DNA fragmentation (30% or more)
- Inability to conceive despite treatment, including assisted reproductive technologies, for at least 12 months or refusal to use assisted reproductive technologies
- Voluntarily signed informed consent to participate in the clinical trial
- Willingness of patients and their sexual partners to use reliable contraception (at least two methods including one barrier method) from consent signing until at least one month after study completion
- Willingness to follow all study protocol requirements
You will not qualify if you...
- Age younger than 21 or older than 60 years at inclusion
- Developmental anomalies of the genitourinary system
- History of surgical interventions on genitourinary organs, except those related to assisted reproductive technologies
- Systemic diseases requiring corticosteroids, cytostatics, or radiation therapy
- Inflammatory or infectious diseases of the urinary or reproductive system
- Hereditary infertility factors such as Klinefelter syndrome, cystic fibrosis gene carriers, Y-chromosome microdeletions, or syndromes causing severe infertility
- Obstructive azoospermia
- Positive tests for HIV, hepatitis B or C, or syphilis
- Severe liver failure or active liver disease with high transaminase levels
- Renal dysfunction with serum creatinine over 120 �b5mol/L
- Cardiovascular diseases within 6 months prior to inclusion
- Neurologic or psychiatric illnesses
- History or presence of cancer
- Hypersensitivity to study drug components
- Mental illness or need for tranquilizers, neuroleptics, or antidepressants during the study
- Severe somatic illnesses affecting safety or compliance
- History of drug dependence or positive drug tests
- Excessive alcohol use or history of alcoholism
- Participation in another clinical trial within 30 days prior to screening
- Inability to understand or comply with study procedures or refusal to cooperate
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov
Moscow, Moscow, Russia, 119234
Actively Recruiting
Research Team
J
Julia Begrambekova, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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