Actively Recruiting
Open Single-center Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MediReg4 (Human Mesenchymal Stromal Cell Secretome) Injection in Men with Severe Spermatogenesis Disorders
Led by Lomonosov Moscow State University Medical Research and Educational Center · Updated on 2025-03-11
80
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment for men with severe infertility caused by problems with sperm production, including conditions like non-obstructive azoospermia and severe oligoasthenoteratozoospermia (OAT). This Phase I/II clinical trial aims to study the safety and effectiveness of MediReg4, an innovative drug made from human mesenchymal stromal cell secretions. The study is conducted at Lomonosov Moscow State University and approved by the Ministry of Health of the Russian Federation. It includes men aged 21 to 60 years who have struggled to conceive for at least 12 months despite treatments, including assisted reproductive technologies. The study involves two main treatment groups. One group receives a single injection of 0.5 ml MediReg4 under the membrane of both testicles alternately. Another group receives a combination of clomiphene (Clostilbegit) 50 mg daily, along with supplements Triovit and folic acid, each taken once daily for three months. The treatment period includes hospitalization for observation during the first week after injection and outpatient follow-up visits. The trial consists of three periods: a screening phase up to 15 days before treatment, a study drug administration and inpatient follow-up from day 1 to day 7, and a follow-up period lasting through day 90. Participants will undergo semen analyses at 90 days to measure sperm quality, which is the primary outcome of the study. Additional measures include tracking changes in hormone levels such as inhibin B. The total time involved in the study will not exceed 119 days, including screening and follow-up. After study completion, participants will be monitored for an additional year to observe any delayed side effects or adverse events. The study is randomized and participants receive either the investigational drug or the active comparator treatment under single-blind conditions.
CONDITIONS
Brief 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 study inclusion
- Persistent severe sperm production disorders, including severe oligoasthenoteratozoospermia (OAT), non-obstructive azoospermia, or high sperm DNA fragmentation (30% or more) for at least 12 months
- Inability to conceive despite treatment or assisted reproductive technologies for 12 months
- Voluntarily signed informed consent to participate
- Willingness of patients and their sexual partners to use reliable contraception during the study and for at least 1 month after
- Patient agrees to follow all study protocol requirements
You will not qualify if you...
- Age below 21 or above 60 years at the time of inclusion
- Developmental anomalies of the genitourinary system
- Previous genitourinary surgery except for assisted reproductive technology procedures
- Systemic diseases requiring corticosteroids, cytostatics, or radiation therapy
- Inflammatory or infectious diseases of the urinary or reproductive system
- Hereditary infertility factors, including Klinefelter syndrome, cystic fibrosis gene, Y-chromosome microdeletions, and other genetic syndromes
- Obstructive azoospermia
- Positive tests for HIV, hepatitis B or C, or syphilis
- Severe liver failure or active liver disease
- Kidney dysfunction with high serum creatinine
- Recent cardiovascular diseases such as heart attack or severe arrhythmia
- Neurologic or psychiatric illnesses
- History or presence of cancer
- Allergy to study drug components
- Severe mental illness or need for tranquilizers, neuroleptics, or antidepressants
- Severe somatic illnesses affecting safety or protocol compliance
- History of drug dependence or positive drug tests
- Alcohol intake over 10 units per week or history of alcoholism
- Alcohol presence in breath
- Participation in another clinical trial within 30 days
- Inability or refusal to comply with study procedures
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either a single intratesticular injection of MediReg® or daily oral tablets of clomiphene, Triovit, and folic acid for 3 months.
1 injection visit or daily oral treatment; follow-up visits during treatment may occur
Duration - Up to 90 days post-treatment
Participants are monitored for safety and efficacy outcomes including semen analysis and inhibin B levels.
Periodic visits during and after treatment to assess outcomes
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
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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