A Phase 1/2 interventional study of Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders and 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. in Azoospermia, Nonobstructive, Teratospermia and Oligospermia, sponsored by Lomonosov Moscow State University Medical Research and Educational Center. Recruiting at 1 site in Russian Federation. Open to male participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Lomonosov Moscow State University Medical Research and Educational Center · Phase 1/2, Interventional, and Treatment
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.
23 studies on the registry are indexed under Azoospermia, Nonobstructive; 7 are open to participants now.
This study's planned enrollment of 80 is above the median of 61 across 12 interventional studies indexed under Azoospermia, Nonobstructive.
Browse Azoospermia, Nonobstructive studies →Lomonosov Moscow State University Medical Research and Educational Center is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
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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).
Exclusion Criteria:
Age younger than 21 and older than 60 years at the time of inclusion in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Human mesenchymal stromal cell secretion1 containing vascular endothelial growth factor (VEGF)2 ≥ 5,0 нг
Combination treatment recommended by standards
Semen Analysis
In more than 30% of patients with nonobstructive azoospermia appearance of sperm cells in semen
Time frame: 90 days
Increase in inhibin B level by more than 20% from baseline
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Dec 2025, 13 months after the start.
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Lomonosov Moscow State University Medical Research and Educational Center