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

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

Interventions

BIOLOGICAL

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

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

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.

Combination treatment recommended by standards

Sponsors & Collaborators

• Lomonosov Moscow State University Medical Research and Educational Center

  lead OTHER

Principal Investigators

• Dmitry Okhobotov, doctor of sciences · University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov, Moscow,

• 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 Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-26

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Russia

Study Locations