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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 26, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Azoospermia, NonobstructiveTeratospermiaOligospermiaMen 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

Trial Locations (1)

119234

RECRUITING

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

All Listed Sponsors
lead

Lomonosov Moscow State University Medical Research and Educational Center

OTHER