The regulatory clinical trial has commenced for “MediReg”®, an original domestically developed biologic drug based on the secretome of human mesenchymal stromal cells

Throughout life, the cellular components of tissues and organs require timely renewal and repair following significant damage. This function is carried out by stem cells, which in adult organisms are regulated by a specialized microenvironment known as the stem cell niche. Dysfunction of the niche can lead to loss of tissue integrity and impaired function. However, it has been demonstrated that the stem cell niche is capable of partial recovery. A significant contribution to this process is made by multipotent mesenchymal stem/stromal cells (MSCs), which are found in various tissue-specific stem cell niches, where they participate in maintaining and repairing damaged niches, presumably through the secretion of a wide range of factors collectively referred to as the secretome, which are involved in regulating tissue repair and regeneration. The use of the cell secretome, particularly that of MSCs, as regenerative medicine products underlies an emerging field of cell therapy known as “cell-free cell therapy”. Recently, the first regulatory clinical trial of an original biological drug, “MediReg”®, based on the secretome of human MSCs was initiated in the Russian Federation. Developed and manufactured at Lomonosov Moscow State University, this drug is intended to treat severe impairments of spermatogenesis by stimulating the recovery of the damaged spermatogonial stem cell niche. In this brief communication, using “MediReg”® as an example, we discuss the key aspects of the development and preclinical studies of biological drugs based on the secretome of human MSCs, as well as the prospects for their translation into clinical practice.