The FDA has not approved a stem-cell therapy specifically for male infertility as a licensed product. Investigational testicular stem-cell or MSC protocols are registered with the NIH but remain unapproved. The EMA likewise has not granted a marketed male-infertility-specific stem-cell product. Assisted reproductive technology (IVF, ICSI) remains the FDA-established standard for male-factor infertility. Testosterone replacement, when indicated, is FDA-approved for hypogonadism but does not address underlying spermatogenic failure. Patients should distinguish investigational protocols from unproven fertility clinics offering direct-to-consumer stem-cell treatments.
Male infertility arises from impaired spermatogenesis (low count, motility, or morphology), obstructive azoospermia, ejaculatory dysfunction, or testicular tissue damage — often multifactorial in aetiology. Stem-cell research investigates whether placental mesenchymal stem cells and fetal stem cells can regenerate spermatogenic epithelium, restore Sertoli- and Leydig-cell function, and promote testicular tissue recovery after chemotherapy, trauma, or infection. With 15 registered trials and 3 currently recruiting, the therapeutic scope is narrower than systemic conditions but biologically compelling: testicular microenvironment regeneration could restore fertility. Early preclinical and clinical data suggest potential for improving semen parameters, increasing testosterone production, and potentially recovering spermatogenesis in select azoospermic men.
Съм ли кандидат? → · Male Infertility: full overview → · Цена Мъжко безплодие → · Cost →
Медицински преглед от редакционния екип на StemCellAtlas с Dr Dmytro Stoyanov (Urologist · 31+ yrs clinical practice) на партньорската клиника Stem Plus (София), спрямо ISSCR, FDA и EMA указания. Educational information, not medical advice; figures indicative.
GMP-сертифицирана регенеративна медицина в сърцето на ЕС — от 3 000–8 000 €, част от цените в САЩ или Германия. Персонализирани протоколи за пациенти от над 50 държави.
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