Compassionate use and hospital exemption for regenerative medicine: Something wrong to apply the program for patients in a real world

Abstract

“Compassionate use” or “Hospital exemption” provides an important pathway for patients with life-threatening conditions to gain access to unproved human cells and tissue products. In a real world, any practitioners may not comply with relevant system. Such regulation should establish an international registry of clinical practices of stem cell therapy as well as provide education for patients to prevent deception by the spread of misinformation by testimonials on websites. Keywords: Compassionate use, Hospital exemption, Expanded access, Regenerative medicine products, Advanced therapy medicinal products (ATMPs), Human cells, Tissues and cellular and tissue-based products (HCT/Ps), Stem cell products