Table 3.

Possible regulatory pathways to maintain use of cell therapies in University Hospitals and Burn Centers for hospitalized patients

Regulatory Pathway	Discussion	Responsibility Bearing
ATMP-drug type dossier submission	Extremely costly and stringent regulatory requirements Requires subcontracting to CMO Mitigated interest by pharmaceutical industry	Clinician Manufacturer
Compassionate use (Helsinki declaration)	Ethically justified from a clinical point of view but brings legal exposure regarding local regulations	Clinician Institution (hospital)
Hospital exemptions	Restricted to products not intended to be marketed, prepared on a nonroutine basis, in a nonindustrial manner, and used as custom-made products for individual patients	Clinician Institution (hospital)
Orphan drugs	Produced for diagnosis, prevention, or treatment of a life-threatening disease or potential chronic disability, which affects less than 5 of 10,000 people at a given time	Clinician Manufacturer
Hospital Magistral Preparations	Products manufactured, on demand or serially, by an authorized pharmacy following a medical prescription and intended for the treatment of a determined patient or subset of patients	Clinician Pharmacist
Hospital officinal preparations	Products manufactured, on demand or serially, by an authorized pharmacy following a recognized formula or monograph and to be used for treatment of the institution’s own patients	Clinician Pharmacist

ATMP, Advanced Therapy Medicinal Product; CMO, Contract Manufacturing Organization.