Viral safety of human platelet lysate for cell therapy and regenerative medicine: Moving forward, yes, but without forgetting the past

摘要

Growth factor-rich pooled human platelet lysate (HPL), made from human platelet concentrates, is one new blood-derived bioproduct that is attracting justified interest as a xeno-free supplement of growth media for human cell propagation for cell therapy. HPL can also find potentially relevant applications in the field of regenerative medicine. Therefore, the therapeutic applications of HPL go far beyond the standard clinical applications of the traditional blood products typically used in patients suffering from life-threatening congenital or acquired deficiencies in cellular components or proteins due to severe genetic diseases or trauma. A wider population of patients, suffering from various pathologies than has traditionally been the case, is thus, now susceptible to receiving a human blood-derived product. These patients would, therefore, be exposed to the possible, but avoidable, side effects of blood products, including transfusion-transmitted infections, most specifically virus transmissions. Unfortunately, not all manufacturers, suppliers, and users of HPL may have a strong background in the blood product industry. As such, they may not be fully aware of the various building blocks that should contribute to the viral safety of HPL as is already the case for any licensed blood products. The purpose of this manuscript is to reemphasize all the measures, including in regulatory aspects, capable of assuring that HPL exhibits a sufficient pathogen safety margin, especially when made from large pools of human platelet concentrates. It is vital to remember the past to avoid that the mistakes, which happened 30 to 40 years ago and led to the contamination of many blood recipients, be repeated due to negligence or ignorance of the facts.