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

Thierry Burnouf; Lassina Barro; Ouada Nebie; Yu-Wen Wu; Hadi Goubran; Folke Knutson; Jerard Seghatchian

doi:10.1016/j.transci.2019.102674

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

Transfus Apher Sci. 2019 Dec;58(6):102674. doi: 10.1016/j.transci.2019.102674. Epub 2019 Oct 31.

Authors

Thierry Burnouf¹, Lassina Barro², Ouada Nebie³, Yu-Wen Wu³, Hadi Goubran⁴, Folke Knutson⁵, Jerard Seghatchian⁶

Affiliations

¹ Graduate Institute of Biomedical Materials and Tissue Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan; International PhD Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan; Research Center of Biomedical Devices, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan; International PhD Program in Cell Therapy and Regeneration Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: thburnouf@gmail.com.
² International PhD Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan.
³ Graduate Institute of Biomedical Materials and Tissue Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan.
⁴ Saskatoon Cancer Centre, Division of Oncology, College of Medicine, University of Saskatchewan, Canada.
⁵ Clinical Immunology and Transfusion Medicine IGP, Uppsala University, Uppsala, Sweden.
⁶ International Consultancy in Blood Components Quality/Safety Improvement, Audit/Inspection and DDR Strategies, London, UK.

PMID: 31735652
DOI: 10.1016/j.transci.2019.102674

Abstract

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.

Keywords: HPL; Human platelet lysate; Safety; Virus.

Publication types

Review

MeSH terms

Blood Platelets / virology*
Cell- and Tissue-Based Therapy*
Humans
Prions / physiology
Regenerative Medicine*
Risk Factors
Safety*

Substances

Prions