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
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Transfusion and Apheresis ScienceAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Model list of essential medicines.WHO, Geneva, Switzerland2019
- Reducing the risk of infection from plasma products: specific preventative strategies.Blood Rev. 2000; 14: 94-110
- Probable transmission of hepatitis E virus (HEV) via transfusion in the United States.Transfusion. 2019; 59: 1024-1034
- Hepatitis E virus: emerging from the shadows in developed countries.Transfus Apher Sci. 2016; 55: 271-274
- Current and emerging infectious risks of blood transfusions.Jama-J Am Med Assoc. 2003; 289: 959-962
- Ebola virus convalescent blood products: where we are now and where we may need to go.Transfus Apher Sci. 2014; 51: 120-125
- Modern plasma fractionation.Transfus Med Rev. 2007; 21: 101-117
- Contribution to safety of immunoglobulin and albumin from virus partitioning and inactivation by cold ethanol fractionation: a data collection from Plasma Protein Therapeutics Association member companies.Transfusion. 2011; 51: 1412-1430
- Human platelet lysate: Replacing fetal bovine serum as a gold standard for human cell propagation?.Biomaterials. 2016; 76: 371-387
- Human platelet lysate current standards and future developments.Transfusion. 2019; 59: 1407-1413
- Preparation, quality criteria, and properties of human blood platelet lysate supplements for ex vivo stem cell expansion.N Biotechnol. 2015; 32: 199-211
- International Forum on GMP-grade human platelet lysate for cell propagation: summary.Vox Sang. 2018; 113: 80-87
- International Forum on GMP-grade human platelet lysate for cell propagation.Vox Sang. 2018; 113: e1-e25
- Tailor-made purified human platelet lysate concentrated in neurotrophins for treatment of Parkinson’s disease.Biomaterials. 2017; 142: 77-89
- The effects of platelet lysate patches on the activity of tendon-derived cells.Acta Biomater. 2018; 68: 29-40
- The role of a platelet lysate-based compartmentalized system as a carrier of cells and platelet-origin cytokines for periodontal tissue regeneration.Tissue Eng Part A. 2016; 22: 1164-1175
- Platelet lysate-modified porous silicon microparticles for enhanced cell proliferation in wound healing applications.ACS Appl Mater Interfaces. 2016; 8: 988-996
- An injectable platelet lysate-hyaluronic acid hydrogel supports cellular activities and induces chondrogenesis of encapsulated mesenchymal stem cells.Acta Biomater. 2019; 83: 233-244
- Platelet lysate embedded scaffolds for skin regeneration.Expert Opin Drug Deliv. 2015; 12: 525-545
- Randomised double-blind placebo controlled trial of topical autologous platelet lysate in venous ulcer healing.Eur J Vasc Endovasc Surg. 2000; 20: 296-301
- Novel therapeutic approaches in utilizing platelet lysate in regenerative medicine: Are we ready for clinical use?.J Cell Physiol. 2019; 234: 17172-17186
- Ligament tissue engineering using a novel porous polycaprolactone fumarate scaffold and adipose tissue-derived mesenchymal stem cells grown in platelet lysate.Tissue Eng Part A. 2015; 21: 2703-2713
- Reflections on dry eye syndrome treatment: therapeutic role of blood products.Front Med (Lausanne). 2018; 5: 33
- Platelet-rich plasma, a source of autologous growth factors and biomimetic scaffold for peripheral nerve regeneration.Expert Opin Biol Ther. 2017; 17: 197-212
- Standardizing the freeze-thaw preparation of growth factors from platelet lysate.Transfusion. 2017; 57: 1058-1065
- Allogeneic platelet-rich plasma: At the dawn of an off-the-Shelf therapy?.Trends Biotechnol. 2017; 35: 91-93
- Production and quality requirements of human platelet lysate: a position statement from the working party on cellular therapies of the international society of blood transfusion.Trends Biotechnol. 2019; https://doi.org/10.1016/j.tibtech.2019.06.002
- Gaps in the knowledge of human platelet lysate as a cell culture supplement for cell therapy: a joint publication from the AABB and the International Society of Cell Therapy.Cytotherapy. 2019;
- 5.2.12. Raw materials of biological origin for the production of cell-based and gene therapy medicinal products - European Pharmacopoeia eu/en/ph-eur-9th-edition.Council of Europe, Strasbourg2016
- Spezifische Aspekte zur Virussicherheit von Produktionshilfsstoffen für somatische Zelltherapie-Arzneimittel.Bundesgesundheitsbl. 2015; 58: 1233-1238
- Expired pathogen inactivated platelet concentrates support differentiation and immunomodulation of mesenchymal stromal cells in culture.J Tissue Eng Regen Med. 2014; 8 (abstract): 374
- Culture of human cell lines by a pathogen-inactivated human platelet lysate.Cytotechnology. 2016; 68: 1185-1195
- Expired and pathogen-inactivated platelet concentrates support differentiation and immunomodulation of mesenchymal stromal cells in culture.Cell Transplant. 2015; 24: 1545-1554
- Pathogen reduction through additive-free short-wave UV light irradiation retains the optimal efficacy of human platelet lysate for the expansion of human bone marrow mesenchymal stem cells.PLoS One. 2017; 12e0181406
- A mathematical model for estimating residual transmission risk of occult hepatitis B virus infection with different blood safety scenarios.Transfusion. 2017; 57: 841-849
- European Medicine Agency - Guideline on plasma-derived medicinal products.2012 (Accessed 31 December 2018). London, UK
- Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products.2003 (Geneva)www.WHO.int/bloodproducts
- Recommendations for the production, quality control and regulation of plasma for fractionation.World Health Organization, Geneva2005
- Committee for Proprietary Medicinal Products note for guidance on plasma -derived medicinal products. CPMP/BWP/269/95 rev.4.2009
- Building blocks of the viral safety margins of industrial plasma products.Ann Blood. 2018; : 3
- The clinical and biological impact of new pathogen inactivation technologies on platelet concentrates.Blood Rev. 2014; 28: 235-241
- Blood-borne pathogens: a canadian blood services centre for innovation symposium.Transfus Med Rev. 2016; 30: 53-68
- Platelet concentrates: balancing between efficacy and safety?.Presse Medicale (Paris, France: 1983). 2016; 45: e289-98
- Pathogen reduction technologies.ISBT Sci Ser. 2014; 9: 44-50
- Development of blood transfusion product pathogen reduction treatments: a review of methods, current applications and demands.Transfus Apher Sci. 2015; 52: 19-34
- Special considerations for the use of pathogen reduced blood components in pediatric patients: an overview.Transfus Apher Sci. 2018; 57: 374-377
- Pathogen inactivation plays an irreplaceable role in safeguarding the safety of blood transfusion.J Antivir Antiretrovir. 2016; : 8
- Towards pathogen inactivation of red blood cells and whole blood targeting viral DNA/RNA: design, technologies, and future prospects for developing countries.Blood Transfus. 2017; 15: 512-521
- Riboflavin‐ultraviolet light pathogen reduction treatment does not impact the immunogenicity of murine red blood cells.Transfusion. 2015;
- Pathogen reduction technologies: the best solution for safer blood?.J Blood Disord Transfus. 2013; : 2012
- Riboflavin.Adv Nutr: Int Rev J. 2016; 7: 973-975
- US Food and Drug Administration Select Committee on GRAS Substances (SCOGS) Opinion: Riboflavin, Riboflavin-5′-phosphate.2015
- Tolerance of platelet concentrates treated with UVC-light only for pathogen reduction--a phase I clinical trial.Vox Sang. 2015; 109: 44-51
- Ultraviolet C light efficiently inactivates nonenveloped hepatitis A virus and feline calicivirus in platelet concentrates.Transfusion. 2018; 58: 2669-2674
- Pathogen inactivation technologies for cellular blood components: an update.Transfus Med Hemotherapy. 2014; 41: 309-325
- Inactivation of the human immunodeficiency virus type 1 (HIV-1) by ultraviolet and X irradiation.Radiat Res. 1992; 131: 169-176
- Hepatitis E transmission by transfusion of Intercept blood system-treated plasma.Blood. 2014; 123: 796-797
- Parvovirus B19 passive transmission by transfusion of intercept(R) blood system-treated platelet concentrate.Transfus Med Hemother. 2016; 43: 198-202
- Pathogen inactivation efficacy of Mirasol PRT System and Intercept Blood System for non-leucoreduced platelet-rich plasma-derived platelets suspended in plasma.Vox Sang. 2014; 107: 254-260
- Viral safety of solvent/detergent-treated plasma.Transfusion. 2000; 40: 84-90
- Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies.Transfusion. 2009; 49: 1931-1943
- Expansion of adipose tissue mesenchymal stromal progenitors in serum‐free medium supplemented with virally inactivated allogeneic human platelet lysate.Transfusion. 2011; 51: 770-778
- Comparison of human bone marrow stromal cells cultured in human platelet growth factors and fetal bovine serum.J Transl Med. 2018; 16: 65
- Viral inactivation of human platelet lysate by gamma irradiation preserves its optimal efficiency in the expansion of human bone marrow mesenchymal stromal cells.Transfusion. 2019; 59: 1069-1079
- A double-virally-inactivated (Intercept-solvent/detergent) human platelet lysate for in vitro expansion of human mesenchymal stromal cells.Transfusion. 2019;
- Prion removal capacity of plasma protein manufacturing processes: a data collection from PPTA member companies.Transfusion. 2013; 53: 1894-1905
- Creutzfeldt-Jakob disease and blood transfusion safety.Vox Sang. 2018; 113: 220-231
Article info
Publication history
Published online: October 31, 2019
Identification
Copyright
© 2019 Elsevier Ltd. All rights reserved.
