title: Animal models to assess the therapeutic efficacy of human serum and serum-converted platelet lysates for dry eye syndrome: Seeing is believing.
abstract: There is much interest in the clinical use of serum-converted human blood or platelet concentrates in regenerative medicine, most specifically for wound healing and tissue repair of soft and hard tissues. The scientific rationale supporting the clinical efficacy of these preparations is based on the expectation that their physiological mixture of natural growth factors can orchestrate cell expansion and differentiation in vivo. However, a lack of standardization and regulatory oversight of these blood materials maintain a perception of uncertainty in the scientific and medical community on the value of these preparations for some clinical indications. More studies are needed to understand the mechanism of action underlying their expected efficacy and standardize their use, and benefit from their biological versatility. One application of serum is as eye drop for treating dry eye syndrome (DES), a multifactorial disease of the ocular surface, which has a prevalence of 15% of more in the population. DES can lead to chronic inflammation of the ocular surface, surface impairment in the cornea and conjunctiva, and, in patients with Sjogren syndrome, result in a disruption of the ocular surface epithelium. Objective experimental assessment of safety and efficacy of serum eye drops can help establish scientific rationale in optimal product composition and use. This can be achieved, first, through cell cultures with relevant cell models, before considering, then, animal studies using DES animal models. Several models have been evaluated and are reported in this concise review. The model we have developed encompasses the use of rabbits, where their eyes are treated with 0.1% benzalkonium chloride (BAC), a common preservative in ophthalmic agents, 3 times daily for 4 weeks. This relatively mild treatment results in moderate DES pathology, with a stable shortage of tear secretion throughout a 7-week study period, which we found suitable for assessing efficacy of serum eye drops.
authors.affiliation: Graduate Institute of Biomedical Materials and Tissue Engineering, College of Biomedical Engineering, Taipei Medical University, Taiwan.
authors.forename: Ching-Li
authors.initials: CL
authors.lastname: Tseng
authors.affiliation: International Consultancy in Blood Components Quality/Safety Improvement, Audit/Inspection and DDR Strategy, London, UK. Electronic address: jseghatchian@btopenworld.com.
authors.forename: Jerard
authors.initials: J
authors.lastname: Seghatchian
authors.affiliation: Graduate Institute of Biomedical Materials and Tissue Engineering, College of Biomedical Engineering, Taipei Medical University, Taiwan. Electronic address: thburnouf@gmail.com.
authors.forename: Thierry
authors.initials: T
authors.lastname: Burnouf
mesh_terms: D000818:Animals; D001548:Benzalkonium Compounds / Q000633:toxicity*; D004195:Disease Models, Animal; D015352:Dry Eye Syndromes / Q000139:chemically induced / Q000188:drug therapy / Q000378:metabolism / Q000473:pathology; D006801:Humans; D009883:Ophthalmic Solutions / Q000737:chemistry / Q000627:therapeutic use; D011817:Rabbits; D044967:Serum / Q000737:chemistry*
chemical_list: D001548:Benzalkonium Compounds; D009883:Ophthalmic Solutions