Cord Blood Serum Eye Drops: application of the collection circuit and of the qualification of donations

6 October 2021

Alessandra Hinic¹, Amélie Benin³, Coryne Hildebert³, Marion Jobard², Marie-Laure Brandely-Piat¹, Rui Batista^{1, 2}
1-Unité de Préparations Stériles Ophtalmologiques et Oncologiques, 2- Unité d’Assurance Qualité, Service de Pharmacie Clinique, 3- Service d’Obstétrique, GH Centre Université de Paris, AP-HP, Hôpital Cochin, 27 rue du faubourg St Jacques, 75014 Paris, France

Introduction
Cord Blood Serum Eye Drops are an alternative to autologous serum eye drops used in the treatment of atrophic keratitis. The richness in growth factors of cord blood serum (CBS) justifies its use. However, the implementation of its preparation by an hospital pharmacy is complex and is based on multidisciplinary collaboration. The objective of this work was to set up the collection of cord blood and to qualify these donations before their use.

Materials and methods
A literature research has been conducted to define the cord blood collecting conditions for this specific purpose. Exchanges with the Italian team of Bologna, referent in this field, helped to consolidate our project. A collaboration with the maternity of our hospital combining a chief resident and the staff manager of the delivery room has been set up. Finally, a multidisciplinary group of biologists has been consulted to validate serological research.

Results
Cord blood is collected after informed consent from the mother before delivery. Laboratory tests are performed on mother’s blood at 8 weeks gestation to check the absence of immune response to HIV, HCV, HBV, syphilis, rubella and toxoplasmosis. After delivery and before afterbirth, approximately 80 mL of cord blood are collected using a specific collection device (Biomed Device, Italy). Blood samples are also transferred in EDTA tubes. Cord blood is so clotted at room temperature for two hours and then the blood bag is centrifuged at 3 000 rpm for 15 minutes and placed 24/48 hours at +4°C on a suitable support to allow optimal separation of blood and serum. After coagulation, serum is transferred to a second bag in a closed system and some serum samples are collected in dry tubes. Tests are immediately performed to detect the presence of infective diseases: hepatitis B and C virus, human immunodeﬁciency virus, HIV/HBV/HCV-NAT, TPHA, CMV, HTL VI/II, HSV-1, HSV-2 and SARS-CoV2 genome detection. Specific dosages related to ophthalmic use are performed: vitamin A, EGF, VEGF, PDGF, FGF, NGF, TGF-α, TGF-β 1,2,3 and IL-13, IL-6, IL-10, IL-4, IL-1B.

Discussion - Conclusion
To date, 4 donations have been collected and made it possible to test in practice the collection and qualification procedures implemented. The collection material tested was appreciated by the health care team and allowed, on average, the collection of 10 mL of CB serum. This volume is expected to increase with more experience. All biological tests have been performed and collected. The dosage of the growth factors will be carried out in 1 time on the first 10 donations. The cost of all biological tests, estimated at €911 per donation, will have to be reflected on the price of eye drops.