OPHTHALMIC COMPOSITIONS

Abstract

The present invention discloses novel ophthalmic preparations for the treatment of corneal pathologies comprising umbilical cord blood plasma.

Claims

1. A method for the treatment of corneal pathologies comprising the use of isolated umbilical cord blood plasma.

2. The method for the treatment of corneal pathologies according to claim 1, characterized by having a concentration of between about 0.20-0.40 ng/ml of EGF and preferably of about 0.30 ng/ml of EGF.

3. The method for the treatment of corneal pathologies according to claim 1 for the treatment in humans or in non-human mammals.

4. The method for the treatment of corneal pathologies according to claim 3, wherein said non-human mammals are selected in the group comprising cat, dog and horse.

5. The method for the treatment of corneal pathologies according to claim 4, wherein said corneal pathologies comprise: dry eye syndrome, the graft-versus-host disease (GVHD), lesions caused by chemical burns, neurotrophic keratitis, Sjogren's syndrome, systemic schlerosis, rheumatoid arthritis, autoimmunity.

6. An ophthalmic composition comprising umbilical cord blood plasma.

7. The ophthalmic composition comprising umbilical cord blood plasma according to claim 6 further comprising an anticoagulant agent.

8. The ophthalmic composition according to claim 7, wherein said anticoagulant agent is selected in the group comprising citrate, phosphate, dextrose or a mixture thereof.

9. The ophthalmic composition according to claim 7, wherein said anticoagulant agent has the following composition: TABLE-US-00003 Quantity (g per 100 ml of Component anticoagulant mixture) Sodium citrate di-hydrate 2.63 Sodium citrate hydrate 0.327 Monosodium di-hydrate phosphate 0.251 Dextrose monohydrate 2.55 Water for injection q.b. to 100 ml

10. The ophthalmic composition according to claim 8, wherein said anticoagulant agent is comprised in an amount of between about 10-60% (volume/volume) and preferably of 15 or 20 or 25 or 30 or 35 or 40 or 45 or 50 or 55% (volume/volume) and even more preferably of about 50% (volume/volume).

11. The ophthalmic composition according to claim 7, characterized by having a concentration of between about 0.10-0.20 ng/ml of EGF and preferably of about 0.15 ng/ml of EGF.

12. A method for the treatment of corneal pathologies comprising the use of the ophthalmic composition according to claim 7.

13. The method for the treatment of corneal pathologies according to claim 12 in humans or in non-human mammals.

14. The method for the treatment of corneal pathologies according to claim 13, wherein said non-human mammals are selected in the group comprising cat, dog and horse.

15. The method for the treatment of corneal pathologies according to claim 12, wherein said corneal pathologies comprise: dry eye syndrome, the graft-versus-host disease (GVHD), lesions caused by chemical burns, neurotrophic keratitis, Sjogren's syndrome, systemic sclerosis, rheumatoid arthritis, autoimmunity.

16. A method for preparing the ophthalmic composition according to claim 7, comprising the step of contacting an isolated sample of umbilical cord blood with an anticoagulant agent or a mixture of anticoagulant agents and the step of subjecting the obtained preparation to centrifugation.

17. The method for preparing the ophthalmic composition according to claim 16, wherein the centrifugation is performed at a rotational speed of between about 1500-2500 g, preferably of between about 1700-2300 g and even more preferably of between about 1900-2100 g, for a period of between about 10-20 minutes, preferably of between about 13-17 minutes and even more preferably of between about 14-16 minutes.

18. The method for preparing the ophthalmic composition according to claim 16, which is preceded by a preliminary step of centrifugation at a rotational speed of between about 100-400 g, preferably of between about 150-350 g and more preferably of between about 150-250 g, for a period of between about 5-20 minutes, preferably of between about 7-15 minutes and even more preferably of between about 9-11 minutes.

19. The method for preparing the ophthalmic composition according to claim 16, further comprising the step of diluting the final preparation to a concentration of about 0.10-0.20 ng/ml of EGF and preferably of about 0.15 ng/ml of EGF.

20. The method for preparing the ophthalmic composition according to claim 17, comprising before the centrifugation step or the preliminary centrifugation step, a step for the selection of the isolated samples of umbilical cord blood, which includes checking the total nucleated cell count as a proxy of the content of the haemopoietic stem cells count suitable for transplantation and optionally the testing for markers for syphilis, HIV, HCV, HBV, bacteria, fungi.

21-24. (canceled)

Description

EXAMPLE

Preparation of an Eye Formulation from Umbilical Cord Blood Plasma

[0061] A sample of human umbilical cord blood has been collected from a suitable donor into a bag containing the anticoagulant agent:

TABLE-US-00002 Quantity Component (g per 100 ml) Sodium citrate di-hydrate 2.63 Sodium citrate hydrate 0.327 Monosodium di-hydrate phosphate 0.251 Dextrose monohydrate 2.55 Water for injection q.b. to 100 ml

[0062] After checking that the presence of biological components is insufficient for haematopoietic transplantation, the sample has been subjected to a first centrifugation at low speed (220 g for 10 minutes).

[0063] The red blood cells have then been separated and the supernatant platelet-rich plasma has been subjected to a centrifugation step at high speed (2,000 g for 15 minutes).

[0064] The platelet-rich fraction has been separated and the concentration of EGF checked in the platelet-poor plasma fraction.

[0065] Dilution of the sample has then been performed to a final EGF concentration of 0.15 ng/ml.

[0066] Aliquots of 2 ml each have been prepared for use.

[0067] From the above description, the advantages of the proposed invention will be immediately evident.

[0068] In particular, umbilical cord blood plasma is a surprisingly superior biological source of growth factors, which contributes to an unexpected increase in the rate of healing.

[0069] In addition to that, collection of peripheral autologous blood from patients can thus be avoided.

[0070] Accordingly, many problems connected to the poor compliance from certain categories of patients is advantageously overcome.

[0071] As a further advantage of the present invention, the preparation of eye drops or other ophthalmic compositions from umbilical cord blood plasma is fully and better integrated within the daily procedures in hospitals.

[0072] In fact, the collected cord blood from donation can serve only to a limited extent for transplantation purposes, because in only 10% of the cases the amount of haemopoietic stem cells in the sample renders it suitable for the treatment of blood diseases.

[0073] It is therefore an important advantage of the presently disclosed invention, the possibility of using a product which would be otherwise discarded in 90% of the cases. As a further important aspect, the present invention does not require modification of the existing protocols for a separate collection of samples, that is on the other side required for collecting and handling serum samples.

[0074] In particular, there can be applied conditions comprising the use of known bags, which comprise anti-coagulant agents.

[0075] In addition, the method for obtaining the disclosed plasma sample can at the same time allow the preparation of cord blood platelet gel, which is a product that can be used for other useful purposes.

[0076] As above disclosed, the invention can find application for the treatment of pathologies both in the medical and in the veterinary field.