Blood Based Eyedrops From Different Sources in the Treatment of Severe

Status Recruiting

Clinical Trial Summary

Topical preparations (eye drops) derived from the blood have become a relatively common treatment for more advanced forms of keratopathy. The purpose of this study is to evaluate the effect of two blood components from donors (serum cord blood and serum from adult subject donor peripheral blood) in the treatment of severe keratopathies.

Clinical Trial Description

The rationale for the use of eye drops prepared from the blood as a source is mainly based on their content in growth factors (Growth factors, GF), which play an important role in regulation of many processes involved in normal healing of damaged corneal epithelium . The most used product so far is the eye drop prepared from serum (Autologous Serum, AS) or from platelet-rich plasma (Plasma Rich Platelet, PRP) of peripheral blood taken from the patients themselves. More recently, treatments were introduced by homologous sources that undoubtedly offer advantages as compared to autologous sources. In particular the homologous sources show:

- not invasiveness to the patient, who could in time not like the repeated withdrawals

- applicability even in patients with underlying systemic conditions. They may contain in their blood, among others, higher levels of pro-inflammatory factors, with the consequence of poor and inappropriate final product to be prepared and delivered to the eye

- reliability, since the homologous products can be prepared, controlled, also validated under the microbiological profile and standardized advance, then kept frozen until the dispensation

- conceptually unlimited availability of the product to be dispensed

- versatility of therapeutic indications, based on different GF levels which are estimated in advance

The purpose of this study is to evaluate the effect of two products derived from two different blood sources (cord blood collected at birth from placenta umbilical veins and adult subject donor peripheral blood) in the treatment of severe keratopathies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03064984
Study type	Interventional
Source	Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Contact	Emilio C Campos, MD
Phone	+39 051 2142831
Email	emilio.campos@unibo.it
Status	Recruiting
Phase	N/A
Start date	January 30, 2017
Completion date	September 30, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Blood Based Eyedrops From Different Sources in the Treatment of Severe Keratopathy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms