Cord Blood Serum in the Treatment of Ocular Surface Diseases

May 25, 2011 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Pilot Phase. Cord Blood Serum in the Treatment of Ocular Surface Diseases

Human autologous serum (AS) eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing, due to their growth factor (GF) content. Umbilical cord serum (UCS) contains even higher GF concentrations and the objective of the study was to prove whether UCS eye drops

  1. are effective in the healing of corneal epithelial defects.
  2. ameliorate the painful subjective symptoms

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The regular collection and banking of cord blood remaining in the placenta after baby's delivery started in the early 1990s and was prompted by the observation that cord blood shows an immunological immaturity which allows to avoid any matching between donor-mother source and patient-recipient, it contains a number of haemopoietic progenitor and stem cells and is therefore potentially and safely useful in the field of regenerative medicine.

Cord blood collection occurs after the umbilical cord has been cut and is extracted from the fetal end of the cord. After collection, the cord blood unit bag is delivered to the lab, processed and then cryopreserved.

The main current clinical use of cord blood is allogeneic transplantation in patients suffering from severe blood diseases but physicians and researchers are making significant progresses evaluating the safety and efficacy of umbilical cord blood stem cells for therapeutic uses far beyond their uses for blood disorders.

Umbilical cord serum (UCS) contains many growth factors and especially EGF and TGF-beta1 concentrations are two-three times higher than in peripheral blood serum and much higher than in tears and is sufficient to prevent squamous metaplasia. In addition, UCS contains anti-inflammatory cytokines with protective effect.

Current therapy for SS-I and GVHD related dry eye depends upon clinical severity of the disease. From mild to progressively severe involvement of corneal epithelial damage , tear substitutes, FANS, steroids, Cyclosporin A, contact lens shields can be topically applied alone or in combination. Autologous serum eyedrops can be an option in severe cases as well, since it supplies epithelial growth factors to the healing process of epithelium.

The use of autologous serum eyedrops, however, is a controversial issues in diseases where inflammatory cytokines are present in peripheral blood, such as GVHD.

The use of cord blood serum based tear substitutes has been recently proposed in the literature for the treatment of ocular surface diseases and neurotrophic keratitis, because it contains growth factors, neurotrophic factors and essential components of tears. Moreover, serum from cord blood is readily available from cord blood banks as quality controlled product and is therefore theoretically attractive for topical use in ophthalmology.

The use of cord blood serum eyedrops as a biological preparation can display in itself efficacy features higher than the other drugs in terms of healing and anti-inflammatory properties in absence of any chemical compound.

In Italy biological products for topical use in ophthalmology to treat corneal epithelial severe defects are not available. The originality of the present study is based on the optimization and standardization of biological eyedrops prepared from cord blood serum. The efficacy and safety of the product for topical use in ocular surface diseases will be evaluated .

For the purpose, the following methods will be applied at baseline and endpoint (28 days of treatment with UCS eyedrops):

  1. Patients' subjective symptoms evaluation by a validated questionnaire for dry eye (OSDI)
  2. Slit Lamp examination and evaluation of Tear Film Break Up Time, corneal fluorescein staining score, conjunctival lissamine green staining score, staining will be recorded with digital photos to estimate the healing area in the follow up
  3. Schirmer I test to evaluate tear production
  4. Corneal sensitivity test (measured with a Cochet-Bonnet esthesiometer)
  5. Tear osmolarity, (TearLab, TearLab S.Diego) an indicator of the ability of the patient to compensate
  6. Tear Clearance Rate, a global indicator of tear production and tear evaporation
  7. Tear Proteomic to evaluate tear protein profile
  8. Corneal and Conjunctival inflammatory marker evaluation on cells collected by imprint and scraping cytology

Data will be statistically evaluated after 28 days treatment and matched vs baseline by using the descriptive statistics for paired data. Statistic outcomes will be analyzed with caution due to the non-randomized study design.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Ophthalmology Unit, Dept.of Specialistic Surgery and Anesthesiological Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult outpatients suffering from ocular surface discomfort and recurrent or permanent corneal epithelial defects

Description

Inclusion Criteria:

  • to suffer from GVHD after bone marrow transplantation or SS-I
  • presence of permanent or transient corneal epithelial defects scored > 2 , according to DEWS severity classification
  • to be in a general healthy condition
  • signature of study consent for participation and personal data treatment.

Exclusion Criteria:

  • to suffer from glaucoma and being under treatment with antiglaucomatous drugs
  • to have received refractive surgery over the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
UCB eyedrops, single arm
One-centre pilot study, open, non randomized.
Other: UCS eyedrops
1 ml UCS eyedrops/day topically applied 8 times/day 1 drop/eye for 28 days
Other Names:
  • no brand names, serial or code numbers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Corneal epithelial damage evaluated by fluorescein staining (micron meter squares) with digital photos
Time Frame: 28 days treatment
Digital photographs taken at the slit lamp will be evaluated by means of an Image Analyzer softare, to determine the area of corneal epithelial damage involved at a given stand point. Reduction of damaged area will be estimated in micron meter squares
28 days treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reduction the patients' painful subjective symptoms
Time Frame: 28 days treatment
Subjective symptoms will be evaluated by means of a validated Questionnaire (OSDI, Ocular Surface Disease Index) at the given stand points
28 days treatment
Reduction the patients' painful subjective symptoms
Time Frame: 15 days treatment
Subjective symptoms will be evaluated by means of a validated Questionnaire (OSDI, Ocular Surface Disease Index) at the given stand points
15 days treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Emilio C Campos, MD, Head of Ophthalmology Unit, Dept.of Specialistic Surgery and Anesthesiological Sciences, University of Bologna, Policlinico S. Orsola-Malpighi, Pad 1 Palagi, Via Palagi 9 -40138 Bologna Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EudraCT: 2008-005757-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings