Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cord Blood Serum in the Treatment of Ocular Surface Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01234623
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : May 26, 2011
Sponsor:
Information provided by:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Brief Summary:

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

Condition or disease Intervention/treatment
Graft vs Host Disease Sjogren's Disease Other: UCS eyedrops

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Phase. Cord Blood Serum in the Treatment of Ocular Surface Diseases
Study Start Date : February 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 Name: no brand names, serial or code numbers




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult outpatients suffering from ocular surface discomfort and recurrent or permanent corneal epithelial defects
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234623


Locations
Layout table for location information
Italy
Ophthalmology Unit, Dept.of Specialistic Surgery and Anesthesiological Sciences
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
Layout table for investigator information
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 of Results:
P. Versura, V. Profazio, L. Foroni, M. Buzzi, A. Stancari, EC Campos. Cord blood serum eye drops in the treatment of ocular surface diseases in GVHD patients. A pilot study. 6th International Conference on the Tear Film & Ocular Surface: Basic Science and Clinical Relevance, Florence , September 22-25, 2010 Abstract

Other Publications:
Buzzi M, Versura P, Vaselli C, Coslovi C, Terzi A, Bontadini A, Campos EC. Fattori di crescita epiteliali nel sangue cordonale. SIES 2008, Bari 24-26 settembre 2008, abstract

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Emilio C Campos, Head. Ophthalmology Unit
ClinicalTrials.gov Identifier: NCT01234623    
Other Study ID Numbers: EudraCT: 2008-005757-38
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: April 2011
Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Umbilical cord serum, eyedrops, GVHD, SS-I, corneal healing
Additional relevant MeSH terms:
Layout table for MeSH terms
Sjogren's Syndrome
Graft vs Host Disease
Immune System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Ophthalmic Solutions
Pharmaceutical Solutions