Evaluation of the therapeutic effect of cellular fibrin membrane with autologous oral mucosal epithelial cells in the repair of chemical burns on the surface of the human eye - Phase 1 and 2 clinical trial
Investigation therapeutic effect of cellular fibrin membrane with autologous cells of the oral mucosa in the repair of chemical burns on the surface of the human eye - Phase 1 and 2 clinical trial
Design
Clinical trial without control group, community based, not blinded, Non-randomised controlled study
Settings and conduct
This study is related to ophthalmology field and will be done in Shafa hospital and Cell Therapy and Regenerative medicine Comprehensive Center of Kerman University of Medical Science. After case selection by physician, sample of patient's oral mucosa is prepared. After the preparation of cellular fibrin membrane with epithelial cells, the membrane is transplanted to patient's eye by physician. The patients will be follow up 7 and 28 days after transplantation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adults aged between 18-40 years Patients with severe corneal epithelium defect Patients with favorable prognostic factors Patients with normal intraocular pressure Patients with normal light perception that shows the health of nerve of eye Patients with no retina disease Patient with no severe dry eye Exclusion Criteria: Patients with severe systemic disorders Patients with mental disorders Pregnant women
Intervention groups
Cellular fibrin membrane with epithelial oral mucosa cells is prepared and then transplanted to patient's eye. Patients will be evaluated 7 and 28 days after transplantation.
Main outcome variables
Increase in transparency of the cornea, Increase corneal smooth surface, no evidence of vascularization in cornea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140911019125N9
Registration date:2020-10-11, 1399/07/20
Registration timing:prospective
Last update:2020-10-11, 1399/07/20
Update count:0
Registration date
2020-10-11, 1399/07/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32 24618
Email address
afarsinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of cellular fibrin membrane with autologous oral mucosal epithelial cells in the repair of chemical burns on the surface of the human eye - Phase 1 and 2 clinical trial
Public title
Treatment of ocular chemical burns with cellular fibrin membrane
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aged between 18-40 years
Patients with severe corneal epithelium defect
Patients with favorable prognostic factors
Patients with normal intraocular pressure
Patients with normal light perception that shows the health of nerve of eye
Patients with no retina disease
Patient with no severe dry eye
Exclusion criteria:
Patients with severe systemic disorders
Patients with mental disorders
Pregnant women
Age
From 18 years old to 40 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Kerman University Of Medical Science
Street address
Haft Bagh Blvd, Kerman University Of Medical Science
City
Kerman
Province
Kerman
Postal code
7616911333
Approval date
2020-10-05, 1399/07/14
Ethics committee reference number
IR.KMU.REC.1399.411
Health conditions studied
1
Description of health condition studied
Treatment of ocular chemical burns
ICD-10 code
S05.9
ICD-10 code description
Unspecified injury of eye and orbit
Primary outcomes
1
Description
Transparency of the cornea
Timepoint
Before intervention and 7 and 28 days after intervention
Method of measurement
Microscopic measurement
2
Description
Corneal smooth surface
Timepoint
Before intervention and 7 and 28 days after intervention
Method of measurement
Microscopic measurement
3
Description
Vascularization in cornea
Timepoint
Before intervention and 7 and 28 days after intervention
Method of measurement
Microscopic measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, after sampling from patients oral mucosa epithelial cells are extracted, fibrin membrane is prepared and coated with cells and then transplanted on eye surface of patients.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman, Shafa hospital
Full name of responsible person
Majid Shams
Street address
Kowsar Blvd, Shafa Hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
shamsoph@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Haft bagh Blvd. kerman university of medical science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft bagh Blvd, kerman university of medical science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft Bagh Blvd,Kerman University Of Medical Science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Fax
Email
afarsinejad@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Haft-Bagh Blvd, Kerman University Of Medical Science
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no additional data.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In our study non of the personal data of patients will be shared. Only data that are related to outcomes of intervention will be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
The data will be available for people working in academic institutions and clinicians.
Under which criteria data/document could be used
Applicants are only allowed to use received data in clinical and they are not allowed to published them.
From where data/document is obtainable
1- Phone: 034-31325374 2- e-mail: afarsinejad@kmu.ac.ir 3- Fax: 034-31325375 4- address: Haft bagh Blvd, Kerman university of medical science Dr. Alireza Farsinejad
What processes are involved for a request to access data/document
Applicant can receive information after contact and send e-mail up to 10 days.