Pterygium surgery by using autologous conjunctival cells transplantation implanted on human amniotic membrane
Design
Clinical trial without control group with sample size of 30 patients
Settings and conduct
We get a 1&2 mm from inferior fornix two weeks before surgery. After detachment and removal of the tenon capsule, the epithelial layer will be referred to the culture laboratory. After chopping the sample, we will put the segments on the amniotic membrane (on the basement membrane) and located in serumless keratinocyte growth culture media. After expansion, the implant will be kept secured in a place of bare sclera by nylon 10-0 sutures.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the presence of primary pterygium.
Exclusion Criteria: Recurrent pterygium; history of pterygium surgery.
Intervention groups
Patients with primary pterygium who are candidates for doing pterygium surgery underwent getting a sample of conjunctiva from inferior fornix. This sample will be sent to a laboratory for cellular expansion. If the cells grow efficiently after two weeks, we will have transplanted them after doing pterygium surgery. After transplantation, epithelialization of the conjunctiva and recurrence of pterygium will be evaluated in different follow-up times.
Main outcome variables
Expression of the epithelium;
Evaluation of the amount of collagen;
Evaluation of the epithelialization;
Evaluation of the recurrence;
Evaluation of the inflammation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210513051283N1
Registration date:2021-08-15, 1400/05/24
Registration timing:prospective
Last update:2021-08-15, 1400/05/24
Update count:0
Registration date
2021-08-15, 1400/05/24
Registrant information
Name
Hossein َAghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9162
Email address
aghaei.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
2021-09-23, 1400/07/01
Actual recruitment end date
2022-03-20, 1400/12/29
Trial completion date
2022-03-20, 1400/12/29
Scientific title
Pterygium surgery by using autologous conjunctival cells transplantation implanted on human amniotic membrane
Public title
Evaluation of the expanded conjunctiva in pterygium surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
presence the primary pterygium
Exclusion criteria:
ِDissatisfaction patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
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 Iran University of Medical Sciences
Street address
Hemmat Highway near to Milad Tower Iran University of medical Sciences
City
Tehran
Province
Tehran
Postal code
99-2-86-19057
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.IUMS.REC.1400.118
Health conditions studied
1
Description of health condition studied
primary pterygium-
ICD-10 code
H11.0
ICD-10 code description
Pterygium of eye
Primary outcomes
1
Description
Evaluation of re-epithelialization of cultivated tissue
Timepoint
Before conjunctival transplantation
Method of measurement
Hematoxilin-eosin staining
2
Description
Evaluation of collagenesis
Timepoint
Before conjunctival transplantation
Method of measurement
Trichrome-mason staining
3
Description
Evaluation of re-epithelialization and collagenesis of cultivated tissue
Timepoint
Before conjunctival transplantation
Method of measurement
Expression of integrin B 1,MUC4,CX43,Oct4,p63,CK19,CK13,CK12,CK3 by RT-PCR
4
Description
Healing process of transplanted conjunctiva
Timepoint
Day 1,3,7 and months 1,3,6,12
Method of measurement
Examination and Fluorescin staining
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We will get a sample of conjuctiva, 2x1 mm, from inferior fornix of the eye with pterygium two weeks before operation. After isolation the epithelium from tenon layer, the sample will be sent to laboratory. In laboratory this sample will be chopped and implanted over amniotic membrane (epithelial side). Then, this complex will be put in an acellular culture media, keratonocyte growth media, that consists of 10 ng/ml human epidermal growth factor (Gibco) ،5 _g/ml insulin (Sigma) ،0.5 _g/ml hydrocortisone (Sigma) 30 _g/ml bovine pituitary extract (Sigma) ،50 _g/ml Gentamicin (Gibco) ،50 ng/ml Amphotericin B (Gibco). Calcium concentration is 15/0 Millimol in culture media. Adhesion and proliferation of cells will increase by increasing the calcium concentration to 9/0 Mm. The chopped sample and 500 micro- liters culture media will have cultured in an incubator of 37 centigrade temperature, 5/5 % Co2 and 95% humidity for one to two weeks. the culture media will change every two to three days and at each change cells will evaluate by microscope. we will use of more amount of culture media by adhesion the cells to amniotic membrane. We evaluate the cells based on rate of cells growth and adhesion to amniotic membrane every day. In addition, cells growth is visible by color change of culture media. After ending the cultivation and proliferation of cells on amniotic membrane, the complex will put up in a new culture media that consists of Dulbecco’s Modified Eagle’s Medium (DMEM) and Ham’s F12 media (Gibco), supplemented with 2.5% fetal bovine serum (Hyclone, Logan, Utah), 10 ng/ml human epidermal growth factor, 5 _g/ml insulin, 0.4 _g/ml hydrocortisone, 8.4 ng/ml cholera toxin (Sigma), 50 _g/ml streptomycin (Gibco), and 50 IU/ml penicillin (Gibco) for three days.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rassoul Akram Hospital
Full name of responsible person
Hossein Aghaei
Street address
Niayesh Avenu, Satar Khan Street Rassoul Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9162
Fax
+98 21 6650 9162
Email
aghaei.h@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevallian
Street address
Hemmat highway, near to Milad Tower,Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hossein Aghaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Rassoul Akram Hospital, Niyayesh avenue satarkhan street Tehran Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9162
Fax
+98 21 6650 3131
Email
aghaei.h@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Aghaei
Position
Associate Prefessor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Rassoul Akram Hospital, Niyayesh avenue Sattarkhan street Tehran Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9162
Fax
+98 21 6650 9162
Email
aghaei.h@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Aghaei
Position
Associate Professor, faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Niyayesh avenue Sattarkhan street Rassoul Akram Hospital Eye Research Center
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Fax
+98 21 8866 5511
Email
aghaei.h@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available