Ignite Creation Date:
2024-05-06 @ 8:01 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02649621
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2016-01-06
Brief Title:
The Improvement of Limbal Stem Cell Deficiency LSCD in Unilateral Stem Cell Damage by Amniotic Membrane Extract Eye Drop AMEED
Sponsor:
Royan Institute
Organization:
Royan Institute
Study Overview
Official Title:
The Effect of in Vivo Cultured Limbal Stem Cells in the Treatment of Unilateral Corneal Stem Cell Damage
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Corneal epithelial cells and limbal stem cells LSC are located in the limbus basal epithelium that are necessary for repair of corneal About patients with deficient or absence of this area has been proposed various treatments such as limbal stem cell transplantation
This study is a prospective clinical trial to compare the improvement of limbal stem cell deficiency LSCD in vivo by using of Amniotic Membrane Extract Eye Drop AMEED
This study is a prospective clinical trial to compare the improvement of limbal stem cell deficiency LSCD in vivo by using of Amniotic Membrane Extract Eye Drop AMEED
Detailed Description:
The cornea is the eye anterior portion which its refractive power and transparent is essential for normal vision
The damaged cornea surface can reduce vision and leads to blindness ultimately Corneal epithelial and some times limbal stem cell LSC are involved in corneal injuries Limbal stem cells LSC are necessary for repair and reconstruction of corneal that reduction of these cells occurs by various causes including congenital causes eye inflammatory diseases and burns For cornea stem cell damages or limbal stem cell deficiency LSCD cornea becomes conjunctivalization LSCD may involve one eye unilateral or two eyes bilateral
Due to autologous transplantation problems in patients with unilateral LSCD and recent successes to resolve this problem it seems that transplantation of cultured corneal stem cells on amniotic membrane is other way in treatment of unilateral LSCD It is called ex vivo
Amniotic membrane can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation angiogenesis and scarring It is well accepted that amniotic membrane transplantation AMT as a temporary patch normally dissolves within 2 weeks Consequent reapplication of membrane is difficult for the patient On the other hand in ex vivo corneal tissue from healthy eye must be transported to laboratory for cell culture on AM that is required equipment There is also a risk of cell infection and transmission that is very important issue However in infected cells re-biopsy of the healthy eye is required that is uncomfortable and difficult for the patient Other studies have been reported that amniotic membrane extract AME has same characteristics and features
We previously have reported an effective potential of AMEED in limbal stem cell proliferation in vitro and also rabbit corneal epithelium healing in vivo
This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop AMEED on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage
The damaged cornea surface can reduce vision and leads to blindness ultimately Corneal epithelial and some times limbal stem cell LSC are involved in corneal injuries Limbal stem cells LSC are necessary for repair and reconstruction of corneal that reduction of these cells occurs by various causes including congenital causes eye inflammatory diseases and burns For cornea stem cell damages or limbal stem cell deficiency LSCD cornea becomes conjunctivalization LSCD may involve one eye unilateral or two eyes bilateral
Due to autologous transplantation problems in patients with unilateral LSCD and recent successes to resolve this problem it seems that transplantation of cultured corneal stem cells on amniotic membrane is other way in treatment of unilateral LSCD It is called ex vivo
Amniotic membrane can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation angiogenesis and scarring It is well accepted that amniotic membrane transplantation AMT as a temporary patch normally dissolves within 2 weeks Consequent reapplication of membrane is difficult for the patient On the other hand in ex vivo corneal tissue from healthy eye must be transported to laboratory for cell culture on AM that is required equipment There is also a risk of cell infection and transmission that is very important issue However in infected cells re-biopsy of the healthy eye is required that is uncomfortable and difficult for the patient Other studies have been reported that amniotic membrane extract AME has same characteristics and features
We previously have reported an effective potential of AMEED in limbal stem cell proliferation in vitro and also rabbit corneal epithelium healing in vivo
This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop AMEED on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None