Stem Cells Therapy for Corneal Blindness (ExCell)
Primary Purpose
Corneal Injuries, Corneal Burns, Corneal Scars and Opacities
Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Ex-vivo cultivated limbal stem cell pool
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Injuries
Eligibility Criteria
Inclusion Criteria:
- Male and Female participants who are aged between 18-60 years.
- Patients who are having with unilateral blindness due to superficial (defined as involving the anterior 200 microns of the corneal stroma on ASOCT imaging) corneal wounds, ulcers, burns and scars.
- Eyes with otherwise normal.
Exclusion Criteria:
- Active infection, proven by microbiology.
- Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation.
- Children (<18 years of age).
- Inability/refusal to give written informed consent or to undergo any of the anterior segment imaging tests.
Sites / Locations
- LV Prasad Eye InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard Surgical therapy
Ex-vivo cultivated limbal stem cell pool
Arm Description
Includes the control group that fulfills the inclusion criteria
0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement.
Outcomes
Primary Outcome Measures
Ocular or systemic adverse effects
Secondary Outcome Measures
Visual improvement after treatment.
Checking for the improvement in visual acuity that will be calculated using LogMAR chart (where 20/20 vision is normal).
Full Information
NCT ID
NCT02948023
First Posted
October 20, 2016
Last Updated
March 3, 2018
Sponsor
L.V. Prasad Eye Institute
1. Study Identification
Unique Protocol Identification Number
NCT02948023
Brief Title
Stem Cells Therapy for Corneal Blindness
Acronym
ExCell
Official Title
Ex-vivo Cultivated Limbal Stem Cell Transplantation for Treatment of Superficial Corneal Pathologies
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2016 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
L.V. Prasad Eye Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a investigative initiated, comparative pilot clinical trial to ascertain the safety of application of ex-vivo cultivated limbal stem cells in human eyes for treating different superficial corneal pathologies. Pre-clinical work in murine models have already demonstrated efficacy of this technique in curing murine corneal pathologies.
Detailed Description
In this prospective interventional study patients with superficial corneal pathologies like scars, ulcers and burns will undergo a surgical procedure. Limbal ring from a cadaveric donor tissue, which is therapeutically accepted and serologically tested, is collected. This tissue will then be cultivated in the stem cell biology laboratory using standardized culture technique. Briefly the limbal tissue will be cut up into small pieces and digested overnight using an enzyme (Collagenase L). The cells obtained from the digest will be cultured on a petri-dish using 2% serum and growth factors. The cultured cells will be passaged three times to remove all epithelial cells from the culture. In the second procedure, the central corneal epithelium will be removed using a surgical sponge. 0.1ml of stromal cells in a concentration of 5x10^3 cells/uL diluted in the thrombin component of fibrin glue (TISEEL, Baxter) will be applied to the debrided corneal stroma. A soft bandage contact lens will be placed over the cornea at the end of the procedure. The patient will receive topical antibiotic and steroid eye drops in the post-operative period. Periodic comprehensive ophthalmic evaluation along with anterior segment optical coherence tomography (ASOCT) scanning and slit-lamp photography will be done at day 1, day 7, day 45 and day 90.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Injuries, Corneal Burns, Corneal Scars and Opacities
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Surgical therapy
Arm Type
No Intervention
Arm Description
Includes the control group that fulfills the inclusion criteria
Arm Title
Ex-vivo cultivated limbal stem cell pool
Arm Type
Active Comparator
Arm Description
0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement.
Intervention Type
Biological
Intervention Name(s)
Ex-vivo cultivated limbal stem cell pool
Intervention Description
0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement.
Primary Outcome Measure Information:
Title
Ocular or systemic adverse effects
Time Frame
until 3months after surgery
Secondary Outcome Measure Information:
Title
Visual improvement after treatment.
Description
Checking for the improvement in visual acuity that will be calculated using LogMAR chart (where 20/20 vision is normal).
Time Frame
until 3months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and Female participants who are aged between 18-60 years.
Patients who are having with unilateral blindness due to superficial (defined as involving the anterior 200 microns of the corneal stroma on ASOCT imaging) corneal wounds, ulcers, burns and scars.
Eyes with otherwise normal.
Exclusion Criteria:
Active infection, proven by microbiology.
Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation.
Children (<18 years of age).
Inability/refusal to give written informed consent or to undergo any of the anterior segment imaging tests.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sayan Basu, MBBS, MS
Phone
9140-30612625
Ext
2625
Email
sayanbasu@lvpei.org
First Name & Middle Initial & Last Name or Official Title & Degree
Vivek Singh, MSc PhD
Phone
9140-30612286
Ext
2286
Email
viveksingh@lvpei.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayan Basu, MBBS, MS
Organizational Affiliation
LV Prasad Eye Institiute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vivek Singh, MSc PhD
Organizational Affiliation
LV Prasad Eye Institiute
Official's Role
Principal Investigator
Facility Information:
Facility Name
LV Prasad Eye Institute
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sayan Basu, MBBS, MS
Phone
+9140 3061 2625
Ext
2625
Email
sayanbasu@lvpei.org
First Name & Middle Initial & Last Name & Degree
Vivek Singh Singh, MSc PhD
Phone
+9140 3061 2286
Ext
2286
Email
viveksingh@lvpei.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25504883
Citation
Basu S, Hertsenberg AJ, Funderburgh ML, Burrow MK, Mann MM, Du Y, Lathrop KL, Syed-Picard FN, Adams SM, Birk DE, Funderburgh JL. Human limbal biopsy-derived stromal stem cells prevent corneal scarring. Sci Transl Med. 2014 Dec 10;6(266):266ra172. doi: 10.1126/scitranslmed.3009644.
Results Reference
result
Citation
Basu S, Damala M, Singh V. Limbal Stromal Stem Cell Therapy for Acute and Chronic Superficial Corneal Pathologies: Early Clinical Outcomes of The Funderburgh Technique. Investigative Ophthalmology & Visual Science. 2017 Jun 23;58(8):3371-337
Results Reference
result
Learn more about this trial
Stem Cells Therapy for Corneal Blindness
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