Limbus-derived Stem Cells for Prevention of Postoperative Corneal Haze
Pilot Clinical Trial to Assess the Safety of Limbus-derived Corneal Stem Cells in Prevention of Corneal Haze After Photo Therapeutic/Refractive Keratectomy (PTK/ PRK) and Collagen Cross Linking (CXL)
1 other identifier
interventional
15
1 country
1
Brief Summary
This is a investigator-initiated pilot clinical trial to ascertain the safety and efficacy of application of ex-vivo cultivated limbal stem cells in human eyes for treating Corneal Haze after Photo-Therapeutic/Refractive Keratectomy (PTK/ PRK) and Collagen Cross Linking (CXL). Instead of using adjunctive medical therapy like application of MMC (Mitomycin), a technique of cell delivery with fibrin sealant can be used. These cells are harvested from therapeutically accepted and serologically tested cadaveric corneas. The isolated limbal epithelial and mesenchymal or stromal cell suspension will then be cultured in CGMP laboratories and be tested for sterlity. These cells have also been shown to be effective in treating haze in laser refractive surgery in an animal model. Our initial experience of using these cells in a previous clinical trial showed that they were effective in preventing corneal haze in patients with burns and ulcers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 19, 2017
CompletedFirst Posted
Study publicly available on registry
September 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedFebruary 26, 2019
February 1, 2019
2.3 years
August 19, 2017
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maintenance of pre-operative best-spectacle corrected visual acuity
1 month
Secondary Outcomes (1)
Efficacy in reducing corneal light scatter using Scheimpflug imaging
1 month
Study Arms (2)
Standard Surgery with Vehicle
SHAM COMPARATORAfter the standard surgical procedure (PRK/PTK or CXL), patients will receive 50uL Fibrin Sealant (sham) without cells.
Standard Surgery with Stem Cells
EXPERIMENTALAfter the standard surgical procedure (PRK/PTK or CXL), patients will receive 50uL of a mixture of limbus derived corneal epithelial cells and limbus derived corneal stromal cells in a ratio of 2:1, at a concentration of 50000 cells/uL diluted in the thrombin component of Fibrin Sealant (TISEEL, Baxter).
Interventions
Mixture of limbus derived corneal epithelial cells and limbus derived corneal stromal cells in a ratio of 2:1, at a concentration of 50000 cells/uL diluted in fibrin sealant
50uL of commercially available fibrin sealant (Baxter, TISEEL)
Eligibility Criteria
You may qualify if:
- Adult patients between20 to 40 years of age
- Meeting standard selection criteria for bilateral PTK/PRK or CXL
- No systemic diseases
- Eligible to give informed consent
- No other ocular co-existing pathologies
You may not qualify if:
- Undergoing surgery in only one eye
- Grossly asymmetric pathology
- Refusal to give informed consent
- Not agreeable or uncooperative for corneal imaging
- Unlikely to come for follow-up for 1 month
- International and out-station patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LV Prasad Eye Institute
Hyderabad, Telangana, 500034, India
Related Publications (2)
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.
PMID: 25504883RESULTBasu 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
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sayan Basu, MBBS MS
LV Prasad Eye Institute
- PRINCIPAL INVESTIGATOR
Vivek Singh, MSc PhD
LV Prasad Eye Institute
- PRINCIPAL INVESTIGATOR
Jagadesh C Reddy, MBBS MD
LV Prasad Eye Institute
- PRINCIPAL INVESTIGATOR
Pratik Gogri, MBBS MS
LV Prasad Eye Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal Investigator
Study Record Dates
First Submitted
August 19, 2017
First Posted
September 27, 2017
Study Start
August 1, 2017
Primary Completion
December 1, 2019
Study Completion
June 1, 2020
Last Updated
February 26, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share