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Limbus-derived Stem Cells for Prevention of Postoperative Corneal Haze

NCT03295292 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-02-26

No results posted yet for this study

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.

Conditions

  • Corneal Scars and Opacities

Interventions

BIOLOGICAL

Stem cells

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

OTHER

Vehicle

50uL of commercially available fibrin sealant (Baxter, TISEEL)

Sponsors & Collaborators

  • L.V. Prasad Eye Institute

    lead OTHER

Principal Investigators

  • Sayan Basu, MBBS MS · LV Prasad Eye Institute

  • Vivek Singh, MSc PhD · LV Prasad Eye Institute

  • Jagadesh C Reddy, MBBS MD · LV Prasad Eye Institute

  • Pratik Gogri, MBBS MS · LV Prasad Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-12-31
Completion
2020-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03295292 on ClinicalTrials.gov