A Phase 1 interventional study of Ex-vivo cultivated limbal stem cell pool in Corneal Injuries, Corneal Burns and Corneal Scars and Opacities, sponsored by L.V. Prasad Eye Institute. Status unknown at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-06.
Sponsored by L.V. Prasad Eye Institute · Phase 1, Interventional, and Treatment
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.
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.
32 studies on the registry are indexed under Corneal Injuries; 9 are open to participants now.
This study's planned enrollment of 100 is above the median of 37 across 24 interventional studies indexed under Corneal Injuries.
Browse Corneal Injuries studies →L.V. Prasad Eye Institute is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: Ex-vivo cultivated limbal stem cell pool
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.
Ocular or systemic adverse effects
Time frame: until 3months after surgery
Visual improvement after treatment.
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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L.V. Prasad Eye Institute