UnknownPhase 1

Stem Cells Therapy for Corneal Blindness

India100 participantsStarted 2016-08-31

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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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.

What they're measuring

Ocular or systemic adverse effects

Timeframe: until 3months after surgery

Trial details

NCT IDNCT02948023

SponsorL.V. Prasad Eye Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02

Contact for this trial

Sayan Basu, MBBS, MS

9140-30612625 sayanbasu@lvpei.org

View on ClinicalTrials.gov More Corneal Injuries trials