Using cultured corneal cells to treat limbal stem cell deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of autologous cultured corneal epithelium (CECA) grafts for patients suffering from limbal stem cell deficiency. The approach involves surgically transplanting cultured corneal cells to reconstruct damaged tissue in the eye. The study aims to assess how well this treatment can restore corneal health and improve vision in affected individuals. It includes participants of all genders, with a planned inclusion of minors, and requires a small biopsy from a healthy part of the eye for the procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

All genders

* Adults
* Minors
* LSCD in one or two eyes. A minimum of 1-3 mm2 of undamaged limbus is required for a biopsy to be taken without foreseeable adverse consequences for the donor eye

Exclusion Criteria:

* Donor eye not sufficiently healthy to allow for the harvesting of a 1-3 mm2 limbal biopsy without foreseeable consequences for the donor eye
* Pregnancy
* Breast-feeding
* Incapacitated person
* known allergy to aprotinine (Trasylol (R))
* Hypersensibility to bovine proteins

Where it's running

• University Health Network - Toronto Western Hospital
  Toronto, Ontario, Canada Recruiting
• CIUSSS de l'Est de l'île de Montréal
  Montreal, Quebec, Canada Recruiting
• McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine
  Montreal, Quebec, Canada Recruiting
• Centre universitaire d'Ophtalmologie CHU de Québec - HSS
  Québec, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Ralph Kyrillos, MD FRCS (C) — CHU de Quebec

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Limbal Stem Cell Deficiency: Observational Look at How It Manages Over Time

  This study follows people with limbal stem cell deficiency to see how the condition progresses and how care is managed over time, without giving any experimental treatment.

  Recruiting at 8 sites Claris Biotherapeutics, Inc. · Carmel, Indiana and 7 other locations · NCT07636590

• Limbal function and tear protein changes in glaucoma

  This study tests whether glaucoma and long-term glaucoma medicines change limbal stem cell–related corneal epithelial thickness and tear proteins in people with glaucoma, ocular hypertension, or healthy adults.

  Recruiting National Taiwan University Hospital · Hsinchu · NCT07119580

• Evaluating a new eye treatment for Limbal Stem Cell Deficiency

  This study is testing a new eye drop treatment for people with Limbal Stem Cell Deficiency to see if it is safe and helps improve their condition.

  Recruiting at 6 sites Phase 1 Claris Biotherapeutics, Inc. · Loma Linda, California and 5 other locations · NCT06452316

• Using cultured oral mucosa to treat severe eye conditions

  This study is testing whether using skin cells from the inside of the mouth can help people with severe eye conditions regain their vision and improve their quality of life.

  Recruiting Phase 1/2 Hospices Civils de Lyon · Lyon · NCT03949881

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.