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New treatment option for Total Bilateral Limbal Cell Deficiency
Official title Cultured Autologous Oral Mucosa Epithelial Sheet for the Treatment of Bilateral Limbal Stem Cell Deficiency
ClinicalTrials.gov ID: NCT03949881
What this study is testing
What is FEMJA transplatation?
FEMJA transplatation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for total bilateral limbal cell deficiency.
Also referred to as Cultivated oral mucosal epithelium transplantation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Some severe ocular burns or other rare ocular pathologies can be associated with a total loss of corneal epithelial stem cells (i.e. Limbal Stem Cell Deficiency - LSCD), which leads to cornea invasion by the conjunctiva and a subsequent opacification.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female aged ≥ 18 years
- Signed and dated informed consent for participation in the study
- Total bilateral limbal stem-cell deficiency
- Caused by thermal or chemical burn, cornea transplantation, and other bilateral disorders of the ocular surface
- Severe loss of vision (\<2/10 on decimal scale or/and EDTRS)
You likely can't join if
- Eye inflammation
- Strictly unilateral ocular affliction
- Acute systemic infection, objectified during consultation by the investigator and on the following paraclinical parameter: C Reactive Protein rate
- History of acute phase of ocular inflammation in the previous year
- History of neoplasic disease
- Glaucoma defined as intra ocular pressure (air tonometer and applanation tonometer) ≥ 22mmHg
See the full eligibility criteria
- Male or female aged ≥ 18 years
- Signed and dated informed consent for participation in the study
- Total bilateral limbal stem-cell deficiency
- Caused by thermal or chemical burn, cornea transplantation, and other bilateral disorders of the ocular surface
- Severe loss of vision (\<2/10 on decimal scale or/and EDTRS)
- The subject must be covered by a social security system
- Eye inflammation
- Strictly unilateral ocular affliction
- Acute systemic infection, objectified during consultation by the investigator and on the following paraclinical parameter: C Reactive Protein rate
- History of acute phase of ocular inflammation in the previous year
- History of neoplasic disease
- Glaucoma defined as intra ocular pressure (air tonometer and applanation tonometer) ≥ 22mmHg
- Total symblepharon (comprising eyelid aperture): impossibility to open the 2 eyes
- History of hyper sensibility or allergy to antibiotics or serum
- Women who are or may be pregnant or breastfeading
- Patients with any active infectious disease (HBV, HCV, HIV, HTLV-1 and syphilis)
- Patients who are otherwise ineligible for participation in the study in the opinion of the investigator.
- Delay of less than one year after chemical or thermal burns
- Person under judicial protection
- Contraindication related to anesthesia
- Contraindication to fluoresceine
- Oral mucosa tumor, pharynx or larynx tumor
- Fungal or viral infection of the ENT area
- Bacteria infection of the oral mucosa, pharynx or larynx.
- Hypersensitivity to ofloxacin (or other quinolone drugs), fluorometholone or betamethasone.
- Hypersensitivity to one of the excipients of the eye drops used: Monosodium phosphate, anhydrous disodium phosphate, polysorbate 80, sodium chloride, sodium edetate, polyvinyl alcohol, benzalkonium chloride...
- Phenylketonuria
- Psychotic states not yet controlled by treatment;
- Vaccination with a live vaccine
- Bacterial, fungal, myco-bacterial infection of eye structures.
- Some evolving viral infections (including hepatitis, herpes, chickenpox, shingles) or other viral infections of the cornea or conjunctiva (except for a keratitis to Herpes zoster).
- Patients treated with Class IA or III antiarrhythmics, tricyclic antidepressants, macrolides and antipsychotics
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.