The trial will be conducted by French tissue bank, TBF Génie Tissulaire.
An upcoming clinical trial from TBF Génie Tissulaire (NCT05200000)1 aims to assess the impact of eye drops made of Wharton's jelly extract (SygeLIX-Coll-T) in the treatment of chronic keratitis that failed available therapies.
Wharton’s jelly extract is a primordial mucous connective tissue of the umbilical cord present between the amniotic epithelium and the umbilical vessels. In recent years, it has been found that this substance contains primitive mesenchymal stem cells (MSC) and yields the highest concentration of MSC per milliliter of other allogenic tissues.2
A recent study showed “Wharton’s jelly formulation demonstrated the presence of growth factors, cytokines, hyaluronic acid, and extracellular vesicles in clinically relevant quantities, in amounts greater compared with other biologics. And that “the presence of multiple factors within one formulation may help reduce inflammation, decrease pain and augment healing of musculoskeletal injuries.”3
The upcoming trial will be conducted by TBF Génie Tissulaire, a tissue bank in France that offers freeze-dried, sterile and practical Viro-inactivated amniotic membranes for ophthalmology. Six hospitals across France are currently recruiting 15 men or women between 18 and 80 with persistent corneal ulceration and who have shown resistance to medical treatment for more than one month or recurrence after medical treatment.1
It will take place over 40 days in which the patients put 1 drop of SygeLIX-Coll-T into the affected eye 5 times a day. SygeLIX-Coll-T is described as a “reconstituted suspension made of Trehalose and chemically treated, grinded, freeze-dried and sterilized Wharton's Jelly used by the patient as eye drops.”1
The primary outcome measure of the trial is the absence of aggravated inflammatory signs, worsening of visual acuity or other side effects. With secondary outcome measures of re-epithelialization of the cornea, improvement of dry eyes signs and symptoms, and improvement of visual acuity.
Results from the trial are expected at the end of 2023.