Suspension made with amniotic membrane: clinical trial

Area of Science:

• Ophthalmology
• Regenerative Medicine
• Tissue Engineering

Background:

• Ocular surface diseases pose significant challenges to vision and eye health.
• Conventional therapies often yield limited success for severe or persistent corneal conditions.
• Amniotic membrane transplantation is a recognized treatment, but invasive procedures carry risks.

Purpose of the Study:

• To evaluate the efficacy and safety of a novel amniotic membrane suspension for treating various ocular surface diseases.
• To determine if this less invasive preparation can promote corneal healing and reduce inflammation.

Main Methods:

• A suspension of homogenized amniotic membrane was prepared and administered to 21 patients with diverse ocular surface conditions.
• Patients had failed to respond to at least four months of conventional therapy.
• Evaluations included fluorescein staining, assessment of epithelial defects, inflammation, symptoms, and impression cytology.

Main Results:

• All patients showed complete epithelial healing and negative fluorescein staining within 15-30 days.
• Significant reduction in conjunctival inflammation and improvement in patient-reported symptoms were observed.
• Impression cytology revealed a significant corneal recovery, including a decrease in CK19+ cells, with stable results throughout the 5-month follow-up.

Conclusions:

• The amniotic membrane suspension is a safe and effective treatment for ocular surface diseases.
• This therapy is less traumatic than amniotic membrane implants and can be repeated.
• It offers a promising therapeutic option for patients with corneal superficial defects.