Autologous Platelet Lysate in Corneal Epithelial Defects

Persistent Corneal Epithelial Defect Clinical Trial

Official title:

The Use of Autologous Platelet Lysate in Persistent Corneal Epithelial Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979912
• Other study ID #: PEDUJCTC
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 16, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: March 2021
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate.

Description:

Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be taken in multiple doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 30, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 78 Years

Eligibility

Inclusion Criteria:

1. Cognitive ability to understand and sign the consent form.

2. Corneal ulcers that did not re-epithelialise after 1 week of conventional treatment (therapeutic contact lenses, topical artificial tears, eye packs and antibiotic eye-drops).

3. Clinical indications: corneal ulcer due to caustic substances, corneal epitheliopathy, corneal lesions following cataract surgery, recurrent ulcerative keratitis, corneal lesions due to a foreign body.

4. Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion Criteria:

1. Corneal ulcers which developed tissue scars.

2. Pregnant or lactating women.

Related Conditions & MeSH terms

• Persistent Corneal Epithelial Defect

Intervention

Biological:
• Platelet Lysate
Eye drops of Platelet Lysate

Locations

Country	Name	City	State
Jordan	Cell Therapy Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Hanan Jafar

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops	Evaluation of the safety and tolerability of PL in the treatment of PED by monitoring any adverse event resulting from the eye drops.	2 months
Secondary	Assessment of the efficacy by clinical judgment	Efficacy of the given eye drops will be clinically evaluated by measuring the degree of healing of the epithelial defect	6 months