Autologous Platelet Lysate in Corneal Epithelial Defects

Phase 1

Completed

• Conditions: Persistent Corneal Epithelial Defect
• Interventions: Biological: Platelet Lysate

• Registration Number: NCT02979912
• Lead Sponsor: Hanan Jafar

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-02
• Study Start: 2017-02-16
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platelet Lysate	Platelet Lysate	Autologous platelet lysate dispensed into eye droppers to be applied four times a day for a total of four weeks.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops	2 months	Evaluation of the safety and tolerability of PL in the treatment of PED by monitoring any adverse event resulting from the eye drops.

Secondary Outcome Measures

Name	Time	Method
Assessment of the efficacy by clinical judgment	6 months	Efficacy of the given eye drops will be clinically evaluated by measuring the degree of healing of the epithelial defect

Trial Locations

Locations (1)

Cell Therapy Center; 🇯🇴 Amman, Jordan