Autologous Platelet Lysate in Corneal Epithelial Defects

NCT ID: NCT02979912

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-16

Study Completion Date

2019-01-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Persistent Corneal Epithelial Defect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Platelet Lysate

Autologous platelet lysate dispensed into eye droppers to be applied four times a day for a total of four weeks.

Group Type EXPERIMENTAL

Platelet Lysate

Intervention Type BIOLOGICAL

Eye drops of Platelet Lysate

Interventions

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Platelet Lysate

Eye drops of Platelet Lysate

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanan Jafar

OTHER

Sponsor Role lead

Responsible Party

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Hanan Jafar

Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Abdallah Awidi, MD

Role: STUDY_DIRECTOR

Cell Therapy Center

Locations

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Cell Therapy Center

Amman, , Jordan

Site Status

Countries

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Jordan

References

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Abu-Ameerh MA, Jafar HD, Hasan MH, Al Bdour MD, Msallam M, Ababneh OH, Alhattab DM, Al-Kurdi B, Awidi AA, Awidi AS. Platelet lysate promotes re-epithelialization of persistent epithelial defects: a pilot study. Int Ophthalmol. 2019 Jul;39(7):1483-1490. doi: 10.1007/s10792-018-0968-1. Epub 2018 Jul 5.

Reference Type DERIVED
PMID: 29978342 (View on PubMed)

Other Identifiers

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PEDUJCTC

Identifier Type: -

Identifier Source: org_study_id

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