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The effect of stem cell secretions isolated from the newborn's umbilical cord in the treatment of dry eye manifestations and tear secretion in patients with transplant versus host disease

Effect of human umbilical cord Whartons jelly-derived Mesenchymal stem cells exosomes in treatment of Dry Eye Related to Graft-Versus-Host Disease

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240508061704N3
Enrollment
10
Registered
2025-05-10
Start date
2024-12-05
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye in GVHD disease. Complications of bone marrow transplant

Interventions

Intervention 1: Intervention group: First, exosomes isolated from umbilical cord Wharton's jelly mesenchymal stem cells are isolated and stored in phosphate buffered saline (PBS) in a freezer. After a

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients between 30-60 years old who have dry eyes and have been clinically and serologically diagnosed with GVHD by an ophthalmologist and hematologist Patients in whom the previous use of artificial tears could not relieve the symptoms of dry eyes Patients who have symptoms of eye redness, dryness, burning sensation, foreign body sensation, eye surface discomfort or visual fatigue in at least one eye Patients whose tear secretion test in both eyes is = 10 mm / 5 minutes and tear break time is less than 10 seconds and the degree of corneal fluorescein staining is more than 4.

Exclusion criteria

Exclusion criteria: People who are allergic to any medicine Pregnant or lactating women Patients with active fungal, bacterial or viral keratitis or conjunctivitis People who have serious heart, lung, liver or kidney or systemic diseases Patients who have incurable eye diseases before the study; Such as glaucoma, uveitis People who use contact lenses and do not want to remove them in the study People who have had eye surgery (including cataract surgery) in the last three months People who have simultaneously enrolled in other interventional clinical studies People who have used eye drops that may affect the clinical study in the last 24 hours.

Design outcomes

Primary

MeasureTime frame
Tear secretion is measured using the Schirmer test, which measures the amount of wetting of filter paper. Timepoint: Measurements are taken before the start of treatment and after 12 weeks. Method of measurement: Filter paper is placed next to the eye and the amount of wetting by tears is reported in millimeters.

Secondary

MeasureTime frame
The amount of change in the height of the tear meniscus is measured. Timepoint: Measurements are taken before the start of treatment and after 12 weeks. Method of measurement: Imaging is performed with a slit lamp device.;The detection of foreign bodies in the eye is measured using fluorescein orange and blue light. Timepoint: Measurements are taken before the start of treatment and after 12 weeks. Method of measurement: Number.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegar Azarpira

Shiraz University of Medical Sciences

negarazarpira@gmail.com+98 71 3628 1407

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026