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Investigating the safety and efficacy of Wharton's jelly mesenchymal stem cell exosomes on corneal epithelium defects

Investigating the effect of exosomes with regenerative and anti-inflammatory potential derived from Wharton jelly mesenchymal stem cells on the treatment of corneal epithelial defects

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240706062337N1
Enrollment
20
Registered
2024-10-10
Start date
2024-12-17
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Corneal epithelium defects. Disorder of cornea, unspecified

Interventions

Intervention group : Description: Patients will receive exosomes derived from Wharton jelly mesenchymal stem cells (WJ-MSCs) with regenerative and anti-inflammatory potential. Exosomes are prepared in

Sponsors

Vice Chancellor for Research, Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Participants aged 18-65 years. Individuals diagnosed with corneal epithelial defects, confirmed by clinical examination and imaging techniques. Patients with moderate to severe corneal epithelial defects that have not responded to conventional treatments. Participants should be generally healthy, without systemic diseases that could affect the study outcomes. Written informed consent obtained from all participants. Patients who have not received any other experimental treatments for corneal epithelial defects in the past 6 months. No active ocular infections or other significant ocular diseases (e.g., glaucoma, uveitis) that could interfere with the study. Willingness and ability to comply with study procedures and follow-up visits.

Exclusion criteria

Exclusion criteria: Patients with uncontrolled systemic diseases such as diabetes, autoimmune disorders, or severe cardiovascular conditions. Presence of other significant ocular diseases (e.g., glaucoma, uveitis) or active ocular infections that could interfere with the study outcomes. Patients who have received other experimental treatments for corneal epithelial defects within the past 6 months. Known allergies to any components of the exosome preparation or related substances. Pregnant or breastfeeding women. Patients currently undergoing immunosuppressive therapy or with a history of organ transplantation. Inability or unwillingness to comply with study procedures and follow-up visits. Any other medical condition that, in the opinion of the investigator, could compromise the safety of the patient or the integrity of the study data.

Design outcomes

Primary

MeasureTime frame
Improvement of epithelial defects. Timepoint: It is measured in weeks 1, 2 and 4. Method of measurement: Clinical examinations.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahmoud Nejabat

Shiraz University of Medical Sciences

psorc@yahoo.com+98 71 3233 0073

Outcome results

None listed

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