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Amniotic epithelial stem cell eye drops for ocular cGVHD : a single arm, open clinical study

Amniotic epithelial stem cell eye drops for chronic graft versus host disease associated dry eye: a single arm, open clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057857
Enrollment
Unknown
Registered
2022-03-19
Start date
2022-06-20
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

ocular Graft Versus Host Disease

Interventions

G1:Amniotic epithelial stem cell eye drops
G2:Amniotic epithelial stem cell eye drops
G3:Amniotic epithelial stem cell eye drops
G4:Amniotic epithelial stem cell eye drops

Sponsors

The Hematology Department of the Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients = 18 years old who have received allogeneic hematopoietic stem cell transplantation (allo HSCT), regardless of gender; 2. At least one eye has one of the following symptoms: dryness, burning sensation, foreign body sensation, eye surface discomfort or decreased vision; 3. Tear secretion test of any eye (Schirmer test) = 10mm/5min; 4. Corneal fluorescein staining scores (FLCs)<6; 5. Tear film rupture time (TBUT)<10 seconds; 6. Obtain the informed consent of patients and their families, and sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. People who are allergic to any component of the study drug; 2. Have active fungus, bacteria, viral keratitis or conjunctivitis and other acute eye diseases; 3. People with other chronic eye diseases unrelated to chronic graft-versus-host disease: such as uveitis, retinitis pigmentosa, etc; 4. Those who wear contact lenses and are unwilling to remove them during the study; 5. Ophthalmic surgery (including cataract surgery) has been performed in recent three months; 6. Pregnant or lactating women; 7. Unable to complete the study as required by the researcher; 8. Any other situation that the researcher thinks is not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index (OSDI);

Secondary

MeasureTime frame
Schirmer test;Tear film break-up time (TBUT);Best-corrected visual acuity (BCVA);the score of conjunctival redness;Tear meniscus height (TMH);In?vivo?confocal?microscopic? (IVCM);Photographic examination of the anterior segment;Optical Coherence Tomography (OCT) imaging test;Corneal fluorescein staining;

Countries

China

Contacts

Public ContactXi Zhang

Xinqiao hospital of the army medical university

zhangxxi@sina.com+86 13808310064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026