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A Study of Stem Cells Lenses in the coGVHD Subjects | Clinical Trials | Clareo Health

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A Study of Stem Cells Lenses in the coGVHD Subjects

A Single Dose Phase I Study to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Stem Cells Lenses in the Chronic Ocular Graft-versus-Host Disease Subjects

NCT06952114•Guangdong ProCapZoom Biosciences Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a single dose, Phase I study to evaluate the safety, tolerability, and preliminary effectiveness of Stem cells Lenses in the coGVHD Subjects. Three subject's enrollments are Expected. Each subject will wear Stem cells Lenses loaded for four consecutive days. After a 4-day treatment period, a 14-day follow-up observation period will be conducted to monitor for potential adverse events. This study aims to treat patients with chronic ocular graft-versus-host-disease. Currently, there are no approved drugs for the treatment of coGVHD. Three conventional treatments currently available-systemic administrations, topical treatments, and surgical therapies-have various limitations. allo-HSCT involves the transplantation of hematopoietic stem cells from a healthy donor to a recipient with malignant blood diseases such as leukemia to regenerate the hematopoietic and immune systems. A logical strategy for treating the condition directly would involve the administration of UCMSCs. Using UCMSCs to locally modulate donor T cells and prevent them from attacking the ocular surface tissues of the recipient would be a viable approach to the etiological treatment of coGVHD.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18-65 years old, including the boundary value, no gender restriction.
•2. Subjects diagnosed with coGVHD caused by hematopoietic stem cell transplantation, with at least 3 months post-transplantation.
•3. Meet the clinical diagnostic criteria for coGVHD in the eye: presence of at least one of the following symptoms in either eye: 1) Dryness, burning sensation, foreign body sensation, ocular discomfort, or decreased vision. 2) The total score in either eye ≥ 8 in the absence of systemic chronic graft-versus-host-disease (cGVHD) symptoms, or ≥ 6 in the presence of systemic cGVHD symptoms. (Total score = Schirmer's test score + CFS score + OSDI score + conjunctival congestion).
•4. Eye-related symptoms treated conventionally for 1 week prior to screening with no improvement or inadequate response (severity not reduced based on the grading scale of coGVHD).
•5. Karnofsky Performance Status (KPS) score \> 60.
•6. Adequate function of important organs: Absolute neutrophil count ≥ 1.0×10\^9/L, platelets count ≥ 75×10\^9/L, hemoglobin ≥ 10g/dL, bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the ULN, and serum creatinine ≤ 1.5 times the ULN.
•7. Subjects and their partners have no fertility plans from screening to 6 months after the end of the trial and agree to effective non-pharmacological non-drug contraceptive measures during the trial.
•8. Willing to participate in the study, understand and sign the ICF.

Exclusion Criteria

•1. Known allergy to any component of the investigational product.
•2. Subjects with any unstable or uncontrolled cardiovascular, pulmonary, gastrointestinal, urogenital, coagulation, immunological, endocrine, metabolic, or other medical conditions that the investigator believes will interfere with the study results or endanger the safety of the subjects.
•3. Subjects with other ocular diseases at screening:
•1. Other ocular diseases unrelated to coGVHD, such as blepharospasm.
•2. Acute active fungal, bacterial, or viral keratitis or conjunctivitis, or other acute eye infections.
•3. Corneal ulceration.
•4. Glaucoma, cataracts, or other ocular diseases assessed by the investigator to potentially affect efficacy and safety evaluation.
•4. Subjects with a history of Stevens-Johnson Syndrome.
•5. Subjects with a history of corneal refractive surgery (e.g., LASIK, PRK) or other corneal surgeries.
•6. Subjects who have undergone eye surgery within the previous 3 months.
+9 more criteria

Key Dates

Start Date

May 20, 2025

Primary Completion Date

December 30, 2025

Completion Date

February 28, 2026

Last Updated

May 8, 2025

Enrollment

ESTIMATED participants

Conditions

Chronic Ocular Graft-versus-host Disease

Interventions

Stem Cells Lenses

DRUG

Contacts

Chen Jiexing

CONTACT

+86 183 0200 2029 jxchen@procapzoom.com

Electrostimulation Study for Ocular Graft vs. Host Disease

NCT07166848

Chronic Ocular Graft-versus-host Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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