Chronic Ocular Graft-versus-host DiseaseEarly Phase 1NCT06952114
A Study of Stem Cells Lenses in the coGVHD Subjects
A Early Phase 1 study testing Stem Cells Lenses in people with Chronic Ocular Graft-versus-host Disease, run by Guangdong ProCapZoom Biosciences Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Ocular Graft-versus-host Disease
- What is being tested?
- Stem Cells Lenses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 28 Feb 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years old, including the boundary value, no gender restriction.
- Subjects diagnosed with coGVHD caused by hematopoietic stem cell transplantation, with at least 3 months post-transplantation.
- 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).
- 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).
- Karnofsky Performance Status (KPS) score > 60.
- 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.
- 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.
- Willing to participate in the study, understand and sign the ICF.
Who cannot join
- Known allergy to any component of the investigational product.
- 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.
- Subjects with other ocular diseases at screening:
- Other ocular diseases unrelated to coGVHD, such as blepharospasm.
- Acute active fungal, bacterial, or viral keratitis or conjunctivitis, or other acute eye infections.
- Corneal ulceration.
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- Glaucoma, cataracts, or other ocular diseases assessed by the investigator to potentially affect efficacy and safety evaluation.
- Subjects with a history of Stevens-Johnson Syndrome.
- Subjects with a history of corneal refractive surgery (e.g., LASIK, PRK) or other corneal surgeries.
- Subjects who have undergone eye surgery within the previous 3 months.
- Subjects with a history of corneal contact lens wear who cannot remove them during treatment.
- Inability to understand and complete the OSDI questionnaire.
- Participation in other clinical trials within 3 months prior to screening.
- Subjects with systemic diseases or psychiatric histories that the investigator believes may increase the risk to subjects or affect the evaluation of the study results.
- Positive test results for human immunodeficiency virus antibodies, Treponema pallidum-specific antibodies (syphilis), or positive hepatitis C antibodies, surface antigen of hepatitis B, history of hepatitis B, or positive hepatitis B core antibody, with recent HBV-DNA levels ≥2000IU/mL in the past 3 months.
- Subjects with a history of solid tumors.
- Pregnant or lactating women.
- Subjects deemed unsuitable for participation in this trial by the investigator.
- Subjects with active infections will not be recruited.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Chronic Ocular Graft-versus-host Disease
- Being tested
- Stem Cells Lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cells LensesDrug
Each subject will wear Stem Cells Lenses 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.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cells Lenses group | Experimental | Each subject will wear Stem Cells Lenses 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. Receives: Drug: Stem Cells Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence and severity of AEs from subjects receiving administration to Day 18 post-administration
Measured: during the treatment period and within 14 days after treament
Secondary outcomes (4)
Corneal fluorescein staining scores
Changes in corneal fluorescein staining scores
Measured: From baseline to Day 4 and Day 18 post-administration
Ocular surface disease
Changes in ocular surface disease index scores
Measured: From baseline to Day 4 and Day 18 post-administration
Schirmer's test
Changes in Schirmer's test
Measured: From baseline to Day 4 and Day 18 post-administration
Tear osmolarity
Changes in tear osmolarity
Measured: From baseline to Day 4 and Day 18 post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start20 May 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ocular Graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong ProCapZoom Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952114
- Sponsor's protocol ID
- PLKR-SZ018-0-01
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06952114
- Acronym / sponsor ID
- PLKR-SZ018-0-01
- Conditions
- Chronic Ocular Graft-versus-host Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Guangdong ProCapZoom Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cells Lenses group | Experimental | Drug: Stem Cells LensesEach subject will wear Stem Cells Lenses 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-65 years old, including the boundary value, no gender restriction.
- Subjects diagnosed with coGVHD caused by hematopoietic stem cell transplantation, with at least 3 months post-transplantation.
- 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).
- 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).
- Karnofsky Performance Status (KPS) score > 60.
Key exclusion criteria (19 listed)
- Known allergy to any component of the investigational product.
- 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.
- Subjects with other ocular diseases at screening:
- Subjects with a history of Stevens-Johnson Syndrome.
- Subjects with a history of corneal refractive surgery (e.g., LASIK, PRK) or other corneal surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem Cells LensesEach subject will wear Stem Cells Lenses 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. | Drug | Stem Cells Lenses group |
Primary outcome
Adverse events
Time frame: during the treatment period and within 14 days after treament
Incidence and severity of AEs from subjects receiving administration to Day 18 post-administration
4 secondary outcomes
Corneal fluorescein staining scores
Time frame: From baseline to Day 4 and Day 18 post-administration
Ocular surface disease
Time frame: From baseline to Day 4 and Day 18 post-administration
Schirmer's test
Time frame: From baseline to Day 4 and Day 18 post-administration
Tear osmolarity
Time frame: From baseline to Day 4 and Day 18 post-administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Stem Cells Lenses in people with Chronic Ocular Graft-versus-host Disease, run by Guangdong ProCapZoom Biosciences Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Jiexing (+86 183 0200 2029, jxchen@procapzoom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: during the treatment period and within 14 days after treament). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.