Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cells Lenses | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of AEs from subjects receiving administration to Day 18 post-administration | during the treatment period and within 14 days after treament |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal fluorescein staining scores | Changes in corneal fluorescein staining scores | From baseline to Day 4 and Day 18 post-administration |
| Ocular surface disease | Changes in ocular surface disease index scores |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Jiexing | Contact | +86 183 0200 2029 | jxchen@procapzoom.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From baseline to Day 4 and Day 18 post-administration |
| Schirmer's test | Changes in Schirmer's test | From baseline to Day 4 and Day 18 post-administration |
| Tear osmolarity | Changes in tear osmolarity | From baseline to Day 4 and Day 18 post-administration |