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The goal of this clinical trial is to assess efficacy and safety in patients with myopic chorioretinal atrophy.
The main question it aims to answer are:
• Percentage of changes in the chorioretinal atrophic area
Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy.
Researchers will compare non-therapeutic eye to see if the changes is significant different.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| therapeutic group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pars plana vitrectomy | Procedure | One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of changes in the chorioretinal atrophic area | Assesment by the principal investigator or sub-investigator will be conducted and central committee will adjudicate the assessment. | Just before transplantation,after 3days and 1,2,4,8,12,16,20,24,32,40,52weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hitoshi Kusano, M.D. | PhamaBio Coorporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya city university hospital | Nagoya | Aichi-ken | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39716323 | Derived | Nagano N, Hirano Y, Kimura M, Morita H, Yasukawa T. Preclinical study of novel human allogeneic adipose tissue-derived mesenchymal stem cell sheets toward a first-in-human clinical trial for myopic chorioretinal atrophy. Stem Cell Res Ther. 2024 Dec 23;15(1):498. doi: 10.1186/s13287-024-04118-z. |
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