NCT05658237

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

December 12, 2022

Last Update Submit

August 12, 2025

Conditions

Myopic Chorioretinal Atrophy

Keywords

regenerative productmesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

therapeutic group

EXPERIMENTAL
Procedure: Pars plana vitrectomy

Interventions

Pars plana vitrectomyPROCEDURE

One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.

therapeutic group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 20 years or older at the time of consent acquisition
  • Patients with binocular intensity myopia (myopia of -6.0 diopter (D) or more) or patients with axial length (26 mm) or more equivalent to -6.0 D
  • Corrected characters of the test eye patients with visual acuity of less than 60 characters (equivalent to decimal visual acuity 0.32)
  • Patients diagnosed with binocular myopic chorioretinal atrophy and having atrophy of 1 papillary diameter (1.5 mm) or more in the area within 2 papillary diameter (3.0 mm) including the fovea centralis in the subject eye
  • Patients without active choroidal neovascularization

You may not qualify if:

  • Patients with abnormal findings that pose a problem in clinical trial participation in screening tests.
  • Patients with positive hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV) antibody, Human immunodeficiency virus (HIV) antibody, Human T-lymphotropic virus type 1 (HTLV-1) antibody, syphilis serum reaction
  • Patients with allergies to human serum albumin antibiotics, trypsin
  • Patients with eye infections
  • Patients with other retinal diseases (diabetic retinopathy, hypertensive retinopathy, vascular occlusion)
  • Patients with confirmed optic nerve atrophy
  • Patients with glaucoma who cannot control intraocular pressure
  • Patients with findings associated with myopic traction macular disease (apparent posterior macular tumor, vitreous macular traction, retinal separation, macular hole detachment, macular hole)
  • Patients with atrophy in all areas of the circle within 3 papilla diameter (4.5 mm) (9.0 mm in diameter) from the fovea
  • Patients with corrected visual acuity of control eye 0.08 or less
  • Patients with severe blood disorders, heart failure, liver disorders, and renal disorders
  • Patients diagnosed with malignant tumor within 5 years or patients requiring treatment
  • Pregnant women, lactating women, patients wishing to become pregnant during the trial period
  • Patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial
  • Patients with drug addiction or alcoholism
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagoya city university hospital

Nagoya, Aichi-ken, Japan

Location

Related Publications (1)

  • 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.

    PMID: 39716323DERIVED

Study Officials

  • Hitoshi Kusano, M.D.

    PhamaBio Coorporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

December 20, 2022

Study Start

February 17, 2023

Primary Completion

January 31, 2026

Study Completion

March 31, 2026

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)