Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy(SMD)
NCT ID: NCT01625559
Last Updated: 2024-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
3 participants
INTERVENTIONAL
2012-09-30
2015-04-30
Brief Summary
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Detailed Description
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* to evaluate the preliminary efficacy of MA09-hPRE in patients with SMD
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MA09-hRPE administration
Biological: MA09-hRPE Cellular therapy
MA09-hRPE
MA09-hRPE cells
Interventions
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MA09-hRPE
MA09-hRPE cells
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of advanced SMD.
* The visual acuity of the eye to receive the transplant will be no better than hand movement.
* The visual acuity of the eye that is not to receive the transplant will be no better than 24 (20/320) Early Treatment of Diabetic Retinopathy Study (ETDRS) letters.
Exclusion Criteria
* History of myocardial infarction in previous 12 months.
* History of diabetes mellitus.
* Any immunodeficiency.
* Any current immunosuppressive therapy other than intermittent or low dose cortico steroids.
* Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
* Current participation in any other clinical trial.
* Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
* Any other sight-threatening ocular disease.
* Any chronic ocular medications. Any history of retinal vascular disease (compromised blood-retinal barrier). Glaucoma. Uveitis or other intraocular inflammatory disease. Significant lens opacities or other media opacity. Ocular lens removal within previous 3 months
20 Years
ALL
No
Sponsors
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CHABiotech CO., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Wonkyung Song
Role: PRINCIPAL_INVESTIGATOR
CHA Bundang Medical Center
Locations
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CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Countries
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References
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Sung Y, Lee MJ, Choi J, Jung SY, Chong SY, Sung JH, Shim SH, Song WK. Long-term safety and tolerability of subretinal transplantation of embryonic stem cell-derived retinal pigment epithelium in Asian Stargardt disease patients. Br J Ophthalmol. 2021 Jun;105(6):829-837. doi: 10.1136/bjophthalmol-2020-316225. Epub 2020 Jul 29.
Other Identifiers
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CHA_CTP_0903
Identifier Type: -
Identifier Source: org_study_id
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