Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy(SMD)
This trial is active, not recruiting.
|Condition||stargardt's macular dystrophy|
|Sponsor||CHABiotech CO., Ltd|
|Start date||September 2012|
|End date||March 2015|
|Trial size||3 participants|
|Trial identifier||NCT01625559, CHA_CTP_0903|
The purpose of this study is:
- To evaluate the safety and tolerability of RPE cellular therapy in patients with SMD Group
- When-MA09-hRPE cell transplantation to evaluate the safety of surgical procedures.
- In future studies intended to assess the number of transplanted hRPE cells.
- In the past, MA09-hRPE cell therapy used in the study was to evaluate the validity of the potential.
- Homologous retinal pigment epithelial cells derived from embryonic stem cells, future studies of drugs that are used in representing the potential validity to evaluate the optimal dose.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Biological: MA09-hRPE Cellular therapy
safety and tolerance of transplantation
time frame: 18 months
Evidence of successful engraftment
time frame: 18 months
Male or female participants at least 20 years old.
Inclusion Criteria: - Adult male or female over 20 years of age. - 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 malignancy. - 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
|Official title||A Phase I, Open-Label, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial(MA09-hRPE) Cells in Patients With Stargardt's Macular Dystrophy(SMD)|
|Principal investigator||Wonkyung Song, MD. PhD.|
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