Overview

This trial is active, not recruiting.

Condition stargardt's macular dystrophy
Treatment ma09-hrpe
Phase phase 1
Sponsor CHABiotech CO., Ltd
Start date September 2012
End date March 2015
Trial size 3 participants
Trial identifier NCT01625559, CHA_CTP_0903

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Biological: MA09-hRPE Cellular therapy
ma09-hrpe
MA09-hRPE: 50,000 cells

Primary Outcomes

Measure
safety and tolerance of transplantation
time frame: 18 months

Secondary Outcomes

Measure
Evidence of successful engraftment
time frame: 18 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by CHABiotech CO., Ltd.