Overview

This trial is active, not recruiting.

Conditions age related macular degeneration, macular degeneration, amd
Treatment frpe cells
Phase phase 1/phase 2
Sponsor The First Affiliated Hospital with Nanjing Medical University
Start date February 2016
End date August 2018
Trial size 6 participants
Trial identifier NCT02868424, JSPH-fRPE-001

Summary

Phase I/II Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD) Patients

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subretinal transplantation of fRPE cells in experimental eye
frpe cells human fetal retinal pigment epithelial cells
fRPE cells transplantation directly into the subretinal space of one eye (experimental eye) in a single transplant procedure

Primary Outcomes

Measure
Number of subjects with adverse events
time frame: Two years following transplantation

Secondary Outcomes

Measure
Assessment of standardized ETDRS acuity testing
time frame: Two years following transplantation
Assessment of visual function changes
time frame: Two years following transplantation
Assessment of systemic condition
time frame: Two years following transplantation

Eligibility Criteria

Male or female participants from 50 years up to 90 years old.

Inclusion Criteria: - Diagnosis of dry AMD (geographical atrophy>250μm, involving central fovea of macular) - Experimental eye with best-corrected visual acuity (BCVA) of 20/400 and control eye with BCVA of more than or equal to 20/400 - Patients are in good state - Patient understand and sign the consent form. Exclusion Criteria: - Blood routine examination is abnormal (hemoglobin<10gm/dL; blood platelet count<100k/mm³; neutrophil count<1000/mm³) - Blood biochemistry is abnormal (ALT/AST>1.5; creatinine>1.3mg/dL) - Experimental eye has optic nerve atrophy caused by glaucoma - Patients need cataract surgery within a year - Patients have received cataract surgery and other ocular surgery in recent 3 months - Experimental eye has retinal detachment, or has received retinal detachment surgery. - Patients with uveitis and other endophthalmitis - Patients with other ocular disease affecting vision. - Patients have participated in clinical study of ocular or systemic drug use in recent 6 months. - Patients with medical history of malignant cancer (except resected basal cell carcinoma and squamous-cell carcinoma). - Patients with medical history of myocardial infarction - Patient with diabetes - Patient with Parkinson disease or Alzheimer's disease - Patients are under the treatment of immunosuppressive agent (except intermittent, low-dose corticosteroid treatment). - Patients with other medical conditions that restricts the compliance and safety of patients, or affects experimental results.

Additional Information

Official title Phase I/II Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD) Patients
Principal investigator Qinghuai Liu, M.D.
Description This study is a perspective, single-arm and open-labeled investigation of the safety and preliminary efficacy of unilateral subretinal transplantation of fRPE cells in subjects with dry Age-Related Macular Degeneration (AMD). The investigators will recruit and enroll 6 patients based on specific inclusive/exclusive criteria. Experimental and self-controlled eye will be determined based on best-corrected visual acuity (BCVA). The eye with BCVA of less than 20/400 will be determined as experimental eye, which will undergo subretinal injection of 100,000 fRPE cells, while the other one (BCVA of more than or equal to 20/400) as control eye, will not receive the surgery. fRPE cells will be obtained from the fetuses aborted in the Department of Obstetrics and Gynecology in Jiangsu Province Hospital from 2015 to 2018. The obtained fRPE cells will meet specific inclusive/exclusive criteria and conform to Good manufacturing practices (GMP). fRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be administered into the subretinal space of experimental eye through a standard surgical approach. Immunosuppressive agents will be administered orally to all subjects after transplantation. Dosage and time duration of immunosuppressive agents will be regulated strictly relying on the condition of immune rejection. Subjects will be monitored with ophthalmologic and systemic examinations frequently at regular post-transplant intervals after fRPE cell transplantation.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by The First Affiliated Hospital with Nanjing Medical University.