Treatment of Age-related Macular Degeneration by Fetal Retinal Pigment Epithelial Cells Transplantation

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Criteria

Inclusion Criteria:

• Diagnosis of dry AMD or non-exudative AMD (geographical atrophy>250μm, involving central fovea of macular; or AMD with fibrous disciform scar and maintained stationary for at least 3 months)

• Experimental eye with best-corrected visual acuity (BCVA) of no more than 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.