Treatment of RP and LCA by Primary RPE Transplantation

Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis by Primary Retinal Pigment Epithelial Cells Transplantation

Early Phase I Study of the Safety and Preliminary Efficacy of Human primary Retinal Pigment Epithelial (HuRPE) Cells Subretinal Transplantation in Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA) Patients

Inclusion Criteria:

1. Diagnosis of RP or LCA;
2. Experimental eye with best-corrected visual acuity (BCVA) of no more than 35 letters or visual field of less than 10 degree;
3. Patient understand and sign the consent form.

Exclusion Criteria:

1. Blood routine examination is abnormal (hemoglobin<10gm/dL; blood platelet count<100k/mm³; neutrophil count<1000/mm³)
2. Blood biochemistry is abnormal (ALT／AST>1.5; creatinine>1.3mg/dL)
3. Experimental eye has optic nerve atrophy caused by glaucoma
4. Experimental eye has retinal detachment, or has received retinal detachment surgery.
5. Patients with uveitis and other endophthalmitis
6. Patients with other ocular disease affecting vision.
7. Patients have participated in clinical study of ocular or systemic drug use in recent 6 months.
8. Patients with medical history of malignant cancer (except resected basal cell carcinoma and squamous-cell carcinoma).
9. Patients with medical history of myocardial infarction
10. Patient with diabetes
11. Patient with Parkinson disease or Alzheimer's disease
12. Patients are under the treatment of immunosuppressive agent (except intermittent, low-dose corticosteroid treatment).
13. Patients with other medical conditions that restricts the compliance and safety of patients, or affects experimental results.