Trial | NCT03566147  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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
Study Started
Aug 01
2018
Anticipated
Primary Completion
Dec 31
2019
Anticipated
Study Completion
Mar 31
2020
Anticipated
Last Update
Aug 09
2018

Biological Human primary Retinal Pigment Epithelial (HuRPE) cells

HuRPE 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.

low dose group Experimental

300,000 HuRPE cells

middle dose group Experimental

500,000 HuRPE cells

high dose group Experimental

1,000,000 HuRPE cells

Criteria 

Inclusion Criteria:

Diagnosis of RP or LCA;
Experimental eye with best-corrected visual acuity (BCVA) of no more than 35 letters or visual field of less than 10 degree;
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
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.
No Results Posted