Clinical Study of Transplanting Human Retinal Pigment Epithelial Cells for Treatment of Macular Degeneration

Macular Degeneration Clinical Trial

Official title:

Clinical Study of Transplanting Human Retinal Pigment Epithelial Cells for Treatment of Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03215576
• Other study ID #: DFSC-2016(CR)-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 10, 2017
• Last updated: July 10, 2017
• Start date: February 8, 2017
• Est. completion date: August 8, 2020

Study information

• Verified date: February 2017
• Source: Shanghai East Hospital
• Contact: panfeng fang, Ph.D
• Phone: 08613912364746
• Email: pfeng.fang[@]eye-cure.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label investigation of the safety and preliminary efficacy of the subretinal transplantation of human retinal pigment epithelial cells on Macular Degeneration.

Description:

This study is an open-label investigation of the safety and preliminary efficacy of the sub retinal transplantation of human retinal pigment epithelial cells on Macular Degeneration. Nine patients are recruited through specific inclusive/exclusive criteria after signed an informed consent. Experimental and self-controlled eye will be determined based on best-corrected visual acuity (BCVA). The eye with BCVA of 20/200 or worse will be determined as experimental eye, which will undergo one sub retinal injection. Three dose cohorts (100 000, 300 000, and 500 000 cells) were treated for each eye disorder, while the other eye (BCVA 20/200 or better) as control and will not receive the surgery.

HuRPE cells are conformed with Good manufacturing practices (GMP). Certified HuRPE cells will be administered into the subretinal space of experimental eye through a standard surgical approach. Subjects will be monitored with ophthalmologic and systemic examinations frequently at regular post-transplant intervals after HuRPE cells transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: August 8, 2020
• Est. primary completion date: August 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 50~80 years;

• Diagnosed as atrophic macular degeneration (>250 microns of geographic atrophy involving central fovea);

• BCVA of study eye equal to or worse than 20/200, BCVA of control eye equal to or better than 20/200;

• Good health condition: Normal vital signs, electrocardiogram, routine blood and urine tests;

• Understand and be able to sign the informed consent.

Exclusion Criteria:

• Hemoglobin<10g/dL; platelet count<100k/mm^3;neutrophil count<1000/mm^3;

• ALT/AST>1.5; creatinine level>1.3mg/dL;

• Presence of glaucomatous optic neuropathy in the study eye;

• Progressive Cataract causing difficulty of retina examination;

• Any eye surgery other than cataract surgery within previous 3 months;

• History of retina detachment repair in the study eye;

• Uveitis or other intraocular inflammatory disease in the study eye;

• Any other sight-threatening ocular disease;

• Participation in any clinical trial of a drug by ocular or systemic administration within the past 6 months;

• History of malignancy (except excised basal cell or squamous cell of skin);

• History of myocardial infarction;

• History of diabetes mellitus;

• History of Parkinson's disease or Alzheimer's disease;

• Any current immunosuppressive therapy other than intermittent or low dose corticosteroids;

• Any other medical condition that affects patient compliance, patient safety, or the outcome of this clinical study.

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• HuRPE
HuRPE cells were transplanted directly into the subretinal space of experimental eye in a single procedure

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai East Hospital	Eyecure Therapeutics Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and Severity of Treatment-Related Adverse Events of sub retinal implantation of retinal pigmented epithelium. Incidence of surgical related side effects.	Comparison of surgical related side effects and HuRPE implantation related Adverse Events.	Two years following HuRPE transplantation
Secondary	Best corrected visual acuity	ETDRS is designed to accurately measure visual acuity via ETDRS Scoring.	Two years following HuRPE transplantation
Secondary	OCT	Optical coherent tomography	Two years following HuRPE transplantation
Secondary	mERG	multifocal ERG	Two years following HuRPE transplantation
Secondary	fundus photography		Two years following HuRPE transplantation