Stem Cell Therapy for Outer Retinal Degenerations

Federal University of São Paulo15 enrolled

Overview

This study is a Phase I/II , open label,non randomized, prospective study to determine the safety of human embryonic stem cell derived Retinal pigmented epithelium (hESC RPE) sub retinal injections versus hESC RPE seeded on a polymeric substrate implanted in the sub retinal space,

To determine whether the surgical implantation of a human embryonic stem cell-derived retinal pigmented epithelium (hESC-RPE) monolayer seeded onto a polymeric versus hESC-RPE injections into the sub retinal space is a safe procedure. 6 Patients will receive hESC-RPE cell injections (100000 cells) in the sub retinal space (2 Dry Age-related macular degeneration (AMD), 2 Wet AMD with disciform scar and 2 with Stargardt's disease). Also 5 patients Dry AMD, 5 patients with Wet AMD with disciform scar and 5 patients with Stargardt's disease with receive a subretinal implantation of the hESC-RPE seeded in a monolayer in a polymeric substrate. Patients will be enrolled sequentially, and after the procedure the patients will be followed for 1 year.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

injection of hESC-RPE in suspensionPROCEDURE

The first six patients will receive a sub retinal injection of hESC-RPE in solution after a complete pars plana vitrectomy to access safety of the cell implant alone.

injection hESC-RPE seeded in a substratePROCEDURE

Fifteen patients will receive a sub-retinal implantation of embryonic stem cell derived retinal pigmented epithelium seeded in a polymeric substrate to access safety of substrate seeded with RPE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with AMD ( Dry , Wet after failure of treatment, disciform scars) * Patients with Stargardt's Disease BCVA on the selected eye: worse than 20/200 Exclusion Criteria: * Other ophthalmological diseases( Glaucoma, Diabetic Retinopathy, Previous retinal surgery, uveitis) * Systemic diseases with contraindication for surgical procedures with local anaesthesia

Locations (1)

Federal University of Sao Paulo

São Paulo, Brazil

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events of sub retinal implantation of stem cell derived retinal pigmented epithelium in the sub retinal space.

Incidence of surgical related side effects: Retinal detachment, Ocular inflammation, Increase in intraocular pressure, Infection( endophthalmitis), Loss of vision due to surgical, related complications

Time frame: 1 year

Secondary Outcomes

Incidence of side effects related to the treatment itself( injection and implantation of sub retinal stem cell related RPE)

Inflammation/rejection Cell migration/differentiation Tumor formation Proliferative vitreoretinopathy/Retinal detachment Implant migration

Time frame: 1 year

Data from ClinicalTrials.gov

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