MedTrace Logo

Safety and Tolerability of hRPC in Retinitis Pigmentosa

NCT02464436 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-07-06

No results posted yet for this study

Summary

hRPC is a cell therapy for retinitis pigmentosa. This is a first-in-human, dose escalation study in which participants with retinitis pigmentosa will receive a single subretinal injection of hRPC cells in one eye to evaluate safety and tolerability.

Participants will be followed for two years to evaluate the safety and tolerability of hRPC Additional testing will seek to establish any preliminary efficacy from hRPC.

Conditions

Interventions

DRUG

hRPC

Participants will undergo vitrectomy surgery and subretinal implantation of hRPC in the study eye.

Sponsors & Collaborators

  • ReNeuron Limited

    lead INDUSTRY

Principal Investigators

  • Jason Comander, MD · Massachusetts Eye and Ear Infirmary (MEEI)

  • Vince Holmes · ReNeuron Limited

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2022-06-30
Completion
2023-12-31

Countries

  • United States
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464436 on ClinicalTrials.gov