hRPC for Retinitis Pigmentosa

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Retinitis Pigmentosa+1 More
hRPC - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a cell therapy for retinitis pigmentosa, in which participants will receive a single injection of hRPC cells in one eye. The goal is to evaluate safety and tolerability, with some preliminary testing of efficacy.

Eligible Conditions
  • Retinitis Pigmentosa

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 24 months

24 months
Safety (Anatomical endpoint relating to retinal function in implant location - Color Fundus Photography)
Safety (Anatomical endpoint relating to retinal function in implant location - Fundus autofluorescence)
Safety (Anatomical endpoint relating to retinal function in implant location - Spectral domain-OCT)
Safety (Change in retinal sensitivity in the area overlying the implanted hRPC as compared with untreated retina)
Safety (Visual function measure: change in visual acuity)
Safety (Visual function measure: change in visual field: Goldmann visual field, microperimetry and FST)
6 months
Safety over the six months after treatment as assessed by the incidence of treatment emergent adverse events (TEAEs) and changes from baseline in other safety parameters.

Trial Safety

Trial Design

1 Treatment Group

human retinal progenitor cells (hRPC)
1 of 1
Experimental Treatment

29 Total Participants · 1 Treatment Group

Primary Treatment: hRPC · No Placebo Group · Phase 1 & 2

human retinal progenitor cells (hRPC)
Drug
Experimental Group · 1 Intervention: hRPC · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

ReNeuron LimitedLead Sponsor
7 Previous Clinical Trials
213 Total Patients Enrolled
Vince HolmesStudy DirectorReNeuron Limited
Jason Comander, MDPrincipal InvestigatorMassachusetts Eye and Ear Infirmary (MEEI)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The subject has the ability to consent to the study by providing a written signature on the consent form.
You must be an adult male or female over 18 years of age.
Study subjects must have a corrected ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity of 35 letters or less in the study eye for cohorts 1-5, a corrected ETDRS visual acuity of 63 letters (approximately 20/63) to 36letters (approximately 20/200) in the study eye for cohorts 6-8, and a corrected ETDRS visual acuity of 8 letters (approximately 20/800) to 68 letters (approximately 20/50) for cohorts 9 and on.
The test should be able to be completed without difficulty, and the patient's fixation and consistency between readings should be consistent enough to allow for the accurate detection of changes in retinal sensitivity.
You must be medically able to undergo a surgical procedure to remove the vitreous gel from your eye and an injection into the space below your retina.
The patient's serum chemistry and hematology are normal
There is no history of cancer in other parts of the body, except for some cases of non-melanoma skin cancer
This person has negative serology for human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), meaning that they have not been infected with any of these viruses.
The person is fit enough to have surgery that may require general anesthesia, as well as to undergo a short course of systemic corticosteroid therapy.
People who have RP have a clinical diagnosis based on one or more of the following: clinical features, medical imaging, electrophysiological measures and genetic testing, if available

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Florida50.0%
Texas25.0%
Idaho25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Massachusetts Eye and Ear Infirmary50.0%
Oregon Health and Science University50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Most responsive sites:
  1. Massachusetts Eye and Ear Infirmary: < 24 hours
Typically responds via
Email100.0%
Average response time
  • < 1 Day