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Cell Therapy

hRPC for Retinitis Pigmentosa(hRPCRP Trial)

Phase 1 & 2
Waitlist Available
Led By Jason Comander, MD
Research Sponsored by ReNeuron Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be able to complete the entire microperimetry test, and demonstrate adequate fixation and consistency between baseline readings such that the accuracy of both baseline and follow on testing should enable the detection of clinically significant changes in retinal sensitivity
Have clinical diagnosis of RP, based upon one or more of the following: clinical features, medical imaging, electrophysiological measures and genetic testing, if available. Genetic confirmation is not obligatory
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up24 months
Awards & highlights
No Placebo-Only Group

hRPCRP Trial 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

hRPCRP Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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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.
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You are physically healthy enough to have a surgery called vitrectomy and receive an injection under your retina.
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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
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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.
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The patient's serum chemistry and hematology are normal
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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.

hRPCRP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
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)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

hRPCRP Trial Design

1Treatment groups
Experimental Treatment
Group I: human retinal progenitor cells (hRPC)Experimental Treatment1 Intervention
Single subretinal administration of human retinal progenitor cells (hRPC)

Find a Location

Who is running the clinical trial?

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

Media Library

hRPC (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02464436 — Phase 1 & 2
Retinitis Pigmentosa Research Study Groups: human retinal progenitor cells (hRPC)
Retinitis Pigmentosa Clinical Trial 2023: hRPC Highlights & Side Effects. Trial Name: NCT02464436 — Phase 1 & 2
hRPC (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02464436 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts currently underway for this experiment?

"At this time, it does not appear that clinicaltrials.gov is hosting any recruitment for the study initially posted on December 1st 2015 and last edited on January 19th 2022. However, over 50 other medical trials are presently seeking participants to join their studies."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Florida
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Massachusetts Eye and Ear Infirmary
Oregon Health and Science University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

What questions have other patients asked about this trial?

What are possible side effects of this trial? How long do screenings take and how often would I have visit for testing/procedure updates?
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Massachusetts Eye and Ear Infirmary: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email
~3 spots leftby Dec 2024