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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 belowSelect...
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.
Select...
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
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be an adult male or female over 18 years of age.The subject has the ability to consent to the study by providing a written signature on the consent form.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 availableStudy 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.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 normalThere is no history of cancer in other parts of the body, except for some cases of non-melanoma skin cancerThe person is fit enough to have surgery that may require general anesthesia, as well as to undergo a short course of systemic corticosteroid therapy.You have a history of vision problems in the eye being studied.You are physically healthy enough to have a surgery called vitrectomy and receive an injection under your retina.You have an eye condition or problem that would make it difficult to accurately evaluate your eye during the study.You have had a surgery called vitrectomy in the eye being studied.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.You currently have an eye infection or inflammation, or have had a previous history of eye inflammation that could make surgery risky for you.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.
Research Study Groups:
This trial has the following groups:- Group 1: human retinal progenitor cells (hRPC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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:
- Massachusetts Eye and Ear Infirmary: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
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