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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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Summary
This trial tests a new cell therapy where special cells are injected into the eye to help people with retinitis pigmentosa, a disease that causes vision loss. The goal is to see if these cells can repair or replace damaged parts of the eye.
Eligible Conditions
- Retinitis Pigmentosa
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: human retinal progenitor cells (hRPC)Experimental Treatment1 Intervention
Single subretinal administration of human retinal progenitor cells (hRPC)
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Who is running the clinical trial?
ReNeuron LimitedLead Sponsor
7 Previous Clinical Trials
212 Total Patients Enrolled
Jason Comander, MDPrincipal InvestigatorMassachusetts Eye and Ear Infirmary (MEEI)
Vince HolmesStudy DirectorReNeuron Limited
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 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 cancerYou have a history of vision problems in the eye being studied.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.
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