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hRPC for Retinitis Pigmentosa(hRPCRP Trial)
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.
- Retinitis Pigmentosa
hRPCRP Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
hRPCRP Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
hRPCRP Trial Design
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Who is running the clinical trial?
- 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.
- Group 1: human retinal progenitor cells (hRPC)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Most responsive sites:
- Massachusetts Eye and Ear Infirmary: < 24 hours
Average response time
- < 1 Day
Typically responds via
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