jCell for Retinitis Pigmentosa
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called jCell for individuals with retinitis pigmentosa (RP), a condition that impairs vision, particularly in low light. Researchers aim to determine if a single injection of jCell can safely enhance vision over six months. Participants will receive either the jCell treatment or a sham (fake) injection for comparison. Suitable candidates have been diagnosed with RP and experience symptoms such as loss of peripheral vision or difficulty seeing in dim light. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you are using certain prohibited therapies or if you have used specific medications like hydroxychloroquine, chloroquine, or interferon with noted retinal abnormalities. If you were part of a N-acetyl cysteine (NAC) study, a 7-day washout period is required.
Is there any evidence suggesting that jCell (Famzeretcel) is likely to be safe for humans?
Research has shown that jCell (famzeretcel) is safe and well-tolerated. Studies found that a single injection of these eye cells did not cause any serious safety issues, and participants did not reject the cells. Most side effects were mild to moderate and resolved on their own. This suggests the treatment is generally safe for humans.12345
Why do researchers think this study treatment might be promising for retinitis pigmentosa?
Unlike the standard treatments for retinitis pigmentosa, which mainly focus on managing symptoms and slowing disease progression, jCell (Famzeretcel) offers a regenerative approach. This treatment is unique because it involves a single injection of 8.8 million retinal progenitor cells directly into the eye, potentially replenishing damaged cells and restoring vision. Researchers are excited about jCell because it targets the underlying cause of retinal degeneration, which could lead to significant improvements in vision, offering hope for a condition that currently has no cure.
What evidence suggests that jCell might be an effective treatment for retinitis pigmentosa?
Research shows that jCell, also known as famzeretcel, may improve vision in people with retinitis pigmentosa (RP). In earlier studies, patients who received one injection of jCell showed possible improvements in vision sharpness compared to those who did not receive it. Some studies indicate that these improvements might be more noticeable with higher doses. In this trial, participants will receive either an 8.8 million jCell injection or a sham-treated control. The treatment proved to be safe and well-tolerated, with no serious side effects reported. Although the results are still early, they suggest that jCell might help some people with RP see better.14567
Who Is on the Research Team?
Henry Klassen, MD, PhD
Principal Investigator
jCyte, Inc
Are You a Good Fit for This Trial?
This trial is for adults with Retinitis Pigmentosa (RP), a genetic eye condition that leads to vision loss. Participants must be eligible based on specific health criteria not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravitreal injection of 8.8 million retinal progenitor cells or a sham injection
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of visual function
What Are the Treatments Tested in This Trial?
Interventions
- jCell (Famzeretcel)
Find a Clinic Near You
Who Is Running the Clinical Trial?
jCyte, Inc
Lead Sponsor