News Summary
jCyte, Inc. has initiated the JC02-88 clinical trial to evaluate the safety and efficacy of jCell (famzeretcel) for patients suffering from retinitis pigmentosa. The trial involves a higher dose of jCell and aims to enroll up to 60 participants aged 18 to 60. This innovative treatment may offer new hope for individuals with various genetic subtypes of the condition, which affects millions globally. Experts in the field express excitement about this milestone and its potential impact on advancing care for retinal degenerative disorders.
Newport Beach, California – jCyte, Inc. has begun enrolling and treating the first patients in their JC02-88 clinical trial, aimed at evaluating the safety and efficacy of jCell (famzeretcel) for individuals suffering from retinitis pigmentosa (RP). This trial is critical as it explores a new potential treatment for a condition that affects millions worldwide.
The currently studied jCell dose is approximately 50% higher than the highest doses previously administered in jCyte’s clinical trials, marking a significant step in the development of this therapy. The clinical study intends to enroll up to 60 patients aged between 18 to 60 years with any genetic subtype of RP. Participants will be randomly assigned to receive either the jCell treatment or a sham treatment (control) and will be monitored for safety and changes in vision over a six-month duration.
Retinitis pigmentosa is a rare genetic disorder characterized by a gradual loss of rod and cone photoreceptors in the retina, leading to progressive vision loss. Typically diagnosed in adolescence, this debilitating condition can result in legal blindness by middle age. Reports estimate that RP affects roughly 2 million people globally, including around 100,000 individuals in the U.S.
John Sholar, the CEO of jCyte, indicated that the initiation of patient dosing is an important milestone, heralding a potential breakthrough for patients who currently have limited options for treatment. The jCell treatment is designed to restore vision in patients with retinitis pigmentosa, potentially offering hope to those with different genetic subtypes of the disease.
Excitement for the trial and its potential impact on the RP community has been expressed by experts in the field. Henry Klassen, MD, PhD, co-founder and president of jCyte, highlighted the significance of this achievement in the quest for a viable treatment for RP. The trial is also receiving collaborative support from several esteemed organizations, such as the Gavin Herbert Eye Institute, the UCI GMP Facility, Lexitas, and the California Institute for Regenerative Medicine (CIRM).
This phase 2 trial specifically assesses the safety, tolerability, and efficacy of a single injection containing 8.8 million jCells. All participants receiving treatment will be monitored at the UC Irvine Gavin Herbert Eye Institute, ensuring comprehensive care and oversight throughout the trial’s duration.
In addition, a follow-up extension study is anticipated to allow for longer-term monitoring and treatment possibilities for those who were administered the sham control. Currently, there are no FDA-approved therapies available for approximately 99% of RP patients, which heightens the importance of advancing research in this area.
jCyte is recognized as a clinical-stage biotechnology company committed to developing jCell for retinitis pigmentosa and other retinal degenerative disorders. The treatment has already received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, reinforcing its potential significance in regenerative medicine.
Ongoing research and treatment initiatives at the Gavin Herbert Eye Institute continue to push the boundaries in the field of eye diseases. Likewise, Lexitas, a clinical research organization specializing in ophthalmology, brings over 14 years of experience to this critical study. The CIRM contributes substantially with over 150 active stem cell programs, emphasizing its dedication to advancing cellular medicine.
The enrollment of the first patients in the JC02-88 trial may mark a turning point for those diagnosed with retinitis pigmentosa, offering avenues for innovative treatments and paving the way for future advancements in the care of retinal degenerative disorders.
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Additional Resources
- Business Wire: jCyte Inc. Announces First Patients Treated in JC02-88 Trial for Retinitis Pigmentosa
- Orange County Business Journal: jCyte Inks $252M Licensing Deal
- MedCity News: Gene Therapy Biotech Startup for Inherited Retinal Disease
- Bioworld: Series A Backers See Ray of Hope, $100M for Retinal Diseases
- Business Wire: jCyte Inc. Announces Positive Pre-Phase 3 FDA Type B Meeting
- Wikipedia: Retinitis Pigmentosa
- Google Search: Retinitis Pigmentosa
- Google Scholar: Retinitis Pigmentosa
- Encyclopedia Britannica: Retinitis Pigmentosa
- Google News: Retinitis Pigmentosa

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