JC02-88 Study

jCyte is seeking up to approximately 60 patients with retinitis pigmentosa (RP) to take part in its latest clinical study, called JC02-88. The purpose of this Phase 2 study is to assess the safety and tolerability of a single 8.8 million cell injection of jCell, a treatment designed to help improve vision in patients with RP. The study also aims to evaluate the potential effectiveness of jCell in improving vision and quality of life over a 6-month period. The study will be conducted in Southern California and is expected to begin in the first quarter of 2025 and finish before the end of 2025. 

Each participant will receive either one jCell treatment or a sham (looks and feels like the study drug treatment but no drug is actually administered) treatment and will be assessed for safety and changes in vision at select times during the 6-month study. There is more than a 50/50 chance of receiving jCell rather than the sham treatment.

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Key Requirements

Adults with any form of RP (i.e., regardless of genetic cause) who live in Southern California, may qualify for the study if they meet certain study requirements. The key requirements* include, but are not limited to, the following:

  • Age 18 - 60
  • Confirmed diagnosis of retinitis pigmentosa
  • Vision between 20/80 and 20/800 in the study eye
  • Remaining central island visual field diameter should be at least 8° in the study eye 
  • No major poorly controlled general health issues other than retinitis pigmentosa
  • Commitment to travelling to Irvine, CA three to four times over a 6-month period (reimbursement of travel expenses for study-related assessments is provided for participants and a companion)
  • No prior participation in a jCyte study 
  • No prior participation in ANY clinical trial within the last 6 months EXCEPT for studies evaluating N-acetyl cysteine (NAC), in which case participation in this jCell study is still possible
  • No history of OCULAR treatment with any non-approved, experimental retinal therapy or device in either eye except for NAC treatment, which must to be stopped at least 7 days before joining the study
  • Not pregnant or planning to become pregnant during the 6-month study period and for 6 months following the study – for a total of 12 months

Follow-up

Patients participating in JC02-88 will be required to attend 10 in-person visits and have one remote phone call consultation over the 6-month study period. Three to four of the in-person visits will require travel to Irvine, CA. If the JC02-88 study results are good, a subsequent follow-up (“extension”) study is planned (JC02-88E). The JC02-88E study will give those who received the sham treatment the opportunity to receive jCell and have their eye health and vision changes monitored. Those who received jCell in the JC02-88 study will also have the opportunity to participate in the extension study for longer-term monitoring but will not receive a second jCell treatment. 

If you wish to be considered for this study, and you live in Southern California, please talk to your retina doctor about whether you may qualify for the study. Your retina doctor will require the following test results to determine your potential eligibility:

  1. Electroretinography (ERG) results that support the diagnosis of RP
  2. Best corrected visual acuity (BCVA) results from within the last 12 months

*The key requirements shown here represent critical eligibility criteria at a high level. Official study eligibility will be determined based on the explicit and precise requirements contained in the protocol