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 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 is being conducted in Southern California and is expected to finish in 2026.

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.

This page is for Healthcare Professionals. Please provide the information below for access.

 

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 traveling 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

For more details, please visit trial NCT06912633 on clinicaltrials.gov.

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 positive, a subsequent follow-up (“extension”) study is planned (JC02-88E). The JC02-88E study will provide 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 24 months

Current active clinical sites and contact emails are listed below. You may also reach out to jCyte at info@jcyte.com.

University of California at Irvine
Gavin Herbert Eye Institute
850 Health Science Road
Irvine, CA 92697

Principal Investigator:
Mitul Mehta, MD, MS 

Study Coordinators:
Maximillian Chu
maximicc@hs.uci.edu

Rosie Magallon
rmagallo@hs.uci.edu

Jaime Toledo
toledocj@hs.uci.edu

University of California at San Diego
Shiley Eye Institute
9415 Campus Point Drive
La Jolla, CA 92093

Principal Investigator:
Shyamanga Borooah, MD

Study Coordinators:
Iliana Molina
imolina@health.ucsd.edu

Eric Hernandez
eohernandez@health.ucsd.edu

Retina Vitreous Associates Medical Group
9001 Wilshire Blvd, Ste 301
Beverly Hills, CA 90211

Principal Investigator:
David Liao, MD

Study Coordinator:
Eric Jimenez
ejimenez@laretina.com

California Retina Consultants
Affiliated Member of Retina Consultants of America
5555 Business Park South, Suite 220
Bakersfield, CA 93309

PRINCIPAL INVESTIGATOR:
Dante Pieramici, MD

Study Coordinator:
Luis Lopez
luis.lopez@californiaretina.com

*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