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 6.0 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 expected to finish in 2026. Applicable travel costs associated with study visits will be covered and patients will be compensated for participating in the study.

Each participant will receive either one jCell treatment or a sham (looks like the study drug treatment but no needle is used and no drug is actually administered) treatment and will be assessed for safety and changes in vision at select times during the 6-month study.

Email or call us directly at jCyte so we can help connect you to the proper clinic:

Email: info@jcyte.com
Phone: (949) 688-1816

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) 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 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 (including jCell) or device in either eye except for NAC treatment, which must 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, 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) or genetic testing results that support the diagnosis of RP
  2. Best corrected visual acuity (BCVA) results from within the last 24 months

If you are interested in participating in this study, please reach out to jCyte via email at info@jcyte.com or via phone at (949) 688-1816, so that we may assist you in being connected with the clinical site most appropriate for you. Below are participating sites in the study.

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
Rosie Magallon
Jaime Toledo

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:
Brandy Plaat

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

Principal Investigator:
David Liao, MD

Study Coordinator:
Eric Jimenez

Retina Consultants Medical Group
3 Parkcenter Drive, Suite 100
Sacramento, CA 95825

PRINCIPAL INVESTIGATOR:
David G. Telander, MD, PhD

Study Coordinator:
Joshua Greenwood

Illinois Retina Associates
610 South Maple Ave, Suite 4000
Oak Park, IL 60304

Principal Investigator:
Mathew W. MacCumber, MD, PhD

Study Coordinator:
Sara Montgomery

Retina Consultants of Texas: Bellaire Retina Center
4460 Bissonnet Street, Suite 200
Bellaire, TX 77401

Principal Investigator:
Kenneth Fan, MD

Study Coordinator:
Rebbecca Taing

Vitreoretinal Consultants of NY
1600 Stewart Ave, Suite 411
Westbury, NY 11590

Principal Investigator:
Philip J. Ferrone, MD

Study Coordinator:
Ewelina Lokaj

The Retina Group of Washington
8270 Willow Oaks Corporate Dr, Suite 600
Fairfax, VA 22031

Principal Investigator:
Joshua D. Levinson, MD

Study Coordinators:
Katrina Arias & Rachel Rivera

Retina Consultants of Texas
21 Spurs Ln, Suite 100A 
San Antonio, TX 78240

Principal Investigator:
Jeremiah Brown, Jr., M.D. 

Study Coordinator:
Lydia Adams

NJ Retina
628 Cedar Ln
Teaneck, NJ 07666

Principal Investigator:
Luis A. Gonzalez, M.D., M.P.H.

Study Coordinator:
Benjamin Outten

Vitreo Retinal Associates, P.A.
4340 West Newberry Road, Suite 201
Gainesville, FL 32607

Principal Investigator:
Christine N. Kay, MD

Study Coordinators:
Jing Zhang & Hailey Ahrens

Georgia Retina
833 Campbell Hill Street, Suite 300
Marietta, GA 30060

Principal Investigator:
David S. Chin Yee, MD

Study Coordinator:
Blair Symington

Associated Retina Consultants
1750 E Glendale Ave
Phoenix, AZ 85020

Principal Investigator:
Benjamin Bakall, MD, PhD

Study Coordinator:
Jillian Bollinger

Bay Area Retina Associates
365 Lennon Lane, Suite 250 & 270
Walnut Creek, CA 94598

Principal Investigator:
Dr. Roger Goldberg

Study Coordinator:
Luis Monsalve

*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