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Stem Cell Therapy
Stem Cell Implantation for Retinitis Pigmentosa
Phase 1
Recruiting
Led By David Liao, MD, PhD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
4. Participant will be medically able to undergo ophthalmic surgery.
Participant with diagnosis of retinitis pigmentosa
Timeline
Screening 3 weeks
Treatment Varies
Follow Up performed 7 times over 15 months
Awards & highlights
Study Summary
This trial is examining the safety of transplanting a type of stem cell, called neural progenitor cells, into the subretinal space of patients with Retinitis Pigmentosa. These cells have been derived to become astrocytes, which are a type of neuronal cell. The investigational treatment has been tested in animals, but it has not yet been tested in people. In this study, the investigators want to learn if these cells are safe to transplant into the subretinal space of people.
Who is the study for?
Adults diagnosed with Retinitis Pigmentosa (RP) who have visual acuity of 20/200 or worse, or a central visual field of 40 degrees diameter or less. They must be able to undergo eye surgery and sign informed consent. Excluded are those on certain medications, with allergies to specific antibiotics, recent substance abuse, ocular abnormalities that could affect the study's outcome, systemic diseases affecting ocular function, pregnant/nursing women, and unwillingness to use contraception.Check my eligibility
What is being tested?
The trial is testing the safety of implanting CNS10-NPC cells into the subretinal space in RP patients. These neural progenitor cells are designed to become astrocytes in hopes of treating RP. This is an initial human test following animal studies.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical risks associated with ophthalmic surgery such as infection, inflammation, vision changes or loss. There might also be immune reactions due to cell transplantation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am medically cleared for eye surgery.
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I have been diagnosed with retinitis pigmentosa.
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I have limited side vision.
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I have been diagnosed with retinitis pigmentosa.
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I have been diagnosed with retinitis pigmentosa.
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I have limited side vision.
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I have symptoms of retinitis pigmentosa.
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I am 18 years old or older.
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I have a history of night blindness.
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I have changes in the color of my retina.
Select...
I have been diagnosed with retinitis pigmentosa.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ performed 7 times over 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~performed 7 times over 15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety as evaluated by incidence of Adverse Events (AE) and Serious Adverse Events (SAE) and their relationship to the intervention
Safety, as evaluated by changes in Donor Specific Antibodies
Safety, as evaluated by changes in Spectral Domain Optical Coherence Tomography (SD-OCT)
+5 moreSecondary outcome measures
Best Corrected Visual Acuity
Change in rate of vision field loss
Electroretinography (ERG)
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Visual acuity between 20/80 and 20/200
Single, unilateral, subretinal injection of 1,000,000 CNS10-NPC (n=10)
Group II: Group 1BExperimental Treatment1 Intervention
Visual acuity of 20/200 or worse
Single, unilateral, subretinal injection of 1,000,000 CNS10-NPC (n=3)
Group III: Group 1AExperimental Treatment1 Intervention
Visual acuity of 20/200 or worse
Single, unilateral, subretinal injection of 300,000 CNS10-NPC (n=3)
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,841 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
63 Previous Clinical Trials
3,132 Total Patients Enrolled
3 Trials studying Retinitis Pigmentosa
142 Patients Enrolled for Retinitis Pigmentosa
David Liao, MD, PhDPrincipal InvestigatorRetina-Vitreous Associates Medical Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am medically cleared for eye surgery.I agree to use contraception for at least 6 months after surgery.I have not had a serious illness or infection in the last 28 days.I have been diagnosed with retinitis pigmentosa.I am 18 or older and can sign the consent form.I have limited side vision.I cannot have anesthesia due to health reasons.I do not have any other illnesses that could affect my eyes or immune system.I have had cancer or a positive cancer test within the last 5 years.I can travel to the study center and understand the consent without mental impairments.I have been diagnosed with retinitis pigmentosa.I have not had eye steroid treatments in the last 4 months.I am not allergic to any medications or substances used in this study.I have been diagnosed with retinitis pigmentosa.I have a history of HIV or hepatitis A, B, or C.Waxy pallor, sometimes seen on the optic disc, is an electrophysiologic sign of rod dysfunction on full field electroretinography.Group 1 will have worse vision than Group 2.I have not had eye surgery or laser treatment in the last 12 weeks.My eyes are healthy and have no history of conditions that could complicate surgery.I am willing to use effective contraception if I can become pregnant.I do not have eye conditions like severe cataracts or glaucoma that affect vision tests.I am on or expect to be on steroids for more than a week.I am not currently on immunosuppressant therapies and have no contraindications to them.I have limited side vision.I have symptoms of retinitis pigmentosa.I haven't taken any prescription retinoids or macula-affecting drugs in the last 6 months.I am 18 years old or older.I have swelling in the central part of my retina.I have G6PD deficiency.I have a history of night blindness.I have changes in the color of my retina.I am medically cleared for eye surgery.I have been diagnosed with retinitis pigmentosa.Group 1 participants will have a central visual field with a diameter of 40 degrees or lessI cannot have my pupils dilated due to a medical condition.I am currently pregnant.I do not have major eye problems that would affect surgery or study results.I am not nursing or planning to nurse for 6 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1A
- Group 2: Group 1B
- Group 3: Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Retinitis Pigmentosa Patient Testimony for trial: Trial Name: NCT04284293 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are there in the current clinical trial?
"Indeed, the information available on clinicaltrials.gov confirms that this study is actively recruiting participants. The posting of this trial was initially launched in July 2021 and the data was last updated at the end of December 2021. This medical experiment seeks to enroll 16 people from a single site."
Answered by AI
Is the FDA sanctioning CNS10-NPC embedment?
"As this is a Phase 1 trial, the safety of CNS10-NPC implantation was given an assessment score of 1 due to limited data on efficacy and safety."
Answered by AI
Does this research endeavor still have room for participants?
"Affirmative. Clinicaltrials.gov indicates that this medical trial is in the process of recruiting volunteers, having first been posted on July 22nd 2021 and most recently updated on December 21st 2021. Currently 16 patients are being sought from a single location."
Answered by AI
Who else is applying?
What state do they live in?
Other
Florida
Texas
Arizona
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Retina-Vitreous Associates Medical Group
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
Desperate for anything. I’m willing to try anything at this point. I have been told there is no cure and with time my vision will slowly decline.
PatientReceived no prior treatments
ive tried to do everything possible to slow the condition, i was diagnosed at 36 , now 52 & have grand children to play with.
PatientReceived no prior treatments
Hi my name is Cynthia Mendez, I was born with RP. I have experienced the difficulties and the challenges of having this eye condition. Unfortunately one of my children inherited my eye condition and we are both looking into a clinical trial. As a mother you want the best for your child, and this clinical trial is a glimpse of hope me and my son.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How will I know if I qualify?
PatientReceived no prior treatments
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