CLINICAL TRIAL

Intravitreal autologous CD34+ cells for Retinitis Pigmentosa

Recruiting · 18+ · All Sexes · Sacramento, CA

This study is evaluating whether a stem cell injection is safe and feasible for people with retinitis pigmentosa.

See full description

About the trial for Retinitis Pigmentosa

Eligible Conditions
Retinitis Pigmentosa · Retinitis

Treatment Groups

This trial involves 2 different treatments. Intravitreal Autologous CD34+ Cells is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Intravitreal autologous CD34+ cells
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
1. Age >18 years of age 2. Visual Acuity at Presentation of 20/100 to Counting Fingers or constriction of peripheral visual field 360 degrees to <10 degrees by perimetry if BCVA is better than 20/100, duration of vision loss > 3 months 3. Vision loss due to retinitis pigmentosa 4. The study eye has the worse visual acuity or peripheral constriction. 14. Able and willing to sign consent 15. Able to keep follow-up appointments for at least 6 months
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Intravitreal autologous CD34+ cells will improve 2 primary outcomes and 5 secondary outcomes in patients with Retinitis Pigmentosa. Measurement will happen over the course of Baseline.

Feasibility of intravitreal injection of autologous CD34+ cells
BASELINE
Number of CD34+ cells harvested for intravitreal injection
BASELINE
Microperimetry
1 MONTH
Change in percent reduced sensitivity from baseline
1 MONTH
National Eye Institute Vision Questionnaire
1 MONTH
Change in Vision Questionnaire compared to baseline
1 MONTH
Electroretinography
1 MONTH
Change in a and b wave amplitude in study eye from baseline
1 MONTH
Visual Field
1 MONTH
Change in visual field area in study eye from baseline
1 MONTH
Best corrected visual acuity
1 MONTH
Change in number of letters read in study eye from baseline
1 MONTH
See More

Who is running the study

Principal Investigator
S. P.
Prof. Susanna Park,, MD PhD
University of California, Davis

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is retinitis pigmentosa?

Retinitis pigmentosa is a genetic disease that causes a gradual deterioration of the central and/or peripheral vision. It generally causes blindness because the brain does not receive enough light which is needed to see clearly.\n

Anonymous Patient Answer

What are the signs of retinitis pigmentosa?

The appearance of RP may vary from mild retinal problems to blindness. Retinal screening in patients with unexplained intraocular lens dislocation should be offered, either prior to or during cataract surgery.

Anonymous Patient Answer

What causes retinitis pigmentosa?

The retinal cells die because of a disorder in the retinal tissue. The retinal cells that die can produce new retinal cells that do not function properly. In some cases, the eyes of affected individuals may have little or no color.\n

Anonymous Patient Answer

How many people get retinitis pigmentosa a year in the United States?

One-fourth of individuals who are living at age 40 and older have RP. A high percentage (23%) of the U.S. population was found to have a first-degree relative with RP, and another quarter of the population is likely to be at risk of RP or RP-affected offspring in the future.

Anonymous Patient Answer

Can retinitis pigmentosa be cured?

The clinical manifestations of RP can vary greatly between persons, with no known "cure." However, treatment options have improved, which can significantly reduce the devastating effects of RP.

Anonymous Patient Answer

What are common treatments for retinitis pigmentosa?

Genetic counselling can be beneficial to patients affected by retinitis pigmentosa, as it will help to inform the patient about all the chances to find a disease gene in their family. On the other hand, the use of new therapies will help to increase the life expectancy of these patients and reduce their quality of life.\n

Anonymous Patient Answer

How serious can retinitis pigmentosa be?

Patients with minimal vision problems will need to use care providers more frequently and have worse health problems than will they otherwise. The most pressing concern is not to stop any of the patients, if vision is well enough stabilized, from reaching their full potential, as health complications are often treatable.

Anonymous Patient Answer

Is intravitreal autologous cd34+ cells typically used in combination with any other treatments?

Intravitreal infusion of autologous CD34(+) cells seems to provide significant benefits mainly in the management of macula edema and visual gains, particularly in the treatment of PCME in nadroparin-treated eyes, and is often used in combination with other therapies.

Anonymous Patient Answer

Have there been any new discoveries for treating retinitis pigmentosa?

There have still been no novel discoveries in the treatment of RP for several decades. It is possible that there will be such a breakthrough with the discovery in a new target gene and novel treatment. Novel treatments, including gene therapy, stem cells, antibodies and drugs for each gene defect have the possibility of curing or preventing blindness; however, for many of the other diseases, it will still be quite a time before a new treatment can be found.

Anonymous Patient Answer

What are the common side effects of intravitreal autologous cd34+ cells?

Autologous CD34+ cells are a powerful tool for retinal cell delivery. The high number of CD34+ cells can lead to the induction of toxic effects. The injection of autologous CD34+ cells induced an increase in VEGF and sFlt-1, thus inducing omentalizing vasculopathy.

Anonymous Patient Answer

What does intravitreal autologous cd34+ cells usually treat?

It's important for the clinician to be sure of the correct cell therapy before injection. Otherwise, the eye is in trouble. Intravitreal injection of autologous CD34+ cells has proven to be an effective strategy for the treatment of macular edema.

Anonymous Patient Answer

Have there been other clinical trials involving intravitreal autologous cd34+ cells?

Intravitreal autologous mononuclear cells are promising for future treatment of retinal neovascularization in retinitis pigmentosa. Recent findings show the feasibility of autologous mononuclear cells injection intravitreal for the treatment of proliferative eye diseases.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Retinitis Pigmentosa by sharing your contact details with the study coordinator.