hRPC for Retinitis Pigmentosa

(hRPCRP Trial)

Recruiting at 4 trial locations

Overseen By Vince Holmes

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ReNeuron Limited

Must not be taking: Immunosuppressive agents

Disqualifiers: Ocular disease, Retinal detachment, High myopia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cell therapy where special cells are injected into the eye to help people with retinitis pigmentosa, a disease that causes vision loss. The goal is to see if these cells can repair or replace damaged parts of the eye.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have used systemic immunosuppressive agents (like corticosteroids) in the 6 months before treatment.

Is hRPC treatment for Retinitis Pigmentosa safe for humans?

A systematic review of various treatments for Retinitis Pigmentosa, including pharmacological and nonpharmacological options, found that all treatments were safe, although they did not significantly improve visual function. ^{1 2 3 4 5}

Who Is on the Research Team?

Jason Comander, MD

Principal Investigator

Massachusetts Eye and Ear Infirmary (MEEI)

Vince Holmes

Principal Investigator

ReNeuron Limited

Are You a Good Fit for This Trial?

Inclusion Criteria

You are physically healthy enough to have a surgery called vitrectomy and receive an injection under your retina.

Have ability to give written informed consent as evidenced by signature on the subject consent form

Be able to complete the entire microperimetry test, and demonstrate adequate fixation and consistency between baseline readings such that the accuracy of both baseline and follow on testing should enable the detection of clinically significant changes in retinal sensitivity

Exclusion Criteria

High myopia (>6 diopters) in the study eye

You have an eye condition or problem that would make it difficult to accurately evaluate your eye during the study.

You have had a surgery called vitrectomy in the eye being studied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subretinal injection of hRPC cells in one eye

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and tolerability, with detailed ophthalmic examinations and imaging

24 months

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• hRPC

How Is the Trial Designed?

Group I: human retinal progenitor cells (hRPC) Experimental Treatment 1 Intervention

Single subretinal administration of human retinal progenitor cells (hRPC)

Who Is Running the Clinical Trial?

ReNeuron Limited

Lead Sponsor

Trials

8

Recruited

240+

Published Research Related to This Trial

The study successfully registered 1890 patients with retinitis pigmentosa in Denmark, achieving an overall completeness of about 80%, which improved significantly for more recent birth cohorts.

The majority of patients (73%) were diagnosed with high confidence, and the data collected is valuable for ongoing epidemiological, clinical, and genetic research into the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A population survey of retinitis pigmentosa and allied disorders in Denmark. Completeness of registration and quality of data. Haim, M., Holm, NV., Rosenberg, T.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Readability, Content, and Accountability Assessment of Online Health Information for Retinitis Pigmentosa & Retinitis Pigmentosa Treatment Options. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Using crowdsourcing to understand patients attitudes toward a clinical trial for retinitis pigmentosa requiring 4 years of participation. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Early therapeutic trials for retinitis pigmentosa]. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of Randomized Clinical Trials on Safety and Efficacy of Pharmacological and Nonpharmacological Treatments for Retinitis Pigmentosa. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

A population survey of retinitis pigmentosa and allied disorders in Denmark. Completeness of registration and quality of data. [2019]