Boston, Massachusetts 02114


Purpose:

hRPC is a cell therapy for retinitis pigmentosa. This is a first-in-human, dose escalation study in which participants with retinitis pigmentosa will receive a single subretinal injection of hRPC cells in one eye to evaluate safety and tolerability. Participants will be followed for one year to evaluate the safety and tolerability of hRPC Additional testing will seek to establish any preliminary efficacy from hRPC.


Study summary:

This is a first-in-human open label phase I/II dose-escalation study in which participants with retinitis pigmentosa will receive a single uni-ocular subretinal implantation of one of three doses of hRPC. Treated eyes will be carefully monitored for any ocular or systemic adverse events for 1 year. Testing will comprise a series of detailed ophthalmic examinations and imaging together with blood testing and systemic evaluations, as necessary Ophthalmic testing will also be evaluated for any preliminary efficacy signal.


Criteria:

Inclusion Criteria: - Adult male or female over 18 years of age. - Clinical diagnosis of RP, based upon one or more of the following: clinical features, electrophysiological measures and genetic testing, if available (genetic confirmation is not obligatory). - Best corrected Visual acuity of 20/200 or worse in the study eye (N.B. in patients with differing acuities between eyes, the worse eye will be enrolled as the study eye). - Medically able to undergo vitrectomy and subretinal injection, a surgery which may require general anesthesia. - Good general health as defined by: - Normal serum chemistry and hematology. Out of normal range laboratory findings deemed not clinical significant are acceptable. - No history of malignancy, except non-melanoma skin cancer; pre-malignant conditions and cancer in situ. - Negative serology for human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) - Female patients of child-bearing potential must use a reliable method of contraception (e.g. oral contraceptive and condom, intra-uterine device (IUD) and condom, diaphragm with spermicide and condom) during the study. - Females of childbearing potential must have a confirmed negative pregnancy test at time of treatment. - Males must be willing to use barrier and spermicide contraception during the study. - Ability to give written informed consent as evidenced by signature on the patient consent form, to communicate well with the investigator and to comply with the expectations of the study. Exclusion Criteria: - The presence of ocular disease or ocular media opacity, which in the opinion of the investigator, precludes accurate evaluation during the study. - Prior vitrectomy in the study eye - Patients with a history of amblyopia will be excluded - High myopia (>6 diopters) in the study eye - Cataract surgery in the study within 3 months - Participation within 6 months in any clinical trial involving a drug or device treatment - No prior stem cell injections in any part of the body - Use of systemic immunosuppressive agents in the six months prior to treatment


NCT ID:

NCT02464436


Primary Contact:

Principal Investigator
Eric Pierce
Massachusetts Eye and Ear Infirmary (MEEI)

Eric Pierce, MD
Phone: 617-573-6060
Email: ophthalmologyclinicalresearch@meei.harvard.edu


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States

Eric Pierce, MD
Phone: 617-573-6060
Email: ophthalmologyclinicalresearch@meei.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.