Last updated on February 2019

Safety and Tolerability of hRPC in Retinitis Pigmentosa

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Retinitis Pigmentosa
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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