Safety of Repeat Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Intervention: human retinal progenitor cells
Intervention description: single intravitreal injection of 6.0 million human retinal progenitor cells (hRPC)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the safety of repeat injection of human
      retinal progenitor cells (jCell) in adult subjects with RP that have previously been treated
      with jCell.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing to give written informed consent, able to make the required study visits and
             follow study protocol instructions.

          2. Completed the 12 months of follow up in the subject's most recent jCell study and did
             not withdraw from the study for any reason.

          3. Adequate organ function:

               -  blood counts (hematocrit, Hgb, WBC, platelets and differential) within normal
                  range, or if outside of normal range, not clinically significant as judged by the
                  investigator

               -  liver function: alanine transaminase [ALT] and aspartate transaminase [AST] ≤2
                  times the upper limit of the normal range

               -  total bilirubin ≤1.5 times the upper limit of the normal range

               -  renal function: serum creatinine ≤1.25 times the upper limit of the normal range

          4. A female patient of childbearing potential (not surgically sterilized and less than
             one year postmenopausal) must have a negative pregnancy test (urine human chorionic
             gonadotropin) at entry (prior to injection) and must have used medically accepted
             contraception for at least one month prior to treatment. Women of childbearing
             potential and men must be advised to use a medically accepted method of contraception
             for at least 12 months following treatment.

        Exclusion Criteria:

          1. Malignancy, end-stage major organ disease (heart failure, significant arrhythmias,
             stroke or transient ischemic attacks, diabetes, immunosuppressive or autoimmune state,
             major psychiatric disorder, epilepsy, thyroid disease, COPD, renal failure, or any
             chronic systemic disease requiring continuous treatment with systemic steroids,
             anticoagulants or immunosuppressive agents.

          2. History of eye disease other than RP that impairs visual function, including retinal
             vascular disease, elevated intraocular pressure/glaucoma, severe posterior uveitis,
             clinically significant macular edema, media opacity precluding visual exam, amblyopia
             and/or longstanding constant strabismus, as well as patients who require other
             intravitreal therapies

          3. Allergy to penicillin or streptomycin.

          4. Adverse reaction to DMSO.

          5. Unable or unwilling to undergo pupil dilation, topical anesthesia or any
             protocol-required procedure.

          6. Women who are nursing or who are planning to nurse during the 12 months that would
             follow study treatment.

          7. Any circumstance that in the opinion of the investigator, would interfere with
             participation in, or compliance with the study protocol

          8. Treatment with corticosteroids (systemic, periocular or intravitreal) or any other
             non-approved, experimental, investigational or neuroprotectant therapy (systemic,
             topical, intravitreal) in either eye within 90 days of planned second injection.

          9. Cataract surgery within three months prior to treatment or anticipated to need
             cataract surgery within a year of treatment