A Phase 2 Study of the Safety of Repeat Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- jCyte, Inc
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Safety of Intravitreal Injection of hRPC
研究概览
简要总结
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.
详细描述
This is a prospective, multi-center, single arm, Phase 2 study of human retinal progenitor cells (jCell) for the treatment of retinitis pigmentosa (RP). The study will include only subjects previously treated with jCell.
To assess reinjection of a previously treated eye, subjects who have previously been treated with jCell and desire a second treatment in the same eye will be enrolled. Subjects must have completed at least 12 months of follow up since the prior injection of jCell. Subjects who have had both eyes previously treated with jCell will only have one eye retreated; the eye to be retreated will preferably be the better seeing eye, but exceptions may be made by the study investigator, taking into consideration BCVA, prior response to treatment, and any other medical conditions that may indicate which eye is the best candidate for retreatment. Subjects will be followed for 12 months for safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to give written informed consent, able to make the required study visits and follow study protocol instructions.
- •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.
- •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
- •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.
排除标准
- •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.
- •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
- •Allergy to penicillin or streptomycin.
- •Adverse reaction to DMSO.
- •Unable or unwilling to undergo pupil dilation, topical anesthesia or any protocol-required procedure.
- •Women who are nursing or who are planning to nurse during the 12 months that would follow study treatment.
- •Any circumstance that in the opinion of the investigator, would interfere with participation in, or compliance with the study protocol
- •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.
- •Cataract surgery within three months prior to treatment or anticipated to need cataract surgery within a year of treatment
结局指标
主要结局
Safety of Intravitreal Injection of hRPC
时间窗: 12 months
Assessed by percentage of subjects with treatment emergent adverse events
次要结局
- Low Luminance Mobility Test (LLMT)(12 months)
- Best Corrected Visual Acuity (BCVA)(12 months)
- Kinetic Visual Field Area(12 months)
- Contrast Sensitivity (Peak)(12 months)