EUCTR2019-004547-77-GB进行中（未招募）1 期
First-in-human Phase I/IIa, Open-Label, Prospective Study of the Safety and Tolerability of Subretinally Transplanted Human Retinal Progenitor Cells (hRPC) in Subjects with Retinitis Pigmentosa (RP)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ReNeuron Ltd
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must satisfy all of the following criteria to be included in the study:
- •a) Have ability to give written informed consent as evidenced by signature on the subject consent form
- •b) Be adult male or female over 18 years of age
- •c) Have clinical diagnosis of RP, based upon one or more of the following: clinical features, medical imaging, electrophysiological measures and genetic testing, if available. Genetic confirmation is not obligatory.
- •d) Have Best Corrected ETDRS visual acuity of 35 letters or less (approximately 20/200 or worse) in the study eye for cohorts 1-5; have Best Corrected ETDRS visual acuity of 8 letters (approximately 20/800) to 63 letters (approximately 20/63) in the study eye for cohort 6-8, and Best Corrected ETDRS visual acuity of 8 letters (approximately 20/800) to 68 letters (approximately 20/50) for cohorts 9 and onwards
- •e) 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 up testing should enable the detection of clinically significant changes in retinal sensitivity.
- •f) Be medically able to undergo vitrectomy and subretinal injection.
- •g) Have good general health as defined by:
- •i. Normal serum chemistry and hematology. Out of normal range laboratory findings deemed not clinically significant (at the discretion of the Investigator) are acceptable.
- •ii. No history of malignancy, except non-melanoma skin cancer; pre-malignant conditions and cancer in situ.
- •iii. Negative serology for human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV)
- •iv. Medically fit enough to undergo surgery which may require general anesthesia as well as medically fit to undergo a short perioperative course of systemic corticosteroid therapy
- •v. Free of any other systemic condition that in the opinion of the Investigator may have an impact on the safety of the subject, conduct of study procedures, or integrity of study data (e.g. severe cardiovascular or respiratory disease; poorly controlled diabetes; significant psychiatric impairment)
- •h) Females of childbearing potential must have a confirmed negative pregnancy test at Visits 1 and 3 and be willing to use acceptable method of contraception (e.g. oral contraceptive and condom, intra-uterine device (IUD) and condom, diaphragm with spermicide and condom) for the duration of this study
- •i) Males must be willing to use to use an acceptable method of contraception (e.g. barrier and spermicide) for the duration of this study; unless they have been surgically sterilized with confirmed azoospermia.
- •j) Be willing and able to attend all scheduled clinical assessments, ability to communicate well with the Investigator and to comply with the expectations of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •Subjects must not have any of the following criteria:
- •a) Exhibits a difference in ETDRS BCVA of 15 letters of more in either eye between any of the baseline visits.
- •b) Exhibits a difference in ETDRS BCVA of 20 or more letters between eyes at the time of any of the screening or baseline visits attributed to asymmetry in the progression of RP.
- •c) Presence of ocular disease or ocular media opacity in the study eye, which in the opinion of the Investigator, will preclude an accurate evaluation at any time during the study.
- •d) History of any retinal and/or macular disease other than RP (e.g. retinal detachment) that in the opinion of the Investigator may have an impact on the safety of the subject, conduct of study procedures, or integrity of study data. Specifically, subjects in whom significant pre-existing vitreoretinal pathology might influence visual acuity outcomes should be excluded.
- •e) Active ocular infection or inflammation, or any history of intraocular inflammation, that would expose subject to risk during or following surgery
- •f) Prior vitrectomy in the study eye
- •g) A history of amblyopia in the study eye
- •h) High myopia (>6 diopters) in the study eye
- •i) Cataract surgery in the study eye or ocular surgery in either eye (which in the opinion of the investigator may have an impact on patient safety or the integrity of data from the study eye) during the study or within 3 months prior to treatment.
- •j) Participation in any clinical study involving an investigational drug or device within 6 months prior to treatment or 5 half-lives of the drug (whichever is longer) prior to initiation of treatment
- •k) Prior stem cell administration or injections to any part of the body (subjects who have received autologous stem cell transplant will be eligible)
- •l) Use of systemic immunosuppressive agents (e.g. corticosteroid) in the 6 months prior to treatment or 5 half-lives of the drug (whichever is longer) prior to initiation of treatment (Note: inhaled, intranasal, and/or topical dermatologic steroids are allowed.)
- •m) For females, be breastfeeding or planning a pregnancy
- •n) Known hypersensitivity to any of ingredients of the excipients
研究者
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