An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Injected Intravitreal in Dry Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- frequency and nature of adverse events
研究概览
简要总结
This will be an open-label, non-randomized multi-center study of adipose stem cell (ASC) implantation. ASCs will be derived from the patient's adipose or fat. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via needle injection into the eye.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females between Age 50 and 90 years
- •Patients with dry AMD
- •Visual acuity in the study eye <20200 (equal to or worse than 20/200)
排除标准
- •Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- •Inability to undergo syringe liposuction procedure or have any medical problems that contraindicate the procedure.
- •Life expectancy < 6 months due to concomitant illnesses.
- •Vitrectomized eyes
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- •Active infectious disease. . If patients have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis, an expert will be consulted as to patient eligibility based on the patient's infectious status
- •Any illness which might affect a patient's survival over the follow-up period
- •Any illness which, in the Investigator's judgement, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Patients on chronic immunosuppressive transplant therapy
- •Patients with severe coagulation disorders
- •Systolic blood pressure (supine) ≤90 mmHg;
- •Resting heart rate > 100 bpm;
- •Active clinical infection being treated by antibiotics within one week of enrollment.
- •Cerebrovascular accident within 6 months prior to study entry
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •Severe COPD or severe asthma that would contraindicate surgery
- •History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last two years.
- •Unwilling and/or not able to give written informed consent.
结局指标
主要结局
frequency and nature of adverse events
时间窗: 6 months
Visual Field analysis (10-2)
时间窗: 6 months
Visual field testing can be performed clinically by keeping the subject's gaze fixed while presenting objects at various places within their visual field.
Visual Acuity Measurements
时间窗: 6 months
Visual acuity is a measure of the spatial resolution of the visual processing system. VA is tested by requiring the person whose vision is being tested to identify so-called optotypes - stylized letters, Landolt rings or other patterns - on a chart from a set viewing distance.
次要结局
- Intraocular pressure(6 months)