Phase I Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Rate of serious and non-serious adverse events related with the use of bone marrow mononuclear cells in patients with retinitis pigmentosa
研究概览
简要总结
The purpose of this study is to evaluate the safety of intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa by a prospective, single-center, randomized, parallel, double-blind, phase I placebo-controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retinitis Pigmentosa bilateral diagnosis.
- •Visual acuity (measured with ETDRS) less than or equal to 20/70 and visual field below 30° central in both eyes.
- •Signed informed consent
- •Warranty sufficient adherence to protocol. It must fulfill all inclusion criteria.
排除标准
- •Concurrence of any systemic or ocular disease that precludes or affects tracking study variables. Specifically retinal involvement with diabetes mellitus, glaucoma, macular degeneration or age.
- •Eye surgery in the previous 6 months.
- •Patients who are pregnant.
- •Patients with active lactation.
- •Physically fertile patients, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation excludes sexual intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS tHEY are using a reliable contraceptive method. This birth control method can be:
- •Complete abstinence from sexual intercourse
- •Surgical sterilization (tubal ligation)
- •Surgical sterilization partner (vasectomy)
- •Implanted or injectable hormonal contraceptives and oral.
- •Patients with cardiac disease, renal, hepatic, systemic, immune that might influence the survival of patients during the test.
- •Positive serology for hepatitis B, hepatitis C or HIV.
- •Clinical criteria or anesthetics that contraindicate the sedation or the extraction of BM (Altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin in the puncture site, etc.)
- •Participation in other clinical trials.
- •Inability to sign informed consent or understanding.
研究组 & 干预措施
Intravitreal injection of Autologous bone marrow Stem Cell
Patients included in the trial will receive a pars plana intravitreal injection of autologous mononuclear cells (MNC) of bone marrow (BM) in one eye (experimental group A or group). The eye in which autologous BM MNCs were injected will be determined randomly.
The average dose will be 30 million of cells (5-60 million) diluted in 0.1 ml. of saline.
干预措施: Intravitreal injection of Autologous bone marrow Stem Cell (Biological)
Subconjunctival injection of saline
Patients included in the trial will receive a subconjunctival injection of 0.1 ml of saline (SF) (placebo) in the fellow eye (group B or control group). In this way the patient will receive an injection in the control eye but avoid the risks of intraocular injection.
干预措施: Subconjunctival injection of saline (Other)
结局指标
主要结局
Rate of serious and non-serious adverse events related with the use of bone marrow mononuclear cells in patients with retinitis pigmentosa
时间窗: 12 months from baseline
次要结局
- Visual acuity (VA): Test ETDRS (Early Treatment Diabetic Retinopathy Study).(12 months from baseline)
- Study eye fundus: Made by Retinography and Angiography fluorescein.(12 months from baseline)
- Visual evoked potentials with Pattern Reversal (VEP) (altered / no altered).(12 months from baseline)
- Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25).(12 months from baseline)
- Color Vision: Ishihara Color Test.(12 months from baseline)
- Electrical retinal function: electroretinogram (ERG) (altered / unaltered).(12 months from baseline)
- Contrast sensitivity: CSV-1000E.(12 months from baseline)
- Width of retinal macula layer and nerve fiber: Measured with Optical Coherence Tomography Spectral domain (OCT)(Topcon 3D OCT-2000 Spectral Domain OCT).(12 months from baseline)
- Visual field (VF) and macular sensitivity (The Humphrey perimeter).(12 months from baseline)
- Intraocular pressure (IOP): measured in mm Hg with applanation tonometer Haag Streit AT 900.(12 months from baseline)
- Examination of the anterior and posterior pole: Made with biomicroscopy (BMC).(12 months from baseline)