Effectiveness and Safety of Subtenon Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Glaucomatous Neurodegeneration
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- SAEs and SARs monitoring
研究概览
简要总结
Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. ADRC will be administered one-time into subtenon space of patient's eyeball. This is a single arm study with no control. All patients receive cell therapy.
详细描述
Fat tissue obtainment:
Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.
ADRC isolation:
Aspirated fat tissue placed into sterile vessel which inserted into Celution 800/CRS System (Cytori Therapeutics Inc) - closed system for automated and standardized extraction and concentration of ADRC. Celution 800/CRS System drains excess of fluid from fat tissue and estimate it's volume After that lipoaspirate washed extensively with equal volumes of Ringer's solution to remove blood. At the end of this process System indicates required volume of enzyme reagent (Celase®) which should be added immediately by operator. After enzyme treatment Celution 800/CRS System automatically transfers isolated ADRC into washing compartment where ADRC washed and concentrated in 5 mL suspension. Tissue processing time - approximately 60 minutes. ADRC suspension match all requirements listed in technical documentation for Celution 800/CRS System. Obtained ADRC divided into 2 portions. First portion (0.2-0.5 mL) used for counting, viability and sterility assessment. Second portion placed into sterile syringe for injection.
Subtenon injection of ADRC:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffers from primary open-angle glaucoma (II and III stages; singe eye or both eyes) at least for 6 months
- •Intraocular pressure is stable for at least for 3 months
- •Visual acuity of each eye (measured by using visual acuity charts projector) not less than 0,1
- •Patient is familiar with Participant information sheet
- •Patient signed informed consent form
- •Non-inclusion Criteria:
- •Contraindications to the local anesthesia or medical history of allergic reactions to local anesthetics
- •Any anomalies or conditions of at least one eye which can limit tonometry implementation
- •Inflammatory disease of at least one eye or auxiliary apparatus (both infectious and non-infectious etiology: conjunctivitis, keratitis, uveitis, dacryocystitis etc.)
- •Medical history of surgery on at least one eye during preceding 6 months.
- •Medical history of heavy traumatic injury of eyes
- •Patient has a cataract with high degree of lens opacification which can limit planned eye examination
- •Patient prescribed for systemic corticosteroids or other medications treatment with proven effect leading on intraocular pressure increase
- •Medical history or present dry eye syndrome accompanied by corneal and conjunctival xerosis
- •Subcompensated or decompensated forms of chronic diseases of internal organs
- •Clinically significant abnormalities in results of laboratory tests
- •Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
- •Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
- •Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
- •Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
- •Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior lipoaspiration
- •Medical history of heterotopic ossifications
- •Patients prescribed for glycoprotein inhibitors treatment
- •Acute vascular pathology
- •Age-related macular degeneration
排除标准
- •Patient's refusal from the further participation in trial
- •Patient's refusal from compliance with the requirements of contraception during the participation in research
- •Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockroft-Gault formula)
- •Confirmed syphilis, HIV, hepatitis B or C infections
- •Dropout Criteria:
- •Direct indications on immediate initiation of treatment with medications with proven effect leading to intraocular pressure increase
- •Pregnancy
- •Development of cataract with high degree of lens opacification which can limit planned eye examination
研究组 & 干预措施
ADRC injection
Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected into subtenon space of patient's eye.
干预措施: Liposuction (Procedure)
ADRC injection
Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected into subtenon space of patient's eye.
干预措施: Subtenon administration of autologous ADRC (Other)
ADRC injection
Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected into subtenon space of patient's eye.
干预措施: ADRC isolation (Device)
结局指标
主要结局
SAEs and SARs monitoring
时间窗: 4 weeks after treatment
Types, probability and severity of treatment emergent serious adverse events (SAEs) and serious adverse reactions (SARs)
次要结局
- Change in visual acuty(Follow up to completion (up to 48 weeks after treatment))
- Change in visual field(Follow up to completion (up to 48 weeks after treatment))
- Change in intraocular pressure(Follow up to completion (up to 48 weeks after treatment))
- Quality of life monitoring(Follow up to completion (up to 48 weeks after treatment))
- Changes in structures of fundus of the eye-2(Follow up to completion (up to 48 weeks after treatment))
- Changes in structures of fundus of the eye-1(Follow up to completion (up to 48 weeks after treatment))
- Change in retinal flicker responce(Follow up to completion (up to 48 weeks after treatment))