NCT01808378Unknown2 期
Phase IIa Clinical Trial to Study the Feasability and Security of the Expanded Autologous Stem Cells (ASC) From Lipoaspirate in the Bilateral Limbic Associated Keratopathy Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy
研究概览
简要总结
Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated keratopathy
详细描述
Intralesional use by inject of adipose derived stem cells
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
- •Signed informed consent
- •Previously diagnosed bilateral limbic obstruction
- •Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
- •Suffering chronic keratopathy accomplishing the following criteria:
- •Confirmed limbic obstruction with an impression cytology
- •Repeated usual treatment failure for this pathology
排除标准
- •Having suffered a neoplasia in the previous 5 years
- •Local anesthesia allergies
- •Patients having participate in any other study in the previous 90 days to the inclusion
- •Patients on medication with tacrolimus or cyclosporine in the 4 previous week to the cellular therapy
- •Any medical or psychiatric illness that, in the investigator opinion, could suppose a reason for the study exclusion
- •Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
- •Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
- •Patients who have suffering major surgery or severe trauma in the prior 6 months
- •Pregnant or breastfeeding women
研究组 & 干预措施
Autologous Stem Cells
Experimental
Autologous expanded adipose-derived stem cells
干预措施: Expanded adipose-derived stem cells (Drug)
结局指标
主要结局
Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy
时间窗: 16 weeks
Micro ocular Photography Visual acuity
次要结局
- Adverse events(1, 4, 16, 24 weeks)
- Quality of life assessment using the SF-12 Questionnaire(1, 4, 16, 24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)Extremely Complex Perianal FistulaeNCT01586715Instituto de Investigación Hospital Universitario La Paz10
已完成
2 期
Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic KeratosisActinic KeratosisNCT03538951Vidac Pharma83
Unknown
2 期
G-CSF and Autologous Cord Blood Infusion in Cerebral PalsyCerebral PalsyNCT02866331Hanyang University Seoul Hospital88
Unknown
1 期
Treatment of Optic Neuropathies Using Autologous Bone Marrow-Derived Stem CellsOptic NeuropathyNCT02638714Stem Cells Arabia100
已完成
2 期
Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO)Urinary IncontinenceNCT01799694Instituto de Investigación Hospital Universitario La Paz10