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临床试验/NCT02638714
NCT02638714Unknown1 期

Treatment of Optic Neuropathies Using Autologous Bone-Marrow Derived Clusters of Differentiation (CD) 34+, 133+, and 271+ Stem Cells: A Pilot Study

Stem Cells Arabia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
1 期
入组人数
100
试验地点
2
主要终点
Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters

研究概览

简要总结

A single arm, single center trial to assess the safety and efficacy of restoring function in damaged optic nerves using autologous purified populations of bone-marrow derived stem cells (BM-SCs) through a 24 month follow up period.

详细描述

Optic nerve atrophy (ONA) is a condition defined as a damage to the optic nerve that harmfully affects central and peripheral vision. ONA may occur as a result of optic neuritis, compression by tumors or aneurysms, toxic and nutritional neuropathies, trauma, or as a secondary complication to other systemic diseases such as diabetes. Symptoms of ONA vary diversely, but mainly include blurred vision and a reduction in optic sharpness and color visualization. ONA is irreversible process, and current medical strategies focus on finding the underlying cause, and trying to prevent further vision loss and protect the other healthy eye. This is a Single arm, Single Center trial to assess the safety and efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and CD271+ stem cells through a 24 month follow-up period. The combination of these three cell types was based on their diverse potentialities to differentiate into specific functional cell types to regenerate damaged optic nerves and supporting issues and vasculature, and the availability of clinical-grade purification system (CliniMACS) and Microbeads to purify the target cell populations in clinically-approved methods. Anticipated outcomes of this study are defined in an overall improvement of vision, restoration of functions to damaged optic nerves, and improvement in quality of life of patients.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient should suffer from Optic Nerve Atrophy diseases like diabetic retinopathy and retinal pigmentation.
  • Age in between 18-55 years old
  • Willingness to undergo bone marrow derived autologous cell therapy.
  • Ability to comprehend the explained protocol
  • Ability and willingness to regularly visit to hospital for protocol and follow up

排除标准

  • Patients with preexisting or current systemic disease such as lung, liver, gastrointestinal, cardiac, immunodeficiency, syphilis, or clinically relevant polyneuropathies.
  • History of life threatening allergic or immune- mediated reaction

结局指标

主要结局

Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters

时间窗: 24 months

次要结局

  • improvement in visual function using the documentation of visual acuity using the Snellen chart(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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