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临床试验/NCT05562843
NCT05562843已完成不适用

Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004

H-CYTE1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Pulmonary Lung Function

研究概览

简要总结

For this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using proprietary Emcyte™ equipment/centrifugation, and then returned to the patient same day via the peripheral circulation. As circulation occurs, the concentrated cells enter the right heart and are then disseminated into the lungs, becoming trapped in the lung's microcirculation. Here, the cells are believed to produce multiple bioactive factors such as cytokines and anti-inflammatory mediators. Several growth factors are released by activated platelets becoming honing cells for healing within the tissue. The exact long-term mechanism of action of PRP-PC in the lungs remains under investigation. Safety studies have proven that autologous treatment is incredibly safe, largely because of the minimal cell manipulation and the autologous nature of the cells. Prior observational studies in this are have shown strong safety profiles as well as strong efficacy in both COPD and ILD.

详细描述

Study Objective(s) Primary

  • To determine if pulmonary function improves following ceullar therapy Secondary
  • To determine if participants' perceived quality of life related to breathing improves following cellular therapy To evaluate the safety of autologous PRP-PC administration for chronic lung disease

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects age 18 and older
  • Diagnosis of COPD or an interstitial lung disease

排除标准

  • Pregnant subjects, subjects with an active cancer diagnosis except for basal cell skin cancer-

结局指标

主要结局

Pulmonary Lung Function

时间窗: 3 months

Lung function will be measured with spirometry to test FVC volume, FVC % predicted, FEV1 volume, and FEV1% predicted.

次要结局

  • Quality of Life subjective(3 and 12 months)

研究者

发起方
H-CYTE
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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