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临床试验/NCT04326036
NCT04326036Enrolling By Invitation早期 1 期

Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection

Black Tie Medical, Inc.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年3月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
Enrolling By Invitation
发起方
入组人数
10
试验地点
1
主要终点
Incidence of Treatment-Emergent Adverse Events

研究概览

简要总结

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes:

  • Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office.
  • January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern.
  • February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus.
  • February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19.
  • February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives..
  • March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland.
  • March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up..

March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California.

Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started.

The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied.

This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.

详细描述

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes:

  • Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office.
  • January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern.
  • February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus.
  • February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19.
  • February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives..
  • March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland.
  • March 11th, 2020 - As of this date, Over 60% of all COVID-19 deaths in the U.S. can be traced to that single nursing home in Seattle.
  • March 11th, 2020 - Dr. Fauci from the National Institutes of Health (NIH) states, "If you count all the estimated cases of people who may have it but haven't been diagnosed yet, the mortality rate is probably closer to 1%," he said, "which means it's 10 times more lethal than the seasonal flu."
  • March 21st, 2020 - The U.S. has 24,105 active cases, 301 deaths, and 171 patients declared recovered, a number which has since massively increased within the United States and Globally.
  • March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up..

March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California

Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started.

The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must have confirmed and documented Coronaviral (COVID-19) infection history with involvement of lung tissues
  • Must be clear of any viral shed residual confirmed by negative viral testing protocol accepted by the Center for Disease Control (CDC) and/or the FDA
  • Must have discharge confirmation from infectious disease managing Provider declaring freedom of viral load or active infection
  • Must have a written Medical History of Physical and discharge summary (if hospitalized) from appropriate Center or Licensed Medical Provider
  • Must agree to provide a HRCT LUNG study done at baseline (before), 3 months and 6 months
  • Must be able to provide full Informed Consent (ICF)

排除标准

  • Active or positive testing of COVID-19 With Clinical Report and Discharge Summary from Hospital or Treatment Facility
  • Lung disorder without prior confirmation by approved test protocol of history of COVID-19
  • Patient health or condition deemed dangerous or inappropriate for transport, exceeding acceptable stress for transport or care needed to achieve access to the clinical facility, at the discretion of the Providers
  • Expected lifespan of < 6 months
  • Serious of life threatening co-morbidities, that in the opinion of the investigators, may compromise the safety or compliance with the study guidelines and tracking

研究组 & 干预措施

Lipoaspiration

Experimental

Closed sterile, disposable microcannula of small volume adipose tissue, including the stromal vascular fraction (SVF) (cells and stromal tissue

干预措施: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) (Procedure)

Isolation & Concentration of cSVF

Experimental

Isolation & Concentration of cellular stromal vascular fraction (cSVF) using Healeon Centricyte 1000 Centrifuge, incubator and shaker plate with sterile Liberase enzyme (Roche Medical) per manufacturer protocols

干预措施: Centricyte 1000 (Device)

Isolation & Concentration of cSVF

Experimental

Isolation & Concentration of cellular stromal vascular fraction (cSVF) using Healeon Centricyte 1000 Centrifuge, incubator and shaker plate with sterile Liberase enzyme (Roche Medical) per manufacturer protocols

干预措施: Liberase Enzyme (Roche) (Drug)

Delivery cSVF via Intravenous

Experimental

cSVF from Arm 2 is suspended in a 250 cc of sterile Normal Saline IV solution and deployed though 150 micron in-line filtration and intravenous route over 30-60 minute timeframe

干预措施: IV Deployment Of cSVF In Sterile Normal Saline IV Solution (Procedure)

Delivery cSVF via Intravenous

Experimental

cSVF from Arm 2 is suspended in a 250 cc of sterile Normal Saline IV solution and deployed though 150 micron in-line filtration and intravenous route over 30-60 minute timeframe

干预措施: Sterile Normal Saline for Intravenous Use (Drug)

Liberase TM

Other

Use of sterile Liberase TM enzyme to allow cSVF separation and isolation

干预措施: Centricyte 1000 (Device)

Liberase TM

Other

Use of sterile Liberase TM enzyme to allow cSVF separation and isolation

干预措施: Liberase Enzyme (Roche) (Drug)

Sterile Normal Saline

Other

250 cc of sterile Normal Saline for Intravenous with sterile 150 micron in-line filtration for suspension of the concentrated cSVF and deployment IV

干预措施: IV Deployment Of cSVF In Sterile Normal Saline IV Solution (Procedure)

Sterile Normal Saline

Other

250 cc of sterile Normal Saline for Intravenous with sterile 150 micron in-line filtration for suspension of the concentrated cSVF and deployment IV

干预措施: Sterile Normal Saline for Intravenous Use (Drug)

结局指标

主要结局

Incidence of Treatment-Emergent Adverse Events

时间窗: 1 month

Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0

次要结局

  • Pulmonary Function Analysis(baseline, 3 Month, 6 months)
  • Digital Oximetry(3 months, 6 months)

研究者

发起方
Black Tie Medical, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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