Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-02 @ 10:02 AM
Study NCT ID:
NCT02946658
Status:
SUSPENDED
Last Update Posted:
2025-09-12
First Post:
2016-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders
Sponsor:
Healeon Medical Inc
Organization:
Study Overview
Official Title:
Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders
Status:
SUSPENDED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19 stopped patient ability to complete access for outcome analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADcSVF-COPD
Brief Summary:
Chronic Obstructive Pulmonary Disease (COPD) is a lung-related disorder that is characterized by long-term, often progressive state of poor airflow. Primary symptoms include low oxygen tension, shortness of breath, productive cough, and broncho-pulmonary inflammation and interference with oxygen-carbon dioxide exchange.
Air pollution and tobacco smoking are felt to be the most common cause of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with antiasthma bronchodilators.
Study is an interventional study to document the safety and efficacy of use of AD-cSVF in chronic broncho-pulmonary disease groups.
Air pollution and tobacco smoking are felt to be the most common cause of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with antiasthma bronchodilators.
Study is an interventional study to document the safety and efficacy of use of AD-cSVF in chronic broncho-pulmonary disease groups.
Detailed Description:
COPD is often treated by limiting exposure to poor air quality, but there is no cure at this time. Attempted therapy include smoking cessation, vaccinations, respiratory rehabilitation, and attempts of use of bronchodilators and steroids. Many resort to supplemental oxygen therapy, lung transplantation, and antibiotic supportive therapy during exacerbations.
As of 2013, COPD involve approximately 5% pf the global populations (approximately 330 million). Most commonly it occurs approximately equally between men/women and result in about 3 million deaths per year. Estimates of economic costs are estimated to be more than 2.1 trillion dollars in 2010.
This study includes microcannula harvesting of subdermal adipose tissues, incubation, digestion and isolation of AD-cSVF. This stromal cellular pellet (without actual extracellular matrix or stromal elements) is then suspended in 500 cc sterile Normal Saline (NS) and deployed via peripheral intravenous route. Evaluations of safety issues are measured at intervals (both severe and non-severe categories) and by repeated pulmonary function studies.
As of 2013, COPD involve approximately 5% pf the global populations (approximately 330 million). Most commonly it occurs approximately equally between men/women and result in about 3 million deaths per year. Estimates of economic costs are estimated to be more than 2.1 trillion dollars in 2010.
This study includes microcannula harvesting of subdermal adipose tissues, incubation, digestion and isolation of AD-cSVF. This stromal cellular pellet (without actual extracellular matrix or stromal elements) is then suspended in 500 cc sterile Normal Saline (NS) and deployed via peripheral intravenous route. Evaluations of safety issues are measured at intervals (both severe and non-severe categories) and by repeated pulmonary function studies.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: