Use of Autologous Stem/Stromal Cells In Chronic Lung Disorders: Obstructive (COPD) & Restrictive (RLD)
Paused · Phase 1
Conditions studied: COPD, Respiratory Insufficiency
In brief
Pulmonary Disorders are often categorized as Obstructive or Restrictive disorders. This study will establish two channels of investigation, one group within each type of pulmonary dysfunction. State-of-the-Art Objective analytics will be employed to track patients from baseline and 6 month intervals for up to one year. 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. COPD is generally considered those who are able to better inspire air than to expel. Restrictive lung dysfunctions are generally considered those who are unable to achieve full inspiration function. Both can create some of the same symptoms, low Oxygen exchange, activity intolerance of exertion, shortness of breath (SOB), Pulmonary Hypertension, Loss of lung structure, Pneumothorax (in emphysema), may mandate supplemental Oxygen therapy, failure of airway mucus management (chronic bronchitis, bronchiectasis, etc), and other failure of lung function issues. Restrictive lung disorders represent a group of pulmonary function losses which are due to acquired fibrosis, congenital fibrotic disorders, functional airway damage (scarring), vascular abnormalities in arterial/venous supply, Air pollution and tobacco smoking, chemical inhalation damage, etc. are felt to be common contributor of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with anti-asthma bronchodilators, steroids, and a variety of combination of topical medications. Study is an interventional study to document the safety and efficacy of use of cSVF in chronic broncho-pulmonary disease within both groups.
Key facts
- Study ID
- NCT03909750
- Run by
- Healeon Medical Inc
- People needed
- 50
- Starts
- 2019-04-10
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2024-10-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented COPD or RLD by qualified Medical Provider
- History of Pulmonary Function Deficits or supplemental oxygen therapy
You may not qualify if…
- Cancer of the Lung
- Patient's on chemotherapy or radiation for Cancer (or History within 5 years)
- Inability to comply with Baseline and 6 month post-treatment HDCT lungs
- General health or inability or unwillingness or ability to provide informed consent for study
- History of lung transplantation
- Life expectancy of <3 months due to concomitant illnesses
- Exposure to any investigational drug of procedure within 1 month prior to study enrollment which may interfere with interpretation of outcomes
- Illness which, in investigator's judgement, may interfere with patient's ability of comply with protocol, compromise patient safety, ability to provide informed consent or interfere with the interpretation of study outcomes.
- Subjects with chronic immunosuppressive or chemotherapeutic medication.
- Known drug or alcohol dependence or other factors which may interfere with study conduct or interpretation of result in opinion of investigators.
- Subjects with documented Alpha 2 Antitrypsin Deficiency (inherited lung and liver disorder)
- Patient with history of Hepatitis (except Hepatitis A history)
Where it is running
- Global Alliance for Regenerative Medicine-USA — Stevensville, Montana, United States
- Global Alliance of Regenerative Medicine (GARM) International — Roatán, Hn, Honduras
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.