A Phase I Study to Evaluate the Safety and Efficacy of Mesenchymal Stromal Cells (MSC) for Treating Chronic Obstructive Pulmonary Disease (COPD)
Royal Perth Hospital
10 participants
Jun 24, 2014
Interventional
Conditions
Summary
Hypothesis: MSCs are safe in COPD. Aims of trial ; To track MSCs post-infusion in the lung To ensure safety of MSCs We will infuse labelled MSCs and track them with nuclear imaging. We will then do a second infusion of MSCs to monitor safety
Eligibility
Inclusion Criteria2
- COPD
- Moderate to severe COPD (GOLD 2-3)
Exclusion Criteria5
- Inability to give consent
- Cardiac failure
- Renal failure
- Liver failure
- Active cancer
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
This is a safety study looking at the role of mesenchymal stem cells (MSCs) in the treatment of Chronic Pulmonary Pulmonary Disease (COPD). We will give COPD patients 2 infusions of MSCs. The first infusion will have labelled MSCs with Indium. Following the infusion, MSCs will be tracked using nuclear medicine imaging for 5 days. Thereafter, there will be a second infusion of unlabelled MSCs. Patients will be then followed up at clinics with particular assessment of symptoms, quality of life, lung function and imrpoved well being. The dose of MSC infusion (2 x 10 million/kg) per each of the two doses over 2 hours. The second dose will be at day 7. The MSCS are labelled with indium a radio-label. Therefore the stem cells will be tracked by scanning the patient and identifying the location of the stem cells on scans. There is no controls to the study.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12614000731695