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A Phase I Study to Evaluate the Safety and Efficacy of Mesenchymal Stromal Cells (MSC) for Treating Chronic Obstructive Pulmonary Disease (COPD)

A Phase I Study to Evaluate the Safety and Efficacy of Mesenchymal Stromal Cells (MSC) for Treating Chronic Obstructive Pulmonary Disease (COPD)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000731695
Enrollment
10
Registered
2014-07-10
Start date
2014-06-24
Completion date
2014-12-24
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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, lu

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.

Sponsors

Royal Perth Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
60 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

COPD Moderate to severe COPD (GOLD 2-3)

Exclusion criteria

Inability to give consent Cardiac failure Renal failure Liver failure Active cancer

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026