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

Phase 1

Recruiting

• Conditions: COPD; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12614000731695
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

COPD
Moderate to severe COPD (GOLD 2-3)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spirometry. Improvement in forced expratory volume in one second (FEV1) at 3, 6 months and 1 year by >50ml.<br>Improvement in 6 Minute walk test by >50m<br>The incidence of adverse events[3 months<br>6 months<br>1 year];There may be an allergic reaction to the stem cells. We will monitor the patients pulse, BP and oxygen levels. An increase in heart rate to >120, drop in BP <80 mmHg and a fall in oxygen to <90%. we will stop the infusion and give the patient antihistamines and adrenaline if required. [day 1 and week 1]

Secondary Outcome Measures

Name	Time	Method
Improvement in COPD ASSESSMENT TOOL (CAT) by >4.[3 months<br>6 months and 1 year.]