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Trial registered on ANZCTR


Registration number
ACTRN12614000731695
Ethics application status
Approved
Date submitted
27/06/2014
Date registered
10/07/2014
Date last updated
10/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I Study to Evaluate the Safety and Efficacy of Mesenchymal Stromal Cells (MSC) for Treating Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A Phase I Study to Evaluate the Safety and Efficacy of Mesenchymal Stromal Cells (MSC) for Treating Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 284876 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 292312 0
Condition category
Condition code
Respiratory 292649 292649 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289684 0
Treatment: Other
Comparator / control treatment
No control. Treatment arm only.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292487 0
Spirometry. Improvement in forced expratory volume in one second (FEV1) at 3, 6 months and 1 year by >50ml.
Improvement in 6 Minute walk test by >50m
The incidence of adverse events
Timepoint [1] 292487 0
3 months
6 months
1 year
Primary outcome [2] 292488 0
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.
Timepoint [2] 292488 0
day 1 and week 1
Secondary outcome [1] 309090 0
Improvement in COPD ASSESSMENT TOOL (CAT) by >4.
Timepoint [1] 309090 0
3 months
6 months and 1 year.

Eligibility
Key inclusion criteria
COPD
Moderate to severe COPD (GOLD 2-3)
Minimum age
60 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give consent
Cardiac failure
Renal failure
Liver failure
Active cancer


Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient suitability is deteremined by Dr Yuben Moodley - Principal Investigator. The patients who fulfill the inclusion and exclsuion criteria will then be given patient information and the offer to participate in the study. If they agree, consent is signed and the patient recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis
This is a safety trial and there was no specific statistical methods used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2681 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 8365 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 289496 0
Hospital
Name [1] 289496 0
Royal Perth Hospital
Address [1] 289496 0
50 Murray Street
Perth
6000
Western Australia
Country [1] 289496 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
50 Murray Street
Perth
6000
Western Australia
Country
Australia
Secondary sponsor category [1] 288179 0
None
Name [1] 288179 0
Address [1] 288179 0
Country [1] 288179 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291249 0
Royal Perth Human Ethics committee
Ethics committee address [1] 291249 0
Colonial House
Murray Street
Perth
6000
Western Australia
Ethics committee country [1] 291249 0
Australia
Date submitted for ethics approval [1] 291249 0
25/10/2012
Approval date [1] 291249 0
19/02/2013
Ethics approval number [1] 291249 0
2012/103

Summary
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
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 49498 0
A/Prof Yuben Moodley
Address 49498 0
School of Medicine and Pharmacology
University of Western Australia
50 Murray Street
Perth
6000
Western Australia
Country 49498 0
Australia
Phone 49498 0
+61 8 92240232
Fax 49498 0
+61 8 92240246
Email 49498 0
yuben.moodley@uwa.edu.au
Contact person for public queries
Name 49499 0
A/Prof Yuben Moodley
Address 49499 0
School of Medicine and Pharmacology
University of Western Australia
50 Murray Street
Perth
6000
Western Australia
Country 49499 0
Australia
Phone 49499 0
+61 8 92240232
Fax 49499 0
+61 8 92240246
Email 49499 0
yuben.moodley@uwa.edu.au
Contact person for scientific queries
Name 49500 0
A/Prof Yuben Moodley
Address 49500 0
School of Medicine and Pharmacology
University of Western Australia
50 Murray Street
Perth
6000
Western Australia
Country 49500 0
Australia
Phone 49500 0
+61 8 92240232
Fax 49500 0
+61 8 92240246
Email 49500 0
yuben.moodley@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
No Results