Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000590268
Ethics application status
Approved
Date submitted
13/07/2009
Date registered
16/07/2009
Date last updated
16/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of the role of CD133+ as a cell marker for human haematopoietic stem cells
Scientific title
A pilot study of the role of CD133+ as a cell marker for human haematopoietic stem cells for patients undergoing autologous stem cell tranplantation
Universal Trial Number (UTN)
Trial acronym
CD 133
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stem cell transplantation 236920 0
Condition category
Condition code
Blood 237278 237278 0 0
Haematological diseases
Cancer 239552 239552 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic transplantation of haematopoietic stem cells (HSCs) is an increasing area of interest in
medicine. In autologous stem cell transplantation, there is the ability to harvest stem cells soon after
chemotherapeutic treatment, and then cryo-preserve and store such cells for stem cell transplantation at a later date.
CD34 is the typical cell marker used to identify HSCs for transplantation. There exist certain limitations to CD34+ HSCs which include its expression on cells not capable engraftment, and also on acute leukaemic cells. CD133 is an alternative cell surface marker on HSCs which could prove useful in identifying cells for
transplantation. Preliminary research suggests that CD133 is a more primitive marker, which is expressed
by early progenitor cell line, and it has the additional advantage of not being expressed on acute leukaemic
cells.
The Launceston General Hospital is the site for stem cell harvest for the North and North-West of Tasmania.
Annually, approximately 20-30 patients undergo stem cell harvest typically one time over few days (majority of patients can successfully harvest over 1-2 days), which usually lasts few hours on each harvest day depending on the amount of cell harvested with the aim of later transplantation. This project is a pilot study to evaluate the value of CD133 in addition to the usual marker CD34+ as a cell marker for HSCs while using the current protocol for stem cell harvest. There is currently little data on the validity of
CD133 as a HSC marker, and this project, as a part of Master degree at the School of Human Life Sciences at the University of Tasmania, aims to add to the current data and potentially identify the role of CD133 as HSC marker.
Intervention code [1] 236707 0
Diagnosis / Prognosis
Intervention code [2] 236925 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238087 0
To measure stem cells that express CD 133 vial flow cytometry technique.
Timepoint [1] 238087 0
By completion of stem cell harvest
Secondary outcome [1] 242286 0
To correlate the amount of stem cell harvested with the engraftment kinetics after stem cell transplanatation assessed by regular full blood count daily after transplantation.
Timepoint [1] 242286 0
Haematological recovery after autologous stem cell transplantation, which is typically range between 2-3 weeks after transplantation.

Eligibility
Key inclusion criteria
Patients requiring stem cell harvest at the Launceston General Hospital with subsequent stem cell transplantation .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 years of age. People with intellectual or mental impairment.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237097 0
Hospital
Name [1] 237097 0
Launceston General Hospital, Pathology Department
Country [1] 237097 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital, Pathology Department
Address
charles St
Launceston
Tasmania, 7250
Country
Australia
Secondary sponsor category [1] 236824 0
None
Name [1] 236824 0
Address [1] 236824 0
Country [1] 236824 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239196 0
Tasmania Health and Medical Human Research Ethics Committee EC00337
Ethics committee address [1] 239196 0
Ethics committee country [1] 239196 0
Australia
Date submitted for ethics approval [1] 239196 0
Approval date [1] 239196 0
04/03/2008
Ethics approval number [1] 239196 0
H0009780

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29698 0
Address 29698 0
Country 29698 0
Phone 29698 0
Fax 29698 0
Email 29698 0
Contact person for public queries
Name 12945 0
Assoc Prof Alhossain Khalafallah
Address 12945 0
Launceston General Hospital
Charles St
Launceston,
Tasmania 7250
Country 12945 0
Australia
Phone 12945 0
+613 6348 7111
Fax 12945 0
Email 12945 0
[email protected]
Contact person for scientific queries
Name 3873 0
Assoc Prof Alhossain Khalafallah
Address 3873 0
Launceston General Hospital
Charles St
Launceston,
Tasmania 7250
Country 3873 0
Australia
Phone 3873 0
+613 6348 7111
Fax 3873 0
Email 3873 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.