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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
Executive Officer
University of Tasmania (UTAS), Research and Development Office
GPO Box 252-01
Hobart
Tasmania 7001
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
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 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.
We are aiming to study 30-50 patients with different haematological malignancies that require stem cell harvest with subsequent stem cell transplantation during a period of 24 months at the LGH, Tasmania. Current numbers of autologous stem cell harvest at a single centre; the LGH are varied between 20 and 30 episodes per year. Our current autologous stem cell harvest-protocol for patients with malignant haematological disorders is employing mobilisation chemotherapy with cyclophosphamide 5g/m2 and subsequent administration of granulocyte colony stimulating factor (G-CSF) subcutaneously daily at a dose of 10mcg/kg body weight (BW) until harvesting sufficient stem cells per transplant defined as at least 2x106 stem cells/Kg BW.
We will start to measure both CD 34+ and CD 133+ daily using the flow cytometr (Becton-Dickenson) when the white cell count (WCC) recovers above 1.0/nL post chemotherapy and until the time of stem cell harvest at the Holman Clinic. Thereafter we will measure both markers according to manufacturer reccomendations
(with commercially available CD34 and CD133 kits) in the harvest product for each patient. Correlation between the amount of harvested CD 34+/CD133+ cells and patient engraftment will be documented for each patient. Using commercially available kits, we are proposing to study the progenitors cells which express
CD133 antigen by flow cytometry technique according to the manufacturer recommendations as a part of the usual daily measurement of CD34+ cells. There is no additional sample will be required from patients and hence this will not expose the participants to any extra burden. Also we are proposing to measure CD133+ in addition to CD34+ stem cells in the stem cell product garnered by the stem cell harvest. Using flow cytometry to study stem cell characteristics in the leukaphoresis product will provide useful information regarding engraftment kinetics. Platelets engraftment is defined as reaching platelet count>20/nL without substitution, while neutrophil engraftment is defined as reaching neutrophil count above>0.5/nL.
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
khalafallah@dhhs.tas.gov.au
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
khalafallah@dhhs.tas.gov.au

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