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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
082008
ACTR Number:
ACTRN12607000279426
Trial Status:
Registered
Date Submitted:
9/05/2007
Date Registered:
25/05/2007
Page 1
Public title:
A phase I multicentre open label dose-escalation study of unrelated, Major Histocompatibility (MHC)-unmatched placenta-derived mesenchymal stem cells (MSC) in recipients of unrelated umbilical cord blood haematopoietic stem cell (HSC) transplants.
MMRI CT4-MSC-UCB-001 Mater 954A
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ANZCTR registration title:
A phase I multicentre open label dose-escalation study to investigate the safety and feasibility of escalating doses of unrelated, Major Histocompatibility (MHC)-unmatched placenta-derived mesenchymal stem cells (MSC) in recipients of unrelated umbilical cord blood haematopoietic stem cell (HSC) transplants.
MMRI CT4-MSC-UCB-001 Mater 954A
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Secondary ID:
UTN:
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Trial acronym:
MMRI CT4 MSC UCB 001
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Page 2
Health condition(s) or problem(s) studied:
Patients undergoing unrelated unmatched umbilical cord blood stem cell transplants
Condition category:
Condition code:
Cancer
Children's - Leukaemia & Lymphoma
Cancer
Leukaemia - Acute leukaemia
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer
Myeloma
Page 3
Description of intervention(s) / exposure:
There are 3 groups of patients. In each group there are 3 patients. All umbilical cord blood recipients (patients) will receive only one dose of MSCs intravenously Group 1 will receive 1 x 10E6 MSC/kg Group 2 will receive 3.3 x 10E6 MSC/kg Group 3 will receive 10 x 10E6 MSC/kg
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Intervention code:
Treatment: drugs
Comparator / control treatment:
No comparator group
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Control group:
Dose comparison
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Page 4
Primary outcome 1:
Infusional toxicity
Timepoint:
15minutes, 30minutes, 1 hour, 2 hours and 4 hours post infusion of MSCs
Primary outcome 2:
Adverse events including infections and recurrence of the underlying malignancy
Timepoint:
Day 1 through to Day 27 on a daily basis, Day 28, Day 42 (+/- 3 days), Day 100 (+/-14 days) 12 months (+/0 14 days) and 24 months (+/-14 days)
Primary outcome 3:
Formation of Ectopic Tissue Foci.
Timepoint:
Day 100, 12 and 24 months ( +/- 14 days)
Primary outcome 4:
Determination Of relapse
Timepoint:
On recurrence of original malignant disease after transplantation
Primary outcome 5:
Human Mesenchymal Stem Cells and Umbilical Cord Blood Chimersim in Bone Marrow:
Timepoint:
Once during days 21-28, and on days 42,100 and 1 year
Secondary outcome 1:
Engraftment of platelets
Timepoint:
Is defined as the day post transplant which is the first of 3 consecutive measurements when the platelet count is equal to, or greater than, 20 x 109/ul without transfusion support in the previous 7 days.
Secondary outcome 2:
Engraftment of neutrophils
Timepoint:
Is defined as the day post transplant which is the first of 3 consecutive measurements when the neutrophil count is equal to, or greater than, 0.5 x 109/ul.
Secondary outcome 3:
Incidence and severity of acute Graft Versus Host Disease
Timepoint:
Day 28, day 42 and day 100 post transplantation.
Page 5
Key inclusion criteria:
Patient is willing and has a 4/6, 5/6 or 6/6 Human Leucocyte Antigen matched unrelated donor Umbilical Cord blood graft with a cell dose >2.0 x 107 nucleated cells/kg recipient actual body weight.Patient or guardian must furnish written informed consent. Patients must have a life-threatening disease requiring treatment by unrelated cord blood transplantation Adequate cardiac function with a left ventricular ejection fraction > 45% of predicted.Adequate pulmonary function as defined as no severe or symptomatic restrictive or obstructive lung disease, and pulmonary function testing showing an Forced Expiratory Volume in 1 second >50% of predicted and a Diffuse Lung capacity for Carbon monoxide >50% of predicted. (Children less than 6 years of age must have normal oxygen saturation, in the opinion of the Investigator)Adequate renal function as defined by a creatinine clearance >40% of normal.Adequate hepatic function as defined by a total bilirubin < 2x normal or absence of hepatic fibrosis/cirrhosis.Adequate neurologic function as defined by no evidence of a severe central or peripheral neurological abnormality. Adequate immunologic function as defined by no evidence of active infection at the time of the transplant preparative regimen.Female patients are not pregnant, not breast-feeding and are using adequate birth control techniquePatient must be Human Immunodeficiency Virus (HIV)-1 & 2 antibody, Human Immunodeficiency Virus (HIV)-1 antigen, and Human lymphotropic Virus (HTLV) I & II antibody sero-negative Patient has an Eastern Cooperative Group (ECOG) performance status of 0, 1, or a Karnofsky/ Lansky score of 70.(Use Lansky Play Scale for patients less than 16 y.o.)Patient must demonstrate ability to be compliant with medical regimen.
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Minimum Age:
0
Years
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Maximum Age:
40
Years
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Gender:
Both males and females
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Healthy volunteers?
No
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Key exclusion criteria:
Patient has a consenting Human Luekocyte Antigens (HLA)-A-B-DRB1 identical or 5/6 HLA antigen matched related hematopoietic stem cell donor.Patient does not have a minimum Umbilical Cord Blood dose of at least 2.0 x 107 total nucleated cells/kg actual body weight (based on cryopreserved cell count of umbilical cord blood product) available from the unrelated Umbilical Cord Blood donor who is a 4/6, 5/6, or 6/6 HLA-matched.Patient has an active infection at time of transplantation.Patient has active alcohol or substance abuse within 6 months of study entry.Patient is enrolled on another investigational agent concurrently.Patient has any medical condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient.Patient has had a prior hematopoietic stem cell transplant or solid organ transplant
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Page 6
Study type:
Interventional
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Purpose of the study:
Treatment
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Allocation to intervention:
Nonrandomised trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
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Masking / blinding:
Open (masking not used)
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Assignment:
Single group
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Other design features (specify):
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Type of endpoint(s):
Safety
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Page 7
Phase
Phase 1
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Anticipated or actual date of first participant enrolement:
9/05/2007
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Target sample size:
9
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Recruitment status:
Open to recruitment
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Page 8
Funding source:
Charities/Societies/Foundations
Name:
Inner Wheel of Australia
Address:
Val Corva 38-42 Parkes St McCray Vic 3938
Country:
Australia
Primary sponsor:
Individual
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Reason:
Name:
Mater Medical Research Institute
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Address:
Level 3 Aubigny Place Raymond Terrace South Brisbane Queensland 4101
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Country:
Australia
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Secondary sponsor:
Hospital
Name:
Mater Health Services
Address:
Raymond Terrace South Brisbane Q 4101
Country:
Australia
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name 1:
Mater Health Services (incorporating Mater Medical Research Institute and Mater Mother's Hospital
Address:
Raymond Terrace South Brisbane Q 4101
Country:
Australia
Date of approval:
23/02/2007
HREC Number:
954A
Ethics Committee name 2:
Westmead Hospital
Address:
Cnr Hawkesbury and Darcy Roads Westmead NSW 2145
Country:
Australia
Date of approval:
25/10/2006
HREC Number:
2006/7/4.8(2386)
Ethics Committee name 3:
Sydney Children's Hospital
Address:
Hight Street Randwick NSW 2031
Country:
Australia
Date of approval:
24/04/2007
HREC Number:
07/016
Countries of recruitment:
Australia
Postcode:
2031, 2145
Brief summary:
Phase 1
This trial investigates the safety and feasibility of escalating doses of mesenchymal stem cells (multipotent stem cells that can differentiate into a variety of cell types) in people with life-threatening disease requiring umbilical cord blood transfusion.
Who is it for?
You can join this study if you have a life threatening disease – either leukaemia, lymphoma or myeloma – requiring umbilical cord blood transfusion. There are only nine participants in this trial.
Trial details
Participants will receive an infusion of mesenchymal stem cells. There will be three groups of three people only, given different doses of mesenchymal stem cells. Infusion toxicity will be measured up to 4 hours after transfusion. Adverse events including infection and recurrence of cancer up to 2 years after transfusion will also be measured. This trial aims to test the safety and feasibility of treatment with mesenchymal stem cells.
The study will test the safety and feasibility of manufacturing mesenchymal stem cells from the placentas of women undergoing elective Caesarean section and transplanting the cells into people with life threatening blood cancers. The placentas would otherwise be discarded.
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Trial website:
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Presentations / publication list:
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Page 10
Contact person for public queries
Name:
Sonia Hancock
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Address:
Mater Medical Research Institute Level 3 Aubigny Place Raymond Terrace South Brisbane QLD 4101
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Country:
Australia
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Tel:
+61 7 38401558
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Fax:
+61 7 38402134
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Email:
shancock@mmri.mater.org.au
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Contact person for scientific queries
Name:
Professor Kerry Atkinson
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Address:
Division of Cancer Services Mater Health Services Level 3 MAH Raymond Terrace South Brisbane QLD 4101
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Country:
Australia
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Tel:
+61 7 3163 3429
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Fax:
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Email:
kerry.atkinson@mater.org.au
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Contact person responsible for updating information
Name:
Sonia Hancock
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Reason:
Address:
Level 3 Aubigny Place Raymond Terrace South Brisbane Q 4101
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Country:
Australia
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Tel:
07 3163 2564
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Fax:
07 3163 2550
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Email:
shancock@mmri.mater.org.au
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