None listed
Conditions
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.
Interventions
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
Sponsors
Mater Medical Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 40 Years
Healthy volunteers
No
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.
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
Outcome results
None listed