TerminatedPhase 1ACTRN12607000279426

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

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


Sponsor

Mater Medical Research Institute

Enrollment

9 participants

Start Date

May 9, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 0 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase I study tests the safety of infusing placenta-derived stem cells (mesenchymal stem cells) alongside umbilical cord blood transplant in patients with blood disorders. It is for patients from birth to age 40 who have a suitable unrelated donor cord blood graft available. Participants receive the stem cell infusion during their transplant and are closely monitored for safety and signs of graft acceptance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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/

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


Locations(1)

NSW, Australia

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ACTRN12607000279426