This clinical study is testing a new way to improve stem cell transplants for adults with high-risk blood cancers, such as leukemia or myelodysplasia, who do not have a suitable donor. The transplant uses stem cells from umbilical cord blood that have been expanded in the lab using a molecule called UM171. Previous studies showed that UM171 helps these cells grow and work better, leading to faster blood count recovery and fewer complications.
In this study, researchers are testing whether increasing the dose of UM171 during the lab expansion process can make the transplant less toxic. The hypothesis is that using a higher dose of UM171 to expand cord blood stem cells will help patients recover blood counts faster after transplant by improving the growth and function of the cells. This may lead to better immune recovery, fewer infections, shorter hospital stays, and improved overall outcomes.
Only seven patients will be enrolled, and they will be followed for one year after their transplant.
Subjects ≥ 18 and ≤ 67 years old,
Patient with either i. High risk acute leukemia or myelodysplasia defined as expected 2 year OS or PFS < 40% after a conventional allogeneic HSC transplant or ii. A hematologic malignancy requiring an allogeneic hematopoietic stem cell transplant and lack of a suitable HLA identical, haploidentical or 7/8 HLA matched donor.
A back up graft must have been identified prior to initiation of conditioning regimen.
Signed written informed consent.
Allogeneic or autologous myeloablative transplant within last 6 months.
Positive anti-donor HLA antibodies with MFI above 1500 against the selected CB (PI may approve an MFI up to 5000; if above 2500, desensitization is strongly recommended)
Use of an investigational agent within 30 days (defined as a drug not approved by Health Canada or FDA regardless of indication) of start of chemotherapy unless documented approval obtained from Sponsor.
Presence of ≥30% blasts in bone marrow or ≥ 0.5 x109/L blasts in circulating blood
Ciusss de L'Est de l'Île de Montréal
Lead sponsor
Stem Cell Network
Collaborator