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A Study Testing an Improved Dose of UM171 to Help Make Cord Blood Transplants More Effective and Safe.

NCT07301866 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-12-24

No results posted yet for this study

Summary

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.

Conditions

  • Acute Leukemia, High Risk
  • Myelodysplastic Syndromes, High Risk
  • Hematologic Malignancy Requiring an Allogeneic Hematopoietic Stem Cell Transplant Lacking a Donor

Interventions

BIOLOGICAL

ECT-001-CB

UM171-expanded cord blood

Sponsors & Collaborators

  • Stem Cell Network

    collaborator OTHER

  • Ciusss de L'Est de l'Île de Montréal

    lead OTHER

Principal Investigators

  • Sandra Cohen, Dr. · CIUSSS de l'Est-de-l'Ile-de-Montréal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2027-10-31
Completion
2028-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301866 on ClinicalTrials.gov