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Stem Cell Transplantation

Cord Blood Transplant for Blood Cancers

Phase 2
Waitlist Available
Led By Sandra Cohen, MD
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute Myeloid Leukemia:
- Must come from a cord bank that is FACT (Foundation for the Accreditation of Cellular Therapy) accredited, FDA approved or eligible for NMDP IND.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new way to expand cord blood cells so that they can be used in a stem cell transplant. This is important because cord blood transplants are associated with a lower risk of relapse, especially in the presence of minimal residual disease, and a low risk of chronic graft versus host disease. However, cord blood transplants are hampered by a higher risk of transplant related mortality when compared to bone marrow/peripheral blood transplants because of the limited cell dose of cord blood. The UM171 expansion protocol has proven to be technically feasible and safe in a previous trial and is associated with a low risk of transplant related mortality and graft versus

Who is the study for?
This trial is for adults aged 18-70 with high-risk acute leukemia or myelodysplasia, who have had inadequate responses to previous treatments or relapsed after transplants. Participants must meet specific health criteria including organ function and a Karnofsky score of at least 70%, indicating they are able to care for themselves.Check my eligibility
What is being tested?
The study tests the effectiveness of transplanting cord blood that has been expanded using ECT-001 technology in patients with aggressive blood cancers. It aims to see if this method can improve survival rates by providing better matched, higher quality stem cells than traditional methods.See study design
What are the potential side effects?
Potential side effects may include complications from the transplant like infections due to low immune cell counts, graft-versus-host disease where donor cells attack the patient's body, and organ inflammation. The exact side effects will depend on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Acute Myeloid Leukemia.
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My cord blood comes from a bank approved by FACT, FDA, or eligible for NMDP IND.
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I am mostly able to care for myself.
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My initial cancer treatment did not result in complete remission.
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My acute lymphoblastic leukemia is high risk and has a poor prognosis after standard transplant.
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My condition hasn't worsened after 6 treatments with a specific medication.
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My condition is in or beyond the second complete remission.
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My CMML is classified as high or intermediate-2 risk.
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My condition relapsed after a stem cell transplant.
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My cancer did not fully respond to my first intense chemotherapy treatment.
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My condition worsened despite treatment with azacitidine.
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My kidneys are functioning well.
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My condition is high-risk acute leukemia or myelodysplasia.
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My cord blood comes from a bank approved by FACT, FDA, or NMDP.
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I am between 18 and 70 years old.
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I have 2 cord blood units that are a good match for me.
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My cancer has a TP53 mutation.
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I am 40 or older and have a RAS or JAK2 mutation.
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My leukemia is in second remission without favorable genetics.
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My initial cancer treatment was not successful after two tries.
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My blood sample was processed to remove red cells before freezing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Relapse Free survival (RFS)
Transplant Related Mortality (TRM)
Secondary outcome measures
Adverse events grade 3 or higher
Graft failure
Hospitalization events
+6 more
Other outcome measures
Graft composition and evaluation
Identify markers suggesting escape from the immune system
Immune reconstitution

Trial Design

1Treatment groups
Experimental Treatment
Group I: Main interventionExperimental Treatment1 Intervention
Eligible patients will receive an ablative conditioning regimen and be infused with an ECT-001 expanded cord-blood. The ECT-001 expanded CB could be infused fresh, or cryopreserved.

Find a Location

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
70 Previous Clinical Trials
5,530 Total Patients Enrolled
Stem Cell NetworkOTHER
8 Previous Clinical Trials
565 Total Patients Enrolled
ExCellThera inc.Industry Sponsor
4 Previous Clinical Trials
62 Total Patients Enrolled

Media Library

Transplant with an expanded ECT-001 cord blood (Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT03913026 — Phase 2
Blood Cancers Research Study Groups: Main intervention
Blood Cancers Clinical Trial 2023: Transplant with an expanded ECT-001 cord blood Highlights & Side Effects. Trial Name: NCT03913026 — Phase 2
Transplant with an expanded ECT-001 cord blood (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03913026 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its endorsement to utilizing ECT-001 cord blood for transplantation?

"Data from Phase 2 trials suggest that Transplant with an expanded ECT-001 cord blood is safe, so this intervention received a score of 2."

Answered by AI

Are there any vacancies open to prospective participants in this clinical trial?

"As per the details on clinicaltrials.gov, this research project is currently open to new participants. The trial was initiated in April of 2019 and last updated in August 2021."

Answered by AI

What is the current patient population for this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this trial is actively looking for people to participate in the study which was initially posted on April 1st 2019 and had its latest update on August 2nd 2021. 20 individuals need to be recruited from a single medical centre."

Answered by AI

Does the age bracket of this trial encompass those greater than two decades old?

"This clinical trial is open to patients aged 18 and above, with the upper limit for enrollment set at 70 years old."

Answered by AI

Is participation in this research trial open to me?

"To participate in this trial, individuals must have undergone a cord blood transplant and be between 18-70 years of age. Currently, the research team is looking to recruit approximately 20 people."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
UM171 Expanded Cord Blood In Patients With High-Risk Acute Leukemia/Myelodysplasia
Sandra Cohen 2019. "UM171 Expanded Cord Blood In Patients With High-Risk Acute Leukemia/Myelodysplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03913026.
~2 spots leftby Oct 2024
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