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Stem Cell Therapy

Expanded Cord Blood Transplant for High-Risk Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by ExCellThera inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1- and 2-year post-transplant
Awards & highlights

Study Summary

This trial is testing a new way to expand cord blood cells that may help more people with high risk myeloid malignancies. If the first stage is promising, the study will be extended to more patients.

Who is the study for?
This trial is for pediatric and young adult patients with high-risk myeloid malignancies, such as Acute Myeloid Leukemia or Chronic Myelogenous Leukemia in blast crisis. Participants need a suitable cord blood match, good organ function, and no uncontrolled infections or other recent treatments that could affect the study.Check my eligibility
What is being tested?
The trial tests ECT-001-CB (UM171-Expanded Cord Blood Transplant) to improve outcomes of cord blood transplants by increasing cell dose and reducing complications like graft-versus-host disease. The first stage includes 12 patients; if successful, it will expand to more centers with additional participants.See study design
What are the potential side effects?
Previous trials suggest side effects may include low risk of severe acute or chronic graft-versus-host disease, reduced severe viral/bacterial infections, and potential for early discontinuation of immunosuppression. Specific side effects for this age group will be monitored.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1- and 2-year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1- and 2-year post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events of ECT-001-CB
Relapse
Secondary outcome measures
GVHD
Communicable Diseases
Hematologic engraftment
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ECT-001-Expanded CBExperimental Treatment1 Intervention
Patients will receive a myeloablative conditioning regimen (Preferred: Clo/Flu/Bu90, Alternative: MIDI) The cord to be expanded will undergo CD34+ selection. The CD34- product is cryopreserved and will be thawed and infused on Day +1 post-transplant. The CD34+ product will be placed in a closed culture with UM171 for a 7-day expansion and is infused on Day 0. Patients will receive standard supportive care and GVHD prophylaxis (such as MMF and tacrolimus).

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterOTHER
1,936 Previous Clinical Trials
588,886 Total Patients Enrolled
ExCellThera inc.Lead Sponsor
4 Previous Clinical Trials
80 Total Patients Enrolled
2 Trials studying Cord Blood Transplant
60 Patients Enrolled for Cord Blood Transplant

Media Library

ECT-001-CB (UM171-Expanded Cord Blood Transplant) (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04990323 — Phase 1 & 2
Cord Blood Transplant Research Study Groups: ECT-001-Expanded CB
Cord Blood Transplant Clinical Trial 2023: ECT-001-CB (UM171-Expanded Cord Blood Transplant) Highlights & Side Effects. Trial Name: NCT04990323 — Phase 1 & 2
ECT-001-CB (UM171-Expanded Cord Blood Transplant) (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04990323 — Phase 1 & 2

Frequently Asked Questions

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

Has there been prior research conducted on the efficacy of ECT-001-CB (UM171-Expanded Cord Blood Transplant)?

"Currently, there are 1007 studies concerning ECT-001-CB (UM171-Expanded Cord Blood Transplant), with 178 of them in the Phase 3 stage. Of those clinical trials, Philadelphia Pennsylvania has the highest concentration; however 29597 locations worldwide offer research for this experimental therapy."

Answered by AI

How many volunteers have enrolled in this research endeavor?

"Affirmative. According to clinicaltrials.gov information, this medical research is actively looking for participants with the trial first being posted on December 1st 2021 and updated most recently on January 12th 2022. This study needs approximately twelve people at a single site."

Answered by AI

What criteria must a candidate meet to partake in this clinical experiment?

"This clinical trial seeks 12 pediatric patients, aged 0 to 21 years old and who have undergone a cord blood transplant. Additional criteria that must be met include relapse after allogeneic or autologous transplants greater than 4 months post-transplant as well as secondary or therapy-related myelodysplastic syndrome/acute myeloid leukemia."

Answered by AI

Does this research opportunity include persons of advanced years?

"The parameters for inclusion in this medical trial are those aged between 0 to 21. The database hosted on clinicaltrials.gov reports 648 studies involving minors and 2953 related to seniors over 65 years old."

Answered by AI

What medical maladies does ECT-001-CB (UM171-Expanded Cord Blood Transplant) typically alleviate?

"Patients suffering from leukemia, refractory langerhans cell histiocytosis, and lung cancers have the potential to benefit from ECT-001-CB (UM171-Expanded Cord Blood Transplant)."

Answered by AI

Is the enrollment period still open to participants of this experiment?

"As per the details available on clinicaltrials.gov, signups for this medical trial have commenced as of December 1st 2021 and are ongoing; with the most recent update being posted on January 12th 2022."

Answered by AI

What goals are being sought after with the implementation of this experiment?

"According to the trial sponsor, ExCellThera inc., this 100-day assessment will focus on measuring relapse as its primary outcome. Moreover, other secondary objectives include determining pre-engraftment/engraftment syndrome requiring therapy, hospitalization events in relation to transplant admission and fever levels prior to engraftment, and assessing acute and chronic GVHD per NIH criteria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
US Study of ECT-001-CB in Pediatric and Young Adult Patients With High-Risk Myeloid Malignancies
2021. "US Study of ECT-001-CB in Pediatric and Young Adult Patients With High-Risk Myeloid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04990323.
~6 spots leftby Jun 2026
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