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Cell Depletion

Stem Cell Selection for Blood Diseases

Valhalla, NY
Phase 2
Recruiting
Research Sponsored by Mitchell Cairo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
6. Sickle Cell Disease (Homozygous Hemoglobin S Disease, or Hemoglobin S β 0/+ thalassemia, or Hemoglobin SC Disease)
High Risk Myelodysplastic syndrome (MDS)
Must not have
Patients with documented uncontrolled infection at the time of study entry are not eligible.
Females who are pregnant or breast-feeding are not eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial is testing a new stem cell selection method for children, adolescents, and young adults undergoing an AlloSCT. The new method uses α/β CD3+/CD19+ cell depletion to select the stem cells, and all other treatment is standard of care.

See full description
Who is the study for?
This trial is for children and young adults (0-30 years) with various blood diseases, including high-risk acute leukemia, lymphoma, sickle cell disease, and bone marrow failure syndromes. Participants must have adequate organ function and not be pregnant or breastfeeding. They can't join if they've had a recent transplant or uncontrolled infection.Check my eligibility
What is being tested?
The study tests a stem cell transplantation technique using α/β CD3+/CD19+ cell depletion in patients with malignant and non-malignant hematologic conditions. This method aims to improve outcomes by selecting specific cells while maintaining standard care treatments.See study design
What are the potential side effects?
While the description doesn't specify side effects of α/β T-cell depletion, similar procedures may include risks like infections due to lowered immunity, graft-versus-host disease where donor cells attack the body, bleeding complications from low platelet count, and reactions to infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Sickle Cell Disease.
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I have been diagnosed with high-risk Myelodysplastic syndrome.
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I have a bone marrow failure syndrome and treatments haven't worked for me.
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I am 30 years old or younger.
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I have AML and it has not responded well to initial treatments or it has come back.
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My leukemia is considered high risk due to specific genetic features or because it didn't respond well to initial treatment.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any untreated infections.
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I am not pregnant or breastfeeding.
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I need assistance with my daily activities due to my health condition.
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My graft-versus-host disease is mild.
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Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
Secondary study objectives
incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: alpha beta cell depletionExperimental Treatment1 Intervention
Matched allogeneic donor stem cells will be processed utilizing α/β CD3+/CD19+ cell depletion with the Prodigy system. Standard pre-conditioning and post-transplant motioning will be given.

Find a Location

Closest Location:New York Medical College· Valhalla, NY

Who is running the clinical trial?

Mitchell CairoLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Mitchell S CairoStudy ChairNew York Medical College
1 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Alpha/Beta Depletion (Cell Depletion) Clinical Trial Eligibility Overview. Trial Name: NCT04099966 — Phase 2
Acute Leukemia Research Study Groups: alpha beta cell depletion
Acute Leukemia Clinical Trial 2023: Alpha/Beta Depletion Highlights & Side Effects. Trial Name: NCT04099966 — Phase 2
Alpha/Beta Depletion (Cell Depletion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04099966 — Phase 2
~3 spots leftby Dec 2025