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Cell Therapy

Standardized T Cell Dose for Bone Marrow Transplant

N/A
Waitlist Available
Led By Ayman Saad, MD
Research Sponsored by Donna Salzman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram
Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula
Must not have
Prior autologous or allogeneic transplantation for any disease
Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether standardizing the number of immune cells in stem cell transplants from siblings can improve outcomes for patients.

Who is the study for?
This trial is for adults over 19 who need a bone marrow transplant and have a perfectly matched sibling donor. They should fit specific health criteria, like good heart, kidney, lung function, and overall strength (Karnofsky ≥ 70%). People with previous transplants, certain high-risk disease features or uncontrolled infections can't join.
What is being tested?
The study tests if standardizing the dose of immune cells (CD3+ T cells) in stem cell transplants from siblings makes treatment outcomes more predictable and manageable. It aims to see if this approach benefits patients by reducing complications.
What are the potential side effects?
While not explicitly listed here, side effects may include typical transplant-related risks such as infection due to immune suppression, graft-versus-host disease where the new cells attack the body's tissues, and other organ-specific issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's pumping ability is normal or above normal.
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My kidney function, measured by creatinine clearance, is good.
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I am able to care for myself but may not be able to do active work.
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My liver function tests are within normal limits.
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I am 19 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a stem cell transplant before.
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I do not have any uncontrolled infections.
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I am scheduled for a mild bone marrow transplant procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CD3+ T-cell depletionExperimental Treatment1 Intervention
CD3+ T-cell depletion

Find a Location

Who is running the clinical trial?

Donna SalzmanLead Sponsor
University of Alabama at BirminghamLead Sponsor
1,642 Previous Clinical Trials
2,332,549 Total Patients Enrolled
Miltenyi Biotec, Inc.Industry Sponsor
10 Previous Clinical Trials
258 Total Patients Enrolled

Media Library

CD3+ T cell depletion (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00959140 — N/A
Bone Marrow Transplant Research Study Groups: CD3+ T-cell depletion
Bone Marrow Transplant Clinical Trial 2023: CD3+ T cell depletion Highlights & Side Effects. Trial Name: NCT00959140 — N/A
CD3+ T cell depletion (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00959140 — N/A
~0 spots leftby Dec 2024
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