Actively Recruiting
Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection (EXCESS)
Led by Baylor College of Medicine · Updated on 2025-12-03
241
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
C
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a special method of treating donor stem cells to reduce the risks of graft-versus-host disease (GvHD) and transplant failure in patients needing a stem cell transplant. The study includes patients whose disease requires transplantation but lack a perfectly matched donor, or who have had a previous transplant with mixed donor and patient bone marrow cells or poor bone marrow function. The goal is to improve transplant outcomes by minimizing donor cells that may attack the patient’s tissues. Participants receive stem cells collected from a close relative donor through a device called the CliniMACS CD34 Reagent System. This machine separates stem cells by binding them to a special protein, reducing the donor T cells that cause GvHD. The study has three groups: Cohort 1 includes patients receiving a transplant after conditioning treatment; Cohort 2 includes patients needing extra stem cells without conditioning; Cohort 3 includes patients needing extra stem cells with conditioning. The stem cells may be given fresh or frozen. Participants will have follow-up exams around days 28, 60, 100, 180, and 365 after transplant to monitor transplant success and any complications like GvHD or infections. Health information will be collected for one year to assess survival, relapse, and adverse events. Those without GvHD may have fewer tests. The study lasts about one year, focusing on the rate of stem cell engraftment and the severity of acute GvHD.
CONDITIONS
Brief Title
Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient requiring allogeneic stem cell transplant or additional cellular therapy
- Age between birth and 70 years
- Patient and/or responsible person able to understand and sign consent
- For patients receiving CD34+ topoff: at least one of the following must apply: evidence of mixed chimerism, poor bone marrow function, or relapsed/persistent disease
You will not qualify if you...
- Active, acute graft-versus-host disease greater than grade II or extensive chronic graft-versus-host disease
- Severe life-threatening infection
- Pulmonary dysfunction (FEV1, FVC, or DLCO 40% of predicted or 3 SD below normal) for certain cohorts
- Cardiac dysfunction (LVSF less than 25%) for certain cohorts
- Psychiatric disturbance
- Lansky or Karnofsky score less than 50%
- Severe hepatic disease (direct bilirubin greater than 3x upper limit of normal and AST greater than 5x upper limit of normal)
- Creatinine greater than 3x normal
- Known HIV positivity
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (transplant day)
Participants receive a stem cell transplant using CD34-selected peripheral blood stem cells, with or without a conditioning regimen depending on their cohort. The stem cells are collected from a donor and processed using the CliniMACS CD34 Reagent System before infusion.
1 transplant visit (in-person)
Duration - Up to 1 year after transplant
Participants will have follow-up exams and assessments approximately on days 28, 60, 100, 180, and 365 after the transplant to monitor health status, survival, relapse, infections, and graft-versus-host disease (GvHD). Participants who do not develop GvHD may not require all these tests.
About 5 follow-up visits (in-person)
Trial Site Locations
Total: 2 locations
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
2
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Robert Krance, MD
M
Marlen Dinu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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