Stem Cell Transplant with CliniMACS CD34 Reagent System

This study is for patients who need a stem cell transplant but don't have a perfectly matched donor. It uses a special machine called the CliniMACS CD34 Reagent System to prepare stem cells from a close relative. This machine separates the stem cells from other white blood cells using a special protein (CD34 antibody). The goal is to see how well the new stem cells grow (engraftment) and to check for a common complication called acute GvHD (Graft-versus-Host Disease, where the donor cells attack the patient's body). You can join if you need an allogeneic (from a donor) stem cell transplant, are between birth and 70 years old, and can sign the consent form. The study is currently unclear about its recruitment status.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 241 participants.
What's involved
You will have follow-up exams on days 28, 60, 100, 180, and 365 after the transplant. Health information will be collected for one year after the stem cell infusion.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately one year after the stem cell infusion, with specific evaluations up to 365 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01189786

Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection

Recruiting
NAUp to 70InterventionalTreatment
Baylor College of Medicine
~241 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:CliniMACS CD34 Reagent system

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
For Cohort 1: the rate of primary engraftment 50 days post SCT
Measured over 50 days
+1 more outcome measured
Stem Cell Transplant
Allogeneic

NCT01189786

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Houston Methodist Hospital

    Houston, Texasstudy coordinator listed

    Recruiting

  • Texas Children's Hospital

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Robert Krance, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Opens a ready-to-send draft in your own email app — review before sending.

  • For Cohort 1: the rate of primary engraftment 50 days post SCT50 days

    Primary engraftment is defined as achievement of absolute neutrophil count (ANC) is greater than or equal to 500/ul for three consecutive days by day 50 post transplant. The treatment regimen will be considered clinically useful if the primary engraftment rate is at least 85%.

  • For Cohort 2 (Without Conditioning) and Cohort 3 (With Conditioning): The total incidence of overall acute GvHD (greater than or equal to grade 3)100 days

    The overall incidence of acute GvHD will be measured 100 days post stem cell transplant. The regimen will be considered acceptable if aGvHD greater than or equal to grade 3 rate is at least 10% or lower.