RecruitingNot ApplicableNCT01189786

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

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


Sponsor

Baylor College of Medicine

Enrollment

241 participants

Start Date

Oct 1, 2010

Study Type

INTERVENTIONAL

Conditions

Summary

Participants are being asked to take part in this study because treatment of his or her disease requires a stem cell transplant. Stem cells or "mother" cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation. Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother) for the participant and his or her disease does not permit enough time to identify another donor (like someone from a registry list that is not his or her relative) or another suitable donor has not been identified. However, a close relative of the patient has been identified whose stem cells are not a perfect match, but can be used. Alternatively, the patient may have already received a stem cell transplant but have evidence of mixed chimerism, which means some of the patient's own bone marrow cells are present, rather than all of the donor's cells. This may lead to an increased risk of the disease coming back. Or, the patient may have all donor cells but his or her bone marrow is not working very well, which may lead to frequent blood or platelet (cells that help in clotting blood) transfusions or infection. Regardless of the reason, it may be necessary to isolate stem cells from a haploidentical (half-match) donor in order to provide bone marrow function. Because the stem cells from the donor are only half-matched to the participant, the risk of graft-versus-host disease (GvHD) is very high. GvHD is a complication after transplant caused by donor T cells (graft) that attack the transplant recipient, and this complication can cause death after transplant. Thus, it is important that the donor's blood cells are treated to minimize cells that are most likely to attack the host's tissues. This is done by using a special device to capture the CD34+ stem cells from the donor's stem cell product prior to giving the cells to the host. This method minimizes the donor T cells, which are responsible for causing GvHD. Purpose: In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure, investigators would like to specially treat the donor's blood cells to minimize the cells that are most likely to attack the patient's tissues.


Eligibility

Max Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study looks at a method of preparing stem cells for transplant by removing T-cells (immune cells that can attack the recipient's body) using a process called CD34+ selection. It enrolls patients needing a bone marrow or stem cell transplant, as well as patients who have already had a transplant and need additional cellular therapy to improve outcomes — for example, if their bone marrow isn't functioning well or the donor cells aren't fully taking hold. You may be eligible if... - You need an allogeneic (donor) stem cell transplant (Cohort 1) - You have already had a transplant and need additional stem cells due to mixed chimerism, poor bone marrow function, or disease relapse (Cohorts 2 or 3) - You are between birth and 70 years of age - You or a guardian can provide informed consent You may NOT be eligible if... - You have active, severe graft-versus-host disease (GvHD grade II or higher) - You have a severe, life-threatening infection - You have significant heart or lung dysfunction - You are HIV positive - You are pregnant - Your performance score (Lansky or Karnofsky) is below 50% Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECliniMACS CD34 Reagent system

A special machine that separates out the donor cells that have been mixed with a special protein, CD34 antibody, that binds to the stem cells from the white blood cells.


Locations(2)

Houston Methodist Hospital

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT01189786


Related Trials