How to Use a Medical Device That Helps Prepare Stem Cells for Transplant to Treat Patients and Prevent Graft vs Host Disease (GvHD) During the Transplant Process
Phase: Recruiting
First Posted: March
Condition(s): Allogenic Hemotopoietic Stem Cell Transplantation
Other Study ID Number(s): CD34 Selection
What Is the Purpose of This Study?
To study how using a special medical device called the CliniMACS® CD34 Reagent System. This device is approved for humanitarian use, meaning it's used in specific situations where no other treatments are available. It's designed to prevent a serious complication called Graft vs Host Disease (GvHD), which can occur after a type of stem cell transplant known as allogeneic hematopoietic stem cell transplantation (HSCT).Who Can Take Part in This Study?
- AML patients needing HSCT in first CR from MSD, with no post HSCT GvHD prophylaxis
- Primary or secondary graft failure after allogenic HSCT
- Poor graft function after allogeneic HSCT
- Graft source for allogeneic HSCT
What Will Happen During This Study?
- The CliniMACS® CD34 Reagent System will prepare the stem cells by removing T Cells (immune cells) from the donor’s sample before giving the stem cells to the patient. The machine doesn’t come into direct contact with the patient.
- Patients do not receive normal immunosuppressant medicine after getting the stem cells but are watched more closely for post-transplant infections. Otherwise, the plan of care is the same as a normal transplant.
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