A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant

Launched by CHRISTOPHER DVORAK · Apr 3, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to reduce the risk of graft-versus-host disease (GVHD) in patients receiving stem cell transplants. GVHD can occur when the donated cells attack the recipient's body. The study is testing a device called CliniMACS® to remove certain immune cells (alpha-beta T-cells) from the donor’s cells before the transplant. This process is aimed at making the transplant safer for the patient. However, because the CliniMACS® device is only approved for specific cases, this study is necessary to see if it can be used more broadly.

To participate in this trial, individuals must be between 0 and 30 years old and need a stem cell transplant for a serious illness. They must also have a healthy donor who can provide bone marrow or blood stem cells. Participants will go through a thorough screening process, and both patients and their families must consent to the study's requirements. It’s important to note that certain individuals, such as pregnant women or those with specific health issues, may not be eligible. Overall, if you or a family member are considering participating, the study aims to offer a safer option for stem cell transplants, with careful guidance from medical professionals throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female 0-30 years of age at time of transplant admission
• • Documentation of a disease requiring HCT
• • A donor (mismatched related or unrelated) must be located who are healthy and willing, and whom are able to donate bone marrow (BM) or peripheral blood stem cells (PBSC). Matched related donors may be used for patients with Fanconi Anemia.
• • Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
• Exclusion Criteria:
• • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
• • Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia).
• • Patient with an anticipated life expectancy of \<1 month
• • Patients with known hypersensitivity to murine (mouse) proteins or iron dextran