Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT
Launched by SIJIA GU · May 15, 2024
Trial Information
Current as of February 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new method for treating children with serious blood disorders through a procedure called haploidentical hematopoietic stem cell transplantation (HSCT). The study compares two types of stem cell transplants: one using a special technique to reduce certain immune cells (called TCRαβ-depleted stem cells) and the traditional method. Researchers want to find out if the new approach is safer and more effective in preventing complications like graft-versus-host disease, where the donor’s immune cells attack the patient’s body.
To participate in this trial, children aged 8 weeks to 18 years who need this type of transplant may be eligible, especially if they do not have a suitable donor with a close match. However, children with certain health issues like severe liver problems, heart failure, or uncontrolled infections cannot join. If a child is accepted into the trial, they will receive either the new or the traditional transplant method and will be closely monitored by medical professionals throughout the process. This study aims to improve treatment options for young patients facing these challenging health conditions.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age 8 weeks to 18 years
- • Children who meet the indicators haploidentical hematopoietic cell transplantation
- • No HLA ≥ 9/10 donor or not suitable for this type of donor due to illness
- • Informed consent must be signed (by the patient or legal representative)
- Exclusion Criteria:
- • Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L
- • Chronic active viral hepatitis
- • Ejection fraction \<50%
- • Respiratory failure necessitating supplemental oxygen
- • Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study
- • Patients unwilling or unable to comply with the protocol or unable to give informed consent
- • Concurrent severe or uncontrolled infection
Trial Officials
Jing Chen, PhD
Principal Investigator
Shanghai Children's Medical Center
About Sijia Gu
Sijia Gu is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on integrity and scientific rigor, Sijia Gu oversees the design, implementation, and management of clinical trials across various therapeutic areas. The organization emphasizes collaboration with healthcare professionals and regulatory bodies to ensure compliance with industry standards and ethical practices. Through a patient-centered approach, Sijia Gu aims to contribute to the development of safe and effective treatments, fostering progress in the healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0