Clinical Study of Super Transplantation in the Treatment of Severe β-thalassemia

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a single-arm, open label, phase 1 study in subjects with beta-thalassemia. This study will evaluate the safety and efficacy of preconditioning-free super-transplantation on beta-thalassemia pediatric patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 10
Healthy Volunteers: f
View:

• Diagnosis of severe β -thalassemia

• Age between 7-10 years old, male and female; Weight \< 40kg

• The patient has or does not have an HLA-compatible or semi-compatible donor, but unconditional transplantation or refusal of blood stem cell transplantation; Patients with thalassemia gene therapy without conditions or refusal;

• There are fully compatible or incompatible HLA donors, and the physical examination meets the donor conditions;

• The patient and family members agree to receive hypertransplant therapy and sign a written informed consent prior to the transplant trial.

Locations
Other Locations
China
Guangzhou Women and Children's Medical Center Affiliated to Guangzhou Medical University
RECRUITING
Guangzhou
Guangzhou Women and Children's Medical Center Affiliated to Guangzhou Medical University
ACTIVE_NOT_RECRUITING
Guangzhou
Contact Information
Primary
Hua Jiang, Doctor
jiang_hua18@sina.cn
86-020-38076501
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 3
Treatments
Experimental: Severe β -thalassemia
Children with β-thalassemia major received super transplantation, and chimerism tests were performed at 3 months, 6 months, 9 months, and 1 year after transplantation to evaluate the safety and effectiveness.
Sponsors
Leads: Guangzhou Women and Children's Medical Center

This content was sourced from clinicaltrials.gov