Overview
A safety and efficacy clinical study of a lentiviral vector to transfer IL2RG complementary DNA to bone marrow stem cells in ten children with genetic diagnosed X-SCIDsevere combined immune deficiency .The ten children will be followed for 3-5 years and be evaluated by clinical characteristics, vector marking (vector copy number per cell) in blood and bone marrow cells, immune reconstitution vector insertion-site patterns and so on.
Eligibility
Inclusion Criteria:
- X-SCID patients diagnosed by IL2RG single gene mutation
- No HLAhuman leukocyte antigen matching donor
- Hematopoietic stem cell transplantation failed and the time from transplantation was more than 18 months
- Severe and persistent refractory infections
- Life expectancy of > : 4 months
- HIV PCR in peripheral blood was negative
- the children and their families signed informed consent and were willing to enter the clinical trial and complete follow-up
Exclusion Criteria:
- The patient has diagnosed with hematological malignant diseases
- Received chemotherapy within 3 months
- HIV infection or HBVhepatitis B virus infection
- The patient or his first-degree relative has developed a malignant tumor within the age of 18 or has been diagnosed with malignant tumor prone genes
- Although the patient with X-SCID was diagnosed as IL2RG single gene mutation , the clinical phenotype was not severe, so they could continue to wait for the donor search;
- Patients whose family members have no intention to continue the follow-up treatment in any link