A phase I/II Study evaluating the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after partially HLA compatible allogeneic hematopoietic stem cell transplantation in SCID patients - HTLP NECKER

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 12 人开始时间: 2018年7月2日最近更新: 2018年11月6日

适应症

试验速览

暂无简介。

•Pediatric patients affected by any type of SCID confirmed by clinical, immunological and/or molecular diagnosis and eligible for an allogeneic HSCT
•Absence of a matched sibling donor or a matched unrelated donor (MUD) 10/10
•Clinical conditions incompatible with the search of a MUD
•Written, informed consent of parents/ legal representative (child)
•Age = 2 years at the time of screening
•No prior therapy with allogeneic stem cell transplantation
•No treatment with another investigational drug within one month before inclusion
•Injection occurs 7 days prior to HSCT with CD34+ selected graft if all inclusion criteria are met
•Patient affiliated to social security
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 12
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Presence of an HLA genoidentical donor
•Absence of written parental consent
•Treatment with another investigational drug within one month before inclusion
•Positive for HIV infection by genome PCR
•Contra-indication to allogeneic transplantation or conditioning therapy (except SCID patients with DNA repair deficiency)

发起方