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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: SCID pediatric patients (n=12 for analysis) requiring an HLA partially compatible allogeneic HSCT.
Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Enrollment: 12
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

July 2, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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)