Safety and Efficacy Study of Human T Lymphoid Progenitor (HTLP) Injection After Partially HLA Compatible Allogeneic Hematopoietic Stem Cell Transplantation in SCID Patients
NCT ID: NCT03879876
Last Updated: 2022-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2020-05-13
2025-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Human T Lymphoid Progenitor (HTLP) injection
Human T Lymphoid Progenitor cells (HTLPs) obtained after a brief period of ex vivo culture in the presence of the fusion protein DL-4, Retronectin® and a combination of cytokines
Human T Lymphoid Progenitor (HTLP) injection
Injection of progenitors derived from HTLP culture at Day 8-Day 12 after partially HLA compatible allogeneic hematopoietic stem cell transplantation in SCID patients (Day7 of culture)
Interventions
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Human T Lymphoid Progenitor (HTLP) injection
Injection of progenitors derived from HTLP culture at Day 8-Day 12 after partially HLA compatible allogeneic hematopoietic stem cell transplantation in SCID patients (Day7 of culture)
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient affiliated to social security
Exclusion Criteria
* 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)
2 Years
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Isabelle ANDRE, PhD
Role: STUDY_DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Despina MOSHOUS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris and Université Paris Descartes
Locations
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Unité d'Immunologie Hématologie Rhumatologie Pédiatrique (UIHR),
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-001029-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P150949J
Identifier Type: -
Identifier Source: org_study_id
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