Quality Technical Agreement for Thymus Fragments collection
J
Jeremy Herrmann, MD
Primary Investigator
Enrolling By Invitation
15 years or below
All
Phase
N/A
1 participants needed
1 Location
Brief description of study
What is the purpose of this study?
SANOFI Genzyme collects thymus fragments from pediatric cardiothoracic centers. These thymus fragments are used for the extraction of thymocytes to manufacture the medicine named Thymoglobuline. This medication is used in organ transplantation and in hematological disorders.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects will be identified by review of medical history by the doctor or his staff. Potential subjects and/or their parents will discuss participation with the doctor or his staff during office visits related to the surgery or during pre-op.
Detailed description of study
What will happen during the study?
This is a thymus fragments collection collaboration intended to collect biospecimens which can be used to manufacture the medicine named Thymoglobuline. it is being submitted per direction of Kanti Cain. During paediatric cardiothoracic surgery, partial thymectomy is performed at the discretion of the surgeons, to facilitate access to the large vessels in close proximity to the heart. The thymus fragment removed can either be destroyed or used to manufacture a medicine essential in transplantation and haematology. Considering thymus fragments are the only source of thymocytes which can be used for the industrial manufacturing of this medicine, SANOFI Genzyme has set up a collaboration with some cardiothoracic surgical centres in the whole world.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: all, Riley
-
Age: 15 years or below
-
Gender: All
Inclusion criteria:
- Check performed by the surgical team before the admission and during the
surgery. - Thymus fragments collected by SANOFI Genzyme may only come from children under 15 years
of age.
Exclusion criteria:
- Children suffering from infectious viral diseases, such as HIV 1 or HIV 2; HBV and HCV; HTLV I and HTLV II and syphilis,
- Children having received natural growth hormone treatment, as part of the treatment of pituitary dwarfism,
- Children with clinical criteria or a history indicating a potential risk of transmission of Creutzfeldt-Jakob disease or of other transmissible subacute spongiformencephalopathies.
Updated on
21 Apr 2025.
Study ID: SURG-SANOFI-THYMUS-DONATION, 23640
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