Status:
COMPLETED
Expanded Access Protocol Thymus Transplantation
Lead Sponsor:
Sumitomo Pharma Switzerland GmbH
Conditions:
Poor Thymic Function
Immunodeficiency
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The primary purpose is to provide access for patients who have immunodeficiency or severe autoimmune disease related to poor thymic function to cultured thymus tissue for implantation. With no thymus ...
Detailed Description
The patients enrolled have a high likelihood of death if they do not receive culture thymus tissue because of lack of thymus function. As there are many types of patients who may be enrolled, study re...
Eligibility Criteria
Inclusion
- Cultured Thymus Tissue Inclusion Criteria for Implantation:
- an immunodeficiency or severe autoimmunity for which development of naïve T cells would be expected to lead to lead to clinical improvement.
- written consent (or consent of parent/legal guardian as applicable), review of medical testing, laboratory studies, and physical examinations are used to determine whether the patient is clinically stable and will potentially benefit from receiving cultured thymus tissue. Each participant is reviewed with the Data Safety and Monitoring Board (DSMB).
- Cultured Thymus Tissue Exclusion Criteria for Implantation:
- Unrepaired cyanotic congenital heart disease
- Uncontrolled infections. "Uncontrolled" is defined as requiring a ventilator, dialysis, or vasopressor support or anticipated as requiring such support within 6 months.
- Pregnancy
- For females of child-bearing potential, a serum pregnancy test is done after consent, at the same time another blood draw is done if possible.
- Females of child-bearing potential must agree to contraceptive measures as indicated in the consent form.
- A second serum pregnancy test is done within 48 hours prior to administration of study interventions involving FDA pregnancy class D drugs, chemotherapy drugs, or other drugs or interventions known to pose risks to a potential fetus.
- HIV Positive
- History of malignancy
- CMV Infection
- For subjects receiving immunosuppression as part of the implantation protocol, CMV infection as documented by \>500 copies/ml in blood by PCR on two consecutive assays is an exclusion.
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02274662
Start Date
August 1 2014
End Date
August 1 2023
Last Update
January 16 2025
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