BridgeMD
Linfociti T virus-specifici per infezioni virali resistenti alla terapia farmacologica dopo trapianto allogenico di cellule staminali emopoietiche e in pazienti con grave immunodepressione primitiva o secondaria
EU CTIS ID: 2024-518925-14-02
What this study is testing
The aim of the study is to evaluate the safety of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV), BK that developed in young patients (age between 0 and 30 years) after allogeneic hematopoietic cell transplantation (allo-HSCT).
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Allogeneic transplant with any cells source and conditioning regimen
- Presence of informed consent to the treatment of the patient / parent /legal guardian
- Age between 0-30 years
- Viral infection/reactivation (CMV, EBV, ADV, BK)
- Absence of concomitant severe uncontrolled infections
- Life expectancy exceeding 30 days
You likely can't join if
- Absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test)
- Patient with severe renal and/or hepatic impairment as specified above
- Primary or secondary graft failure
- Relapse of malignant underlying disease
See the full eligibility criteria
- Allogeneic transplant with any cells source and conditioning regimen
- Presence of informed consent to the treatment of the patient / parent /legal guardian
- Age between 0-30 years
- Viral infection/reactivation (CMV, EBV, ADV, BK)
- Absence of concomitant severe uncontrolled infections
- Life expectancy exceeding 30 days
- Absence of acute or chronic uncontrolled Graft versus Host Disease (GvHD)
- Absence of acute kidney damage (creatinine value> 3 times the value normal with respect to age) not related to viral infection
- Absence of severe acute liver injury (direct bilirubin> 3mg / dl or glutamicoxaloacetic transaminase -SGOT> 500 UI/L) not related to viral infection
- Absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test)
- Patient with severe renal and/or hepatic impairment as specified above
- Primary or secondary graft failure
- Relapse of malignant underlying disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.