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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. In addition to data on toxicities the investigators will evaluate clinical response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CELYVIR | Experimental | Patients will received weekly (n=6) IV infusion of Celyvir. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CELYVIR | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects after intravenous infusions | We will record any sign or symptom that could be related to the infusion of Celyvir. | 48 hours after each infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression. | Up to 2 months after the last infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Ramírez, MD PhD | Hospital Universitario Niño Jesús | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Niño Jesús | Madrid | Madrid | 28009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33737338 | Derived | Morales-Molina A, Gambera S, Leo A, Garcia-Castro J. Combination immunotherapy using G-CSF and oncolytic virotherapy reduces tumor growth in osteosarcoma. J Immunother Cancer. 2021 Mar;9(3):e001703. doi: 10.1136/jitc-2020-001703. | |
| 32053771 | Derived | Ruano D, Lopez-Martin JA, Moreno L, Lassaletta A, Bautista F, Andion M, Hernandez C, Gonzalez-Murillo A, Melen G, Alemany R, Madero L, Garcia-Castro J, Ramirez M. First-in-Human, First-in-Child Trial of Autologous MSCs Carrying the Oncolytic Virus Icovir-5 in Patients with Advanced Tumors. Mol Ther. 2020 Apr 8;28(4):1033-1042. doi: 10.1016/j.ymthe.2020.01.019. Epub 2020 Jan 21. |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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