Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
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|ClinicalTrials.gov Identifier: NCT01844661|
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : February 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Children Solid Tumors Metastases||Biological: CELYVIR||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||January 2016|
Patients will received weekly (n=6) IV infusion of Celyvir.
Other Name: Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus.
- Adverse effects after intravenous infusions [ Time Frame: 48 hours after each infusion ]We will record any sign or symptom that could be related to the infusion of Celyvir.
- Clinical outcome [ Time Frame: Up to 2 months after the last infusion ]Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844661
|Hospital Universitario Niño Jesús|
|Madrid, Spain, 28009|
|Principal Investigator:||Manuel Ramírez, MD PhD||Hospital Universitario Niño Jesús|