Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
NCT01844661 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2016-02-19
Summary
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.
Conditions
- Children
- Solid Tumors
- Metastases
Interventions
- BIOLOGICAL
-
CELYVIR
Sponsors & Collaborators
-
Instituto de Salud Carlos III
collaborator OTHER_GOV -
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
lead OTHER
Principal Investigators
-
Manuel Ramírez, MD PhD · Hospital Universitario Niño Jesús
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Months
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2014-12-31
- Completion
- 2016-01-31
Countries
- Spain
Study Locations
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