Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
OTHER_GRANT · Spanish Ministry of Health, Programa de Terapias Avanzadas
REGISTRY · Protocol Code
interventional
11
1 country
3
Study Start
April 2011
Actual (reported)Primary Completion
April 25, 2016
Actual (reported)Study Completion
April 25, 2016
Actual (reported)This trial pretends to validate for clinical use a bioengineered product composed of MSV cells (mesenchymal stem cells produced by IBGM, Valladolid, which have already been approved by the Spanish Regulatory Agency for three previous clinical trials) and a cross-linked matrix of autologous plasma patented by The Blood and Tissue Bank of Asturias (WO2008/ 119855) for bone maxillary cysts refilling. These two groups collaborate in the present project with the team of Maxillofacial Surgery of the Hospital Universitario del Río Hortega, who leads the clinical trial and deals with the medical aspects. The proposed trial is based on positive results obtained in previous animal studies performed by the present multidisciplinary team. The investigators propose a phase I / II clinical trial with 10 patients suffering from bone cysts in the maxillofacial region. Autologous mesenchymal stem cells isolated from a bone marrow sample will be seeded in the autologous plasma matrix and cultivated for 3 weeks. At this time, the cyst will be removed by surgery and the cavity filled with the protein matrix containing the mesenchymal cells. Checks will be conducted at 3 weeks, 3 and 6 months following the evolution of the cavity by panoramic radiography and computerized tomography scan.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 25, 2016
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2011
Actual (reported)July 5, 2011
Actual (reported)July 8, 2011
Actual (reported)April 25, 2016
Actual (reported)April 25, 2016
Actual (reported)To evaluate the feasibility and safety of the implementation of MSV in the treatment of maxillary cysts
Clinical review and orthopantomograpy at different periods (0, 2 weeks, 2 months and 6 months) assessing evolution from baseline and possible complications.
up to 6 months
Indication of efficacy
up to 6 months
MSV treatment: Mesenchymal stem cells from bone marrow expanded by GMP-compliant procedure in IBGM cell production unit in autologous plasma scaffold and implanted in maxillary bone cavities after cyst removal
Autologous maxillary bone marrow mesenchymal stem cells (MSV-H) collected from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Río Hortega University Hospital
Valladolid, Valladid, 47012, Spain
Bionand, Parque Tecnológico de Andalucía, Universidad de Málaga
Málaga, Spain
Instituto de Biologia y Genetica Molecular
Valladolid, 47003, Spain
Redondo LM, Garcia V, Peral B, Verrier A, Becerra J, Sanchez A, Garcia-Sancho J. Repair of maxillary cystic bone defects with mesenchymal stem cells seeded on a cross-linked serum scaffold. J Craniomaxillofac Surg. 2018 Feb;46(2):222-229. doi: 10.1016/j.jcms.2017.11.004. Epub 2017 Nov 16.
Luis M Redondo, MD, PhD
Oral and Maxillofacial Surgeon, Río Hortega University Hospital, SACYL, Valladolid, Spain
Ana Sánchez, MD, PhD
Instituto de Biología y Genética Molecular (IBGM), University of Valladolid, Spain
Javier García-Sancho, MD, PhD
University of Valladolid, Spain
Jose Becerra, PhD
Centro Andaluz de Nanomedicina y Biotecnología (BIONAND), Universidad de Málaga, Ciber-bbn. Málaga, Spain.
11 participants (actual enrollment reported by the registry).
First Submitted
July 5, 2011
First Posted
July 8, 2011
Study Start
April 2011
Contact the study team to confirm eligibility.
Primary Completion
April 25, 2016
Actual (reported)Study Completion
April 25, 2016
Actual (reported)Last Updated
April 27, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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