Maxillary Cyst Clinical Trial
Official title:
Regeneration of Maxillary Bone Cystic Cavities by Bio Implant of MSHV-H Cells Associated to a Cross-linked Serum Scaffold
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.
The objective of this project is to provide a competitive clinical solution with an
autologous product, a balanced cost and the possibility of extending use to other
pathologies.
This protocol includes treatment of 10 patients with cystic disease of the jaws that meet
all the inclusion criteria and none of the exclusion criteria.
For autologous cell preparation a sample of spongy bone from the maxillary tuberosity and 20
ml of serum are obtained from the patient in order to prepare the crosslinked protein matrix
and the MSV-H cells. Cells are selected and expanded under GMP conditions according to the
methodology used in previous trials (EudraCT 2005-005498-36, 2008-001191-68 and
2009-0170450-11 ). MSV-H cells are obtained directly from biopsy culture jawbone of the
patient by cultivation techniques "in vitro" and differentiate for 21 days once conveyed in
the matrix with osteogenic differentiation medium of the following composition: DMEM, 10%
FBS, 1% P / E, 0.1 mM dexamethasone, 50 mM ascorbate 2-phosphate, 10 mM phosphate ßGlicerol.
All differentiation factors have already been approved for clinical use. After the period of
the product differentiation can be implanted to the patient.
The bioimplant is used to refill the bone defects after osteotomy and maxillary cyst
enucleation, with 5-10 million cells per unit of 2 cm in diameter and 0.3 cm thick. The
cavity is closed with the mucoperiosteal flap and sutured with reabsorbable material. The
end point of the trial is to evaluate the feasibility, safety and indications of treatment
efficacy according to both clinical criteria and objective imaging confirming the volumetric
bone regeneration and maintenance over time. For this purposes orthopantomography
exploration will be performed before and 2 and 6 months after intervention.
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