Treatment Of Maxillary Bone Cysts With Autologous Bone Mesenchymal Stem Cells (MSV-H)
Condition: Maxillary Cyst; Bone Loss of Substance
MeSH terms: Cysts; Bone Cysts
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MSV treatment
Intervention type(s): Biological
Intervention description(s): 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)
Other intervention name(s): H-MSV, Human Mesenchymal Stem Cells from Valladolid
Intervention model: Single Group Assignment
Intervention model description: MSV-H autologous transplantation: 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
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Maxillary bone cysts; Cell therapy; Mesenchymal stem cells; Autologous serum scaffold