Treatment Of Maxillary Bone Cysts With Autologous Bone Mesenchymal Stem Cells (MSV-H)

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.

Conditions

• Maxillary Cyst
• Bone Loss of Substance

Interventions

BIOLOGICAL

MSV treatment

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)

Sponsors & Collaborators

• Sanidad de Castilla y León

  collaborator OTHER

• University of Valladolid

  collaborator OTHER

• Centro en Red de Medicina Regenerativa de Castilla y Leon

  collaborator OTHER

• Citospin

  collaborator INDUSTRY

• Red de Terapia Celular

  lead INDUSTRY

Principal Investigators

• 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.

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2016-04-25

Completion

2016-04-25

Countries

• Spain

Study Locations