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Trial record 1 of 1 for:    NCT01389661
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Treatment Of Maxillary Bone Cysts With Autologous Bone Mesenchymal Stem Cells (MSV-H) (BIOMAX)

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ClinicalTrials.gov Identifier: NCT01389661
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
Sanidad de Castilla y León
University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Citospin
Information provided by (Responsible Party):
Red de Terapia Celular

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Maxillary Cyst Bone Loss of Substance Biological: MSV treatment Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
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
Official Title: Regeneration of Maxillary Bone Cystic Cavities by Bio Implant of MSHV-H Cells Associated to a Cross-linked Serum Scaffold
Actual Study Start Date : April 2011
Actual Primary Completion Date : April 25, 2016
Actual Study Completion Date : April 25, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MSV treatment
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
 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)
Other Name: H-MSV, Human Mesenchymal Stem Cells from Valladolid


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the feasibility and safety of the implementation of MSV in the treatment of maxillary cysts [ Time Frame: up to 6 months ]
    Clinical review and orthopantomograpy at different periods (0, 2 weeks, 2 months and 6 months) assessing evolution from baseline and possible complications.


Secondary Outcome Measures :
  1. Indication of efficacy [ Time Frame: up to 6 months ]
    Imaging exploration to evaluate effectiveness through development of criteria for orthopantomography and bone-CT quantitative bone regeneration Evolution at 2 and 6 months from intervention will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Maxillar bone cyst with diameter larger than 2 cm and smaller than 4 cm
  • Understanding and written acceptance of assay conditions
  • Informed written consent of the patient for assay and for surgery
  • In women, negative pregnancy test at t=0
  • In women, compromise of using anticonceptive methods during the study

Exclusion Criteria:

  • Age under 18 or over 65
  • Incapacity or legal dependence
  • Pregnancy, lactancy, or enrollment in fertility programs
  • Previous or concomitant oncological processes.
  • Positive serology for HIV-1 orHIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab) or Hepatitis C (Anti-HCV-Ab).
  • Immunocompromised patients
  • Systemic disease with potential effects on bone metabolism
  • Congenital or acquired maxillofacial malformation
  • Patients with prescription of drugs acting on bone metabolism, suc as glucocorticoids and bisphosphonates
  • Active or recent infection of the cyst
  • Recidive of the cyst (previous surgery)
  • Participation in other trials or studies in the last 3 months.
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389661


Locations
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Spain
Río Hortega University Hospital
Valladolid, Valladid, Spain, 47012
Bionand, Parque Tecnológico de Andalucía, Universidad de Málaga
Malaga, Spain
Instituto de Biologia y Genetica Molecular
Valladolid, Spain, 47003
Sponsors and Collaborators
Red de Terapia Celular
Sanidad de Castilla y León
University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Citospin
Investigators
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Principal Investigator: Luis M Redondo, MD, PhD Oral and Maxillofacial Surgeon, Río Hortega University Hospital, SACYL, Valladolid, Spain
Study Director: Ana Sánchez, MD, PhD Instituto de Biología y Genética Molecular (IBGM), University of Valladolid, Spain
Study Director: Javier García-Sancho, MD, PhD University of Valladolid, Spain
Study Director: Jose Becerra, PhD Centro Andaluz de Nanomedicina y Biotecnología (BIONAND), Universidad de Málaga, Ciber-bbn. Málaga, Spain.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT01389661    
Other Study ID Numbers: TerCel0002
2010-024246-30 ( EudraCT Number )
EC10-255 ( Other Grant/Funding Number: Spanish Ministry of Health, Programa de Terapias Avanzadas )
BIOMAX-VA-2010 ( Registry Identifier: Protocol Code )
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Keywords provided by Red de Terapia Celular:
Maxillary bone cysts
Cell therapy
Mesenchymal stem cells
Autologous serum scaffold
Additional relevant MeSH terms:
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Cysts
Bone Cysts
Neoplasms
 Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases