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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

Tracking Information
First Submitted Date  ICMJE July 5, 2011
First Posted Date  ICMJE July 8, 2011
Last Update Posted Date April 27, 2017
Actual Study Start Date  ICMJE April 2011
Actual Primary Completion Date April 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment Of Maxillary Bone Cysts With Autologous Bone Mesenchymal Stem Cells (MSV-H)
Official Title  ICMJE Regeneration of Maxillary Bone Cystic Cavities by Bio Implant of MSHV-H Cells Associated to a Cross-linked Serum Scaffold
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Maxillary Cyst
  • Bone Loss of Substance
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Biological: MSV treatment
Publications * Redondo LM, García V, Peral B, Verrier A, Becerra J, Sánchez A, García-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2017)
11
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2011)
10
Actual Study Completion Date  ICMJE April 25, 2016
Actual Primary Completion Date April 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01389661
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Red de Terapia Celular
Original Responsible Party Luis Miguel Redondo, MD, PhD, Principal Investigator, Hospital Universitario Río Hortega, Valladolid
Current Study Sponsor  ICMJE Red de Terapia Celular
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Sanidad de Castilla y León
  • University of Valladolid
  • Centro en Red de Medicina Regenerativa de Castilla y Leon
  • Citospin
Investigators  ICMJE
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.
PRS Account Red de Terapia Celular
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP