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
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|Condition or disease||Intervention/treatment||Phase|
|Maxillary Cyst Bone Loss of Substance||Biological: MSV treatment||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|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)|
|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|
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
- 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.
- 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.
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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|
- 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
- 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
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
|Río Hortega University Hospital|
|Valladolid, Valladid, Spain, 47012|
|Bionand, Parque Tecnológico de Andalucía, Universidad de Málaga|
|Instituto de Biologia y Genetica Molecular|
|Valladolid, Spain, 47003|
|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.|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Red de Terapia Celular|
|Other Study ID Numbers:||
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|
Maxillary bone cysts
Mesenchymal stem cells
Autologous serum scaffold
Pathological Conditions, Anatomical