Maxillary CystPhase 1/2BIOMAXNCT01389661
Treatment Of Maxillary Bone Cysts With Autologous Bone Mesenchymal Stem Cells (MSV-H)
A Phase 1/2 study testing MSV treatment in people with Maxillary Cyst and Bone Loss of Substance, run by Red de Terapia Celular at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Maxillary Cyst, Bone Loss of Substance
- What is being tested?
- MSV treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesSpain
- Study dates
- Apr 2011to 25 Apr 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Bionand, Parque Tecnológico de Andalucía, Universidad de Málaga
Málaga
Río Hortega University Hospital
Valladolid, Valladid, 47012
Instituto de Biologia y Genetica Molecular
Valladolid, 47003
About this study
Official title: Regeneration of Maxillary Bone Cystic Cavities by Bio Implant of MSHV-H Cells Associated to a Cross-linked Serum Scaffold
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.
Read the 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.
- Conditions
- Maxillary Cyst, Bone Loss of Substance
- Being tested
- MSV treatment
- Keywords
- Maxillary bone cysts, Cell therapy, Mesenchymal stem cells, Autologous serum scaffold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSV treatmentBiological
Also called H-MSV, Human Mesenchymal Stem Cells from Valladolid
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)
| Study group | Role | What they receive |
|---|---|---|
| MSV treatment | Experimental | 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 Receives: Biological: MSV treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility and safety of the implementation of MSV in the treatment of maxillary cysts
Clinical review and orthopantomograpy at different periods (0, 2 weeks, 2 months and 6 months) assessing evolution from baseline and possible complications.
Measured: up to 6 months
Secondary outcomes (1)
Indication of efficacy
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startApr 2011
- Primary completion25 Apr 2016
- Study completion25 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Red de Terapia Celular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanidad de Castilla y León, University of Valladolid, Centro en Red de Medicina Regenerativa de Castilla y Leon, Citospin
- Responsible party
- Sponsor
- Investigators
- Luis M Redondo, MD, PhD, Principal investigator, Oral and Maxillofacial Surgeon, Río Hortega University Hospital, SACYL, Valladolid, SpainAna Sánchez, MD, PhD, Study director, Instituto de Biología y Genética Molecular (IBGM), University of Valladolid, SpainJavier García-Sancho, MD, PhD, Study director, University of Valladolid, SpainJose Becerra, PhD, Study director, Centro Andaluz de Nanomedicina y Biotecnología (BIONAND), Universidad de Málaga, Ciber-bbn. Málaga, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389661
- Sponsor's protocol ID
- TerCel0002
- Other IDs
- 2010-024246-30, EC10-255, BIOMAX-VA-2010
- Acronym
- BIOMAX
- Status last verified
- Apr 2017
- First submitted
- 5 Jul 2011
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Redondo LM, Garcia V, Peral B, Verrier A, Becerra J, Sanchez A, Garcia-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.
PubMed 29229365
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regeneration of Maxillary Bone Cystic Cavities by Bio Implant of MSHV-H Cells Associated to a Cross-linked Serum Scaffold
- ClinicalTrials.gov ID
- NCT01389661
- Acronym / sponsor ID
- BIOMAX / TerCel0002
- Conditions
- Maxillary Cyst, Bone Loss of Substance
- Keywords
- Maxillary bone cysts, Cell therapy, Mesenchymal stem cells, Autologous serum scaffold
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Red de Terapia CelularIndustry (pharma, biotech, devices)
- Collaborators
- Sanidad de Castilla y León, University of Valladolid, Centro en Red de Medicina Regenerativa de Castilla y Leon, Citospin
- Study start
- Apr 2011 (actual)
- Primary completion
- 25 Apr 2016 (actual)
- Study completion
- 25 Apr 2016 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| MSV treatment | Experimental | Biological: MSV treatmentMSV 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSV treatmentAlso: H-MSV, Human Mesenchymal Stem Cells from ValladolidAutologous 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) | Biological | MSV treatment |
Primary outcome
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.
1 secondary outcome
Indication of efficacy
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Derived from this study: PubMed 29229365Redondo LM, Garcia V, Peral B, Verrier A, Becerra J, Sanchez A, Garcia-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.
- Cell production, Instituto de Biologia y Genetica Molecular (IBGM) University of ValladolidLink provided by the sponsor.
- Diseases, Jaw; Jaw DiseaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis M Redondo, MD, PhD principal investigator
Oral and Maxillofacial Surgeon, Río Hortega University Hospital, SACYL, Valladolid, Spain
Ana Sánchez, MD, PhD study director
Instituto de Biología y Genética Molecular (IBGM), University of Valladolid, Spain
Javier García-Sancho, MD, PhD study director
University of Valladolid, Spain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSV treatment in people with Maxillary Cyst and Bone Loss of Substance, run by Red de Terapia Celular at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility and safety of the implementation of MSV in the treatment of maxillary cysts (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.