Maxillofacial Bone DefectsNCT02293031
Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery
A study testing Gene-activated matrix "Nucleostim" in people with Maxillofacial Bone Defects and Alveolar Bone Atrophy, run by NextGen Company Limited at 2 sites in Russia.
Trial summary
The purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("Nucleostim") for regeneration of bone tissue in maxillofacial area. Patients with congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Maxillofacial Bone Defects, Alveolar Bone Atrophy, Jaw Fractures
- What is being tested?
- Gene-activated matrix "Nucleostim"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesRussia
- Study dates
- Nov 2014to Dec 2017
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obtained voluntary informed consent for participation in the clinical study;
- congenital and acquired maxillofacial bone defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy.
Who cannot join
- not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study;
- decompensated chronic visceral diseases;
- clinically significant laboratory abnormalities;
- HIV, HBV and HCV antibodies in serum;
- alcohol consumption within 4 days prior the study;
- history of drug addiction;
Show all 11Show fewer
- participation in other clinical studies (or administration of study products) within 3 months prior the study;
- conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
- malignancies including post-surgical period with chemo- and (or) radiation therapy);
- vascular malformations;
- pregnancy or lactation.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Burnasyan Federal Medical Biophysical Center
Moscow
Moscow State University of Medicine and Dentistry
Moscow
About this study
Official title: Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration
The purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("Nucleostim") for regeneration of bone tissue in maxillofacial area. Patients with congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy will be included into the study.
Read the detailed description
All patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. Maxillofacial bone defects (formed after injuries, surgeries, excision of benign neoplasms and pseudotumors, teeth extraction, etc.) or areas of alveolar bone atrophy will be the filled by gene-activated matrix "Nucleostim". Safety and efficacy of implanted osteoplastic material will be assessed by physical examination, comprehensive laboratory tests, X-ray examination within 60 days after operation.
- Conditions
- Maxillofacial Bone Defects, Alveolar Bone Atrophy, Jaw Fractures, Maxillofacial Bone Deformities, Bone Neoplasm, Benign, Disorders of Teeth and Jaw
- Being tested
- Gene-activated matrix "Nucleostim"
- Keywords
- maxillofacial bone defects, alveolar ridge atrophy, gene-activated matrix, VEGF gene, DNA plasmid, bone gene therapy
- Medical subject headings
- Alveolar Bone Loss, Jaw Fractures, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene-activated matrix "Nucleostim"Device
Gene-activated matrix "Nucleostim" is bone graft substitute consisting of collagen-hydroxyapatite composite scaffold and DNA plasmids with gene encoding vascular endothelial grothw factor (VEGF-A165) in concentration 100-120 ng/mg which is an active substance of gene-therapeutic drug "Neovasculgen"®.
| Study group | Role | What they receive |
|---|---|---|
| Gene-activated matrix "Nucleostim" | Experimental | Implantation of gene-activated matrix "Nucleostim" into the bone defects or sites of bone atrophy Receives: Device: Gene-activated matrix "Nucleostim" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
To determine the quantity of newly-formed bone tissue the morphometric parameters of regenerate will be measured on CT scan using special tools ("ROI", region of interest, etc.)
The morphometric parameters of bone regenerate include:
- average density (in HU);
- size (length, width, height) and volume.
Measured: 60 days
Secondary outcomes (4)
Pain scores on the visual analog scale
Measured: 60 days
Surgical failure rate
Measured: 60 days
Adverse Events
Measured: 60 days
Edema scores on the 0-10 Numeric Rating Scale
Level of edema at the surgical site will be assessed by physician using 0-10 Numeric Rating Scale.
Measured: 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial Bone DefectsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NextGen Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Burnasyan Federal Medical Biophysical Center, Moscow State University of Medicine and Dentistry
- Responsible party
- Sponsor
- Investigators
- Alexey Yu Drobyshev, MD, PhD, DSc, Principal investigator, Moscow State University of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293031
- Sponsor's protocol ID
- RU-NextGen-20-01-2013
- Status last verified
- Mar 2016
- First submitted
- 11 Nov 2014
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bozo I.Y., Deev R.V., Drobyshev A.Y., D. Galetskiy D.V., Isaev A.A. Gene technologies in maxillofacial surgery: development of gene-activated bone grafts. International Journal of Oral and Maxillofacial Surgery 42(10): 1179-1180, 2013
Deev R.V., Drobyshev A.Y., Bozo I.Y., Isaev A.A. Angiogenic non-viral gene transfer: from ischemia treatment to bone defects repair. J Tissue Eng. Regen. Med. 8 (Suppl. 1): 64-65, 2014
Deev RV, Bozo IIa, Mzhavanadze ND, Nersesian EG, Chukhralia OV, Shval'b PG, Cherviakov IuV, Staroverov IN, Kalinin RE, Voronov DA, Gavrilenko AV, Isaev AA. [Efficacy of using VEGF165 gene in comprehensive treatment of patients with stage 2A-3 lower limb chronic ischaemia]. Angiol Sosud Khir. 2014;20(2):38-48. Russian.
PubMed 24961325Bozo IY, Deev RV, Drobyshev AY, Isaev AA, Eremin II. World's First Clinical Case of Gene-Activated Bone Substitute Application. Case Rep Dent. 2016;2016:8648949. doi: 10.1155/2016/8648949. Epub 2016 Nov 7.
PubMed 27891264
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration
- ClinicalTrials.gov ID
- NCT02293031
- Acronym / sponsor ID
- RU-NextGen-20-01-2013
- Conditions
- Maxillofacial Bone Defects, Alveolar Bone Atrophy, Jaw Fractures, Maxillofacial Bone Deformities, Bone Neoplasm, Benign, Disorders of Teeth and Jaw
- Keywords
- maxillofacial bone defects, alveolar ridge atrophy, gene-activated matrix, VEGF gene, DNA plasmid, bone gene therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- NextGen Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Burnasyan Federal Medical Biophysical Center, Moscow State University of Medicine and Dentistry
- Study start
- Nov 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Nov 2014 (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.
The purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("Nucleostim") for regeneration of bone tissue in maxillofacial area. Patients with congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy will be included into the study.
Detailed description
All patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. Maxillofacial bone defects (formed after injuries, surgeries, excision of benign neoplasms and pseudotumors, teeth extraction, etc.) or areas of alveolar bone atrophy will be the filled by gene-activated matrix "Nucleostim". Safety and efficacy of implanted osteoplastic material will be assessed by physical examination, comprehensive laboratory tests, X-ray examination within 60 days after operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gene-activated matrix "Nucleostim" | Experimental | Device: Gene-activated matrix "Nucleostim"Implantation of gene-activated matrix "Nucleostim" into the bone defects or sites of bone atrophy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obtained voluntary informed consent for participation in the clinical study;
- congenital and acquired maxillofacial bone defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy.
Key exclusion criteria (11 listed)
- not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study;
- decompensated chronic visceral diseases;
- clinically significant laboratory abnormalities;
- HIV, HBV and HCV antibodies in serum;
- alcohol consumption within 4 days prior the study;
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 |
|---|---|---|
| Gene-activated matrix "Nucleostim"Gene-activated matrix "Nucleostim" is bone graft substitute consisting of collagen-hydroxyapatite composite scaffold and DNA plasmids with gene encoding vascular endothelial grothw factor (VEGF-A165) in concentration 100-120 ng/mg which is an active substance of gene-therapeutic drug "Neovasculgen"®. | Device | Gene-activated matrix "Nucleostim" |
Primary outcome
Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
Time frame: 60 days
To determine the quantity of newly-formed bone tissue the morphometric parameters of regenerate will be measured on CT scan using special tools ("ROI", region of interest, etc.) The morphometric parameters of bone regenerate include: * average density (in HU); * size (length, width, height) and volume.
4 secondary outcomes
Pain scores on the visual analog scale
Time frame: 60 days
Surgical failure rate
Time frame: 60 days
Adverse Events
Time frame: 60 days
Edema scores on the 0-10 Numeric Rating Scale
Time frame: 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- BackgroundBozo I.Y., Deev R.V., Drobyshev A.Y., D. Galetskiy D.V., Isaev A.A. Gene technologies in maxillofacial surgery: development of gene-activated bone grafts. International Journal of Oral and Maxillofacial Surgery 42(10): 1179-1180, 2013
- BackgroundDeev R.V., Drobyshev A.Y., Bozo I.Y., Isaev A.A. Angiogenic non-viral gene transfer: from ischemia treatment to bone defects repair. J Tissue Eng. Regen. Med. 8 (Suppl. 1): 64-65, 2014
- Background: PubMed 24961325Deev RV, Bozo IIa, Mzhavanadze ND, Nersesian EG, Chukhralia OV, Shval'b PG, Cherviakov IuV, Staroverov IN, Kalinin RE, Voronov DA, Gavrilenko AV, Isaev AA. [Efficacy of using VEGF165 gene in comprehensive treatment of patients with stage 2A-3 lower limb chronic ischaemia]. Angiol Sosud Khir. 2014;20(2):38-48. Russian.
- Results publication: PubMed 27891264Bozo IY, Deev RV, Drobyshev AY, Isaev AA, Eremin II. World's First Clinical Case of Gene-Activated Bone Substitute Application. Case Rep Dent. 2016;2016:8648949. doi: 10.1155/2016/8648949. Epub 2016 Nov 7.
Related trials for Maxillofacial Bone Defects
Recruiting
Bone Marrow Mononuclear Cells for the Repair of Severe Maxillofacial Bone Defects
Maxillofacial Bone Defect, Alveolar Bone Loss
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.
Alexey Yu Drobyshev, MD, PhD, DSc principal investigator
Moscow State University of Medicine and Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gene-activated matrix "Nucleostim" in people with Maxillofacial Bone Defects and Alveolar Bone Atrophy, run by NextGen Company Limited at 2 sites in Russia.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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.
Are results available for this study?
Results are not available in the source record.
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?
Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation (time frame: 60 days). 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 NCT02293031, which also lists 4 linked publications.
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 7 Mar 2017.