Bone CystsNCT03076138
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration
A study testing Gene-activated matrix (OCP + plasmid DNA with VEGF gene) in people with Bone Cysts and Bone Atrophy, run by Histograft Co., Ltd. at 1 site in Russia.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial growth factor (VEGF) for maxillofacial bone regeneration. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bone Cysts, Bone Atrophy, Bone Deformity
- What is being tested?
- Gene-activated matrix (OCP + plasmid DNA with VEGF gene)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 6 Mar 2017to 14 Dec 2018
- 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 60 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, removal of benign neoplasms and pseudotumors, etc.) or alveolar ridge 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 10Show fewer
- participation in other clinical trials (or administration of study products) within 3 months prior the study;
- conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
- pregnancy or lactation;
- malignancies including post-treatment period (surgical, chemotherapy, radiation therapy both alone and in different combinations) less than 5 years prior the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site
A.I. Moscow State University of Medicine and Dentistry
Moscow, 127473
About this study
Official title: The Clinical Trial of the Safety and Efficacy of the Medical Device "Bone Substitute Based on Octacalcium Phosphate and Biologically Active Nucleic Acids for Bone Tissue Regeneration" (Nucleostim-VEGF)
The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial growth factor (VEGF) for maxillofacial bone regeneration. The patients with congenital and acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.
Read the detailed description
All participants of the study will receive standard treatment according to the medical care standards for diseases and pathological conditions characterized by maxillofacial bone defects and/or alveolar ridge atrophy. Bone grafting procedures as part of the surgical treatment will be performed with the use of investigated medical device. The safety and efficacy of the implanted gene-activated bone substitute will be evaluated by clinical examination, comprehensive laboratory tests, and computer tomography within 6 months after surgery.
- Conditions
- Bone Cysts, Bone Atrophy, Bone Deformity, Bone Fracture, Bone Loss, Tooth Loss
- Being tested
- Gene-activated matrix (OCP + plasmid DNA with VEGF gene)
- Keywords
- Gene-activated matrix, Bone substitute, Bone grafting, Dental implantation, gene therapy, plasmid DNA, VEGF gene, octacalcium phosphate
- Medical subject headings
- Bone Cysts, Fractures, Bone, Bone Diseases, Metabolic, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene-activated matrix (OCP + plasmid DNA with VEGF gene)Device
Bone grafting procedure with investigated medical device
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene) Receives: Device: Gene-activated matrix (OCP + plasmid DNA with VEGF gene) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone tissue formation in the field of gene-activated bone substitute implantation
To determine the quantity of newly formed bone tissue the following morphometric parameters will be measured on CT scan using special tools ("ROI", region of interest, etc.):
- average density (in HU);
- size (length, width, height) and volume.
All together both measurements allow to determine "bone tissue formation" as a value derived from the presence of newly formed bone tissue and its volume correspondence with the quantity of the material implanted.
Measured: 6 months
Secondary outcomes (2)
Adverse Events and Serious Adverse Events
Evaluation of the Adverse Events and Serious Adverse Events frequency
Measured: 6 months
Surgical failure rate
Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start6 Mar 2017
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bone CystsStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Histograft Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Moscow State University of Medicine and Dentistry
- Responsible party
- Sponsor
- Investigators
- Alexey Y. Drobyshev, MD,PhD,Prof., Principal investigator, A.I. Evdokimov Moscow State University of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076138
- Sponsor's protocol ID
- RU-Histograft-20-08-2016
- Status last verified
- May 2019
- First submitted
- 5 Mar 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Detailed results of the study will be published in a specialized peer-reviewed scientific journal with an open access
Publications
Deev RV, Drobyshev AY, Bozo IY, Isaev AA. Ordinary and Activated Bone Grafts: Applied Classification and the Main Features. Biomed Res Int. 2015;2015:365050. doi: 10.1155/2015/365050. Epub 2015 Nov 15.
PubMed 26649300Komlev VS, Barinov SM, Bozo II, Deev RV, Eremin II, Fedotov AY, Gurin AN, Khromova NV, Kopnin PB, Kuvshinova EA, Mamonov VE, Rybko VA, Sergeeva NS, Teterina AY, Zorin VL. Bioceramics composed of octacalcium phosphate demonstrate enhanced biological behavior. ACS Appl Mater Interfaces. 2014 Oct 8;6(19):16610-20. doi: 10.1021/am502583p. Epub 2014 Sep 16.
PubMed 25184694Komlev VS, Popov VK, Mironov AV, Fedotov AY, Teterina AY, Smirnov IV, Bozo IY, Rybko VA, Deev RV. 3D Printing of Octacalcium Phosphate Bone Substitutes. Front Bioeng Biotechnol. 2015 Jun 8;3:81. doi: 10.3389/fbioe.2015.00081. eCollection 2015.
PubMed 26106596Deev R, Plaksa I, Bozo I, Isaev A. Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease. Am J Cardiovasc Drugs. 2017 Jun;17(3):235-242. doi: 10.1007/s40256-016-0210-3.
PubMed 28050885Deev RV, Bozo IY, Mzhavanadze ND, Voronov DA, Gavrilenko AV, Chervyakov YV, Staroverov IN, Kalinin RE, Shvalb PG, Isaev AA. pCMV-vegf165 Intramuscular Gene Transfer is an Effective Method of Treatment for Patients With Chronic Lower Limb Ischemia. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):473-82. doi: 10.1177/1074248415574336. Epub 2015 Mar 13.
PubMed 25770117
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Trial of the Safety and Efficacy of the Medical Device "Bone Substitute Based on Octacalcium Phosphate and Biologically Active Nucleic Acids for Bone Tissue Regeneration" (Nucleostim-VEGF)
- ClinicalTrials.gov ID
- NCT03076138
- Acronym / sponsor ID
- RU-Histograft-20-08-2016
- Conditions
- Bone Cysts, Bone Atrophy, Bone Deformity, Bone Fracture, Bone Loss, Tooth Loss
- Keywords
- Gene-activated matrix, Bone substitute, Bone grafting, Dental implantation, gene therapy, plasmid DNA, VEGF gene, octacalcium phosphate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Histograft Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Moscow State University of Medicine and Dentistry
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 10 Mar 2017 (actual)
- 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 the safety and efficacy of the gene-activated bone substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial growth factor (VEGF) for maxillofacial bone regeneration. The patients with congenital and acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.
Detailed description
All participants of the study will receive standard treatment according to the medical care standards for diseases and pathological conditions characterized by maxillofacial bone defects and/or alveolar ridge atrophy. Bone grafting procedures as part of the surgical treatment will be performed with the use of investigated medical device. The safety and efficacy of the implanted gene-activated bone substitute will be evaluated by clinical examination, comprehensive laboratory tests, and computer tomography within 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Gene-activated matrix (OCP + plasmid DNA with VEGF gene)Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene) |
Who may qualify
- Ages
- 18 to 60 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, removal of benign neoplasms and pseudotumors, etc.) or alveolar ridge atrophy.
Key exclusion criteria (10 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 (OCP + plasmid DNA with VEGF gene)Bone grafting procedure with investigated medical device | Device | Test group |
Primary outcome
Bone tissue formation in the field of gene-activated bone substitute implantation
Time frame: 6 months
To determine the quantity of newly formed bone tissue the following morphometric parameters will be measured on CT scan using special tools ("ROI", region of interest, etc.): * average density (in HU); * size (length, width, height) and volume. All together both measurements allow to determine "bone tissue formation" as a value derived from the presence of newly formed bone tissue and its volume correspondence with the quantity of the material implanted.
2 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: 6 months
Surgical failure rate
Time frame: 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 7 May 2019.
- Background: PubMed 26649300Deev RV, Drobyshev AY, Bozo IY, Isaev AA. Ordinary and Activated Bone Grafts: Applied Classification and the Main Features. Biomed Res Int. 2015;2015:365050. doi: 10.1155/2015/365050. Epub 2015 Nov 15.
- Background: PubMed 25184694Komlev VS, Barinov SM, Bozo II, Deev RV, Eremin II, Fedotov AY, Gurin AN, Khromova NV, Kopnin PB, Kuvshinova EA, Mamonov VE, Rybko VA, Sergeeva NS, Teterina AY, Zorin VL. Bioceramics composed of octacalcium phosphate demonstrate enhanced biological behavior. ACS Appl Mater Interfaces. 2014 Oct 8;6(19):16610-20. doi: 10.1021/am502583p. Epub 2014 Sep 16.
- Background: PubMed 26106596Komlev VS, Popov VK, Mironov AV, Fedotov AY, Teterina AY, Smirnov IV, Bozo IY, Rybko VA, Deev RV. 3D Printing of Octacalcium Phosphate Bone Substitutes. Front Bioeng Biotechnol. 2015 Jun 8;3:81. doi: 10.3389/fbioe.2015.00081. eCollection 2015.
- Background: PubMed 28050885Deev R, Plaksa I, Bozo I, Isaev A. Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease. Am J Cardiovasc Drugs. 2017 Jun;17(3):235-242. doi: 10.1007/s40256-016-0210-3.
- Background: PubMed 25770117Deev RV, Bozo IY, Mzhavanadze ND, Voronov DA, Gavrilenko AV, Chervyakov YV, Staroverov IN, Kalinin RE, Shvalb PG, Isaev AA. pCMV-vegf165 Intramuscular Gene Transfer is an Effective Method of Treatment for Patients With Chronic Lower Limb Ischemia. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):473-82. doi: 10.1177/1074248415574336. Epub 2015 Mar 13.
- Individual participant dataSharing planned: Yes. Detailed results of the study will be published in a specialized peer-reviewed scientific journal with an open access
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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.
Alexey Y. Drobyshev, MD,PhD,Prof. principal investigator
A.I. Evdokimov Moscow State University of Medicine and Dentistry
1 site 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 (OCP + plasmid DNA with VEGF gene) in people with Bone Cysts and Bone Atrophy, run by Histograft Co., Ltd. at 1 site 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 10 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Bone tissue formation in the field of gene-activated bone substitute implantation (time frame: 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 NCT03076138, which also lists 5 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 May 2019.