Status:
UNKNOWN
Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery
Lead Sponsor:
NextGen Company Limited
Collaborating Sponsors:
Burnasyan Federal Medical Biophysical Center
Moscow State University of Medicine and Dentistry
Conditions:
Maxillofacial Bone Defects
Alveolar Bone Atrophy
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 maxill...
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 inju...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02293031
Start Date
November 1 2014
End Date
December 1 2017
Last Update
March 7 2017
Active Locations (2)
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1
Burnasyan Federal Medical Biophysical Center
Moscow, Russia
2
Moscow State University of Medicine and Dentistry
Moscow, Russia