Symptoms and General Pathology

All Conditions

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Neoplasms

Musculoskeletal Diseases

Mouth and Tooth Diseases

Atrophy

Congenital Abnormalities

Fractures, Bone

Cysts

Bone Cysts

Tooth Loss

Periodontal Diseases

Mouth Diseases

Stomatognathic Diseases

Tooth Diseases

Bone Diseases

Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene)

Bone grafting procedure with investigated medical device

Gene-activated matrix (OCP + plasmid DNA with VEGF gene)

Alexey Y. Drobyshev, MD,PhD,Prof.

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.

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.

Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

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)

Detailed results of the study will be published in a specialized peer-reviewed scientific journal with an open access

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.

Evaluation of the Adverse Events and Serious Adverse Events frequency

Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute

Moscow State University of Medicine and Dentistry

Histograft Co., Ltd.

Rare Diseases

Bone Cysts, Aneurysmal

Pathological Conditions, Anatomical

Aneurysmal Bone Cysts

Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel® will be included.

Analysis datas of medical record.

Analysis datas of medical record:

* Feasibility of the technique
* Safety of the technique
* Efficacity (sclerose of the lesion)

datas of medical record.

Sylvain Grange, MD

Valentin Gineys, resident

There is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. Some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: Ethibloc no longer marketed, pure Ethanol, Aetoxisclerol.

The aim of this work is therefore the evaluation of Discogel® in the treatment of Discogel®, which appears to be a safe and efficacity of method.

Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts

Collect from medical records the number of procedures that were completed and performed as theoretically intended.

Centre Hospitalier Universitaire de Saint Etienne

I-040302 doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34

Standard of care (bone marrow aspirate or steroids)

doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34

I-040302

Standard of Care

Virginia Jamieson, MD

This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance imaging (MRI) in the diagnosis of a solitary bone cyst.

Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts

A Phase 2 Randomised, Open-label, Multi-centre Ascending Dose Study of the Efficacy, Safety and Tolerability of I-040302 Versus Control Injection (Bone Marrow Aspirate or Steroids) in Children and Young Adults With Solitary Bone Cysts

Kuros Biosurgery AG

20 bone cysts (in 20 patients) are filled with bioactive glass

20 bone cysts (in 20 patients) are filled with allogenic bone

Comparison of bioactive glass to allogenic bone in pediatric bone cysts

Bioactive glass

Johanna Syvänen, PhD

Ilkka Helenius, Prof

Yrjänä Nietosvaara, PhD

Jenni Jalkanen, Phd

Juha-Jaakko Sinikumpu, Prof

Anne Salonen, PhD

The Finnish Paediatric Orthopedic Study Group will perform a prospective, randomized, multicenter, clinical trial comparing two bone substitutes (allograft and bioactive glass, BonAlive®) in treating bone cysts in children (18 years or younger). The trial is carried out in five University Hospitals (Turku, Helsinki, Tampere, Oulu, Kuopio) in Finland.

Twenty patients will be randomized into each group. In all University Hospitals the treatment protocol will be same. Randomization will be performed using a sealed envelope technique.

Before surgery all patients will be examined clinically. After conventional radiographs all patients will be examined with magnetic resonance imaging showing cyst's size, anatomy, location and adjacent structures.

If the aneurysmal bone cyst is large or in difficult location, embolization by the radiologist can be used preoperatively.

Surgical technique:

Surgery will be done by experienced paediatric orthopaedic surgeons. Normal orthopaedic exposures will be used. The cyst is opened so that square window is done to the cortex. A sample to the pathologist is collected, also intraoperative frozen section is used to confirm the diagnosis. A mechanical curettage with use of a curette and a high speed burr is used to inspect the whole cavity. The tumour is resected as thoroughly as possible. After curettage 5% phenol is inserted to the cavity and it is neutralized with saline. Cyst volume is evaluated using saline (ml). Then the cyst is filled with morsellized femoral head allograft or bioactive glass (BG-S53P4) according to randomization. The biggest granule size 2-3,15mm is used for femur, tibia, pelvis and humerus. If the cyst volume is below 10ml in these places then smaller granule size (1-2mm) is chosen. If the cyst is in hand region then the granule size is 0,5-0,8mm. At the end of the operation the window's roof is inserted back. All the time X-ray is used to ensure that the whole cyst is treated properly. Osteosynthesis will be performed whenever it is necessary to prevent a pathological fracture.

After surgery the diagnosis will be confirmed histopathologically.

All patients will receive standard anesthesia.

Postoperatively an X-ray will be taken. Radiographic controls after surgery will be held at 1 Mo, 3 Mo, 6Mo, 12Mo and 24Mo. Three months control and two years control will be accompanied with MRI.

If the cyst is found after a pathologic fracture, the fracture is healed first with the cast +/- traction and MRI will be taken before surgery.

Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts

A Randomized Clinical Trial Comparing Curettage With Allogenic Bone Grafting and Curettage With Bioactive Glass Filling in Children With Bone Cysts CYSTS

Enneking's grading system (scale 1-3, 1=latent, 2=active, 3=aggressive)

Musculoskeletal society tumor score (scale 0-5, 5=best outcome, 0=worst outcome)

Fracture after operation at the filled area in radiograph (yes / no)

Bonalive Biomaterials Ltd

Turku University Hospital

Patient aging from 0 to 30 years with diagnosis of aneurysmal bone cyst treated by percutaneous alcolisation or endovascular embolization.

Interventional radiology for aneurysmal bone cyst ( percutaneous alcoholization, vascualr embolisation)

radiology

Catherine CYTEVAL, MD.PhD

This study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization)

Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment

Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment: Clinical and Radiological Outcome

Percentage of peripheral reossification after treatment :

* 0%: no reossification
* \< 25%: low reossification
* Between 25% -50%: Partial reossification
* Between 50-75%: significant reossification
* \> 75%: very significant reossification
* 100%: complete reossifcation

Pain measured with Pain scale ( 0 = no pain , 10 = maximum pain)

Number of patients needs second treatment 3- Fracture ? (yes or no)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.
Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts	NCT05880628	Bone Cysts	datas of medica...	-	Centre Hospitalier Universitaire de Saint Etienne
Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts	NCT00459641	Bone Cysts	I-040302 Standard of Car...	6 Years - 16 Years	Kuros Biosurgery AG
Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts	NCT04737590	Bone Cysts	Bioactive glass	1 Year - 18 Years	Turku University Hospital
Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts	NCT04737590	Bone Cysts	Bioactive glass	1 Year - 18 Years	Turku University Hospital
Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment	NCT05075148	Bone Cysts	radiology	0 Years -	University Hospital, Montpellier
Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment	NCT05075148	Bone Cysts	radiology	0 Years -	University Hospital, Montpellier
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.
Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts	NCT05880628	Bone Cysts	datas of medica...	-	Centre Hospitalier Universitaire de Saint Etienne

Spots Global Cancer Trial Database for bone cysts

Every month we try and update this database with for bone cysts cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bone cysts

Every month we try and update this database with for bone cysts cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bone cysts cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.