Symptoms and General Pathology

All Conditions

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Musculoskeletal Diseases

Mouth and Tooth Diseases

Neoplasms

Nervous System Diseases

Atrophy

Congenital Abnormalities

Fractures, Bone

Alveolar Bone Loss

Bone Neoplasms

Tooth Diseases

Jaw Fractures

Pathological Conditions, Anatomical

Bone Diseases

Bone Resorption

Periodontal Atrophy

Periodontal Diseases

Mouth Diseases

Stomatognathic Diseases

Maxillofacial Injuries

Facies

Facial Injuries

Craniocerebral Trauma

Trauma, Nervous System

Skull Fractures

Implantation of gene-activated matrix "Nucleostim" into the bone defects or sites of bone atrophy

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"®.

Gene-activated matrix "Nucleostim"

Alexey Yu Drobyshev, MD, PhD, DSc

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.

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.

Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration

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.

Level of edema at the surgical site will be assessed by physician using 0-10 Numeric Rating Scale.

Burnasyan Federal Medical Biophysical Center

Moscow State University of Medicine and Dentistry

NextGen Company Limited

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

Aqueous solution of plasmid DNA administered by intramuscular injection using the TDS-IM electroporation device (Ichor Medical Systems, Inc.) at week 0, 3, 6, 12 and 24. Part 1 of the study will escalate through 0.4, 2.0, 4.0 and 8.0 mg dose level cohorts, each of three patients. In Part 2 of the study the 4.0 and 8.0 mg doses will be administered in the same regimen. At the discretion of the investigator, patients in both parts of the study may continue to receive SCIB1 at 3-6 month intervals for 5 years.

SCIB1

Poulam M Patel, MD

Paul Lorigan, MD

Maria Marples, MD

Christian Ottensmeier, MD

Hardev Pandha, MD

The study is an investigation of a novel immunotherapy, SCIB1, for the treatment of melanoma. SCIB1 is a solution of plasmid DNA molecules which will express a modified antibody in human cells. The antibody modifications are designed to stimulate the patient's immune T cells to have a strong and specific reaction against melanoma cells which should then be eliminated. SCIB1 is injected into muscle using a device which simultaneously delivers an electrical impulse to enhance the transfer of SCIB1 into muscle cells. The trial will assess the safety and tolerability of SCIB1, the safety and performance of the injection device and the immunological effects of SCIB1. This is the first study of SCIB1 in humans and the trial has two parts, in the first part the dose will be escalated to determine a safe and tolerable level up to a maximum of 8 mg per dose. In the second part patients will receive the dose determined in the first part. Patients will have stage III or IV melanoma, be HLA type A2 and have a life expectancy of at least three months. All patients will receive 5 injections of SCIB1 over 5.5 months. At the discretion of the investigator, patients may continue to receive SCIB1 at 3-6 month intervals for 5 years. The study will be conducted at major cancer centres in the UK only and is expected to last for seven years. Patients will be followed up for five years after they have completed the trial.

Study of a DNA Immunotherapy to Treat Melanoma

A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma

Recording and assessment of adverse events to establish safety and tolerability of an investigational immunotherapy, SCIB1, in patients with melanoma whose cancer has spread from the initial tumour (i.e., stage III or stage IV melanoma).

(i) Recording and assessment of adverse events and patient recorded experience to establish safety and tolerability of SCIB1 administered intramuscularly to melanoma patients using the TDS IM device.

(ii) Cellular immune response by ex vivo assay induced by SCIB1 administered intramuscularly to melanoma patients using the TDS-IM device.

(iii) Tumour response by CT scan in patients treated with SCIB1 (Part One only).

Scancell Ltd

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery	NCT02293031	Maxillofacial B... Alveolar Bone A... Jaw Fractures Maxillofacial B... Bone Neoplasm, ... Disorders of Te...	Gene-activated ...	18 Years - 55 Years	NextGen Company Limited
Study of a DNA Immunotherapy to Treat Melanoma	NCT01138410	Malignant Melan...	SCIB1	18 Years -	Scancell Ltd

Spots Global Cancer Trial Database for dna plasmid

Every month we try and update this database with for dna plasmid 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 dna plasmid

Every month we try and update this database with for dna plasmid 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 dna plasmid 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.