Clinical trials: Bone Regeneration
Bone Fracture
Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications: 1.
- Trial name
- NCT03024008
- Testing
- BonoFill-II
- Where
- 6 sites in Israel
- Volunteers
- 40 people
- Sponsor
- BonusBio Group Ltd
Ankle and Hindfoot Arthrodesis
Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft
The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft.
- Trial name
- NCT03998137
- Testing
- AUGMENT® Injectable Bone Graft, Standard of Care
- Volunteers
- 94 people
- Sponsor
- BioMimetic Therapeutics
Proximal (Subtrochanteric)Femoral Fractures, Distal Femoral Fractures
Evaluation of the Safety and Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Femoral Fractures
Certain types of fractures require surgical intervention that may involve the use of bone grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer from disadvantages such as soft tissue…
- Trial name
- NCT01687530
- Testing
- AMCA Bone Membrane.
- Where
- 2 sites in Israel
- Volunteers
- 48 people
- Sponsor
- RegeneCure, Ltd.
Myocardial Ischemia, Coronary Artery Disease
Intramyocardial Transplantation of Bone Marrow Stem Cells in Addition to Coronary Artery Bypass Graft (CABG) Surgery
In spite of the fact that the post-myocardial infarction survival rate has improved with recent medical advances, reduced heart function attributed to irreversible loss of viable cardiomyocytes is still a major clinical problem.
- Trial name
- PERFECT (NCT00950274)
- Testing
- CD133+ autologous bone marrow stem cell
- Where
- 6 sites in Germany
- Volunteers
- 81 people
- Sponsor
- Miltenyi Biotec B.V. & Co. KG
Maxillofacial Bone Defects, Alveolar Bone Atrophy
Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery
The purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("Nucleostim") for regeneration of bone tissue in maxillofacial area.
- Conditions
- Maxillofacial Bone Defects, Alveolar Bone Atrophy, Jaw Fractures, Maxillofacial Bone Deformities
- Trial name
- NCT02293031
- Testing
- Gene-activated matrix "Nucleostim"
- Where
- 2 sites in Russia
- Volunteers
- 12 people
- Sponsor
- NextGen Company Limited
Guided Bone Regeneration
RES-SAFE (Resorption, Safety, and Efficacy of Absorbable Collagen Membrane)
The clinical study aims to assess the long-term safety and efficacy of the interventional medical device. The clinical study will enrol up to 50 patients aged 18 years and older, who meet specific inclusion and exclusion criteria…
- Trial name
- NCT06570265
- Testing
- GBR membrane
- Volunteers
- 50 people
- Sponsor
- Hyundai Bioland Co., Ltd.
Alveolar Ridge Defect
CopiOs® Pericardium Membrane for Localized Alveolar Ridge Augmentation
This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane, a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation of localized alveolar ridge defects on…
- Trial name
- NCT00889265
- Testing
- CopiOs Pericardium Membrane
- Where
- 4 sites in United States
- Volunteers
- 51 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Knee, Knee Degenerative Disease
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells
In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence).
- Conditions
- Osteoarthritis, Knee, Knee Degenerative Disease, Knee Osteoarthritis
- Trial name
- KDD&MSV (NCT01183728)
- Testing
- Autologous bone marrow mesenchymal stem cells (MSV)
- Where
- 2 sites in Spain
- Volunteers
- 12 people
- Sponsor
- Red de Terapia Celular
Bone Loss
Comparison of Straumann Bone Ceramic and Bio-Oss With Guided Tissue Regeneration for Alveolar Ridge Preservation
The purpose of this study is to compare a new biomaterial with an already existing treatment principle (Bio-Oss/Bio-Gide) with regard to their ability to preserve the dimensions of the alveolar ridge and to promote bone…
- Trial name
- NCT00900718
- Testing
- Straumann Bone Ceramic, Bio-Oss
- Where
- United Kingdom
- Volunteers
- 27 people
- Sponsor
- Institut Straumann AG
Bone Substitutes
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant
Multi-center, prospective, open-label, single-arm, first-in-human clinical investigation. The patient enrollment will be as follow: initial 5 patients enrolled at PI site.
- Trial name
- GreenBric (NCT03836404)
- Testing
- Iliac crest reconstruction surgery
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- GreenBone Ortho S.p.A.
Ankle and Hindfoot Arthrodesis
Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
The objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft.
- Trial name
- NCT02879149
- Testing
- AUGMENT® Bone Graft, Standard of Care
- Where
- 26 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- BioMimetic Therapeutics
Bone Void in the Maxillofacial Area
Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration
Phase I/II open label first in human single center clinical study, is to evaluate the safety and the efficacy of BonoFill as bone filler containing the patient own (autologous) adipose tissue derived cells (HATDCs) in…
- Trial name
- NCT02153268
- Testing
- Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study
- Where
- Israel
- Volunteers
- 11 people
- Sponsor
- BonusBio Group Ltd
Maxillary Cyst, Bone Loss of Substance
Treatment Of Maxillary Bone Cysts With Autologous Bone Mesenchymal Stem Cells (MSV-H)
This trial pretends to validate for clinical use a bioengineered product composed of MSV cells (mesenchymal stem cells produced by IBGM, Valladolid, which have already been approved by the Spanish Regulatory Agency for three…
- Trial name
- BIOMAX (NCT01389661)
- Testing
- MSV treatment
- Where
- 3 sites in Spain
- Volunteers
- 11 people
- Sponsor
- Red de Terapia Celular
Degenerative Disc Disease
Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain
The objective of this study is to evaluate the safety and efficacy of viable allograft transplantation for the treatment of patients with symptomatic disc degeneration and tissue loss.
- Trial name
- VAST (NCT03709901)
- Testing
- Active Allograft
- Where
- 13 sites in United States
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- VIVEX Biologics, Inc.
Foot Fusion
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone…
- Trial name
- NCT00583375
- Testing
- Augment® Bone Graft, Standard of Care
- Where
- 37 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- BioMimetic Therapeutics
Bone Regeneration, Dental Implants
Creos Xenoprotect PMCF
The goal of this retrospective PMCF study is to assess safety and performance of creos xenoprotect in all indications functioning as dental barrier membrane.
- Conditions
- Bone Regeneration, Dental Implants, Bone Grafting
- Trial name
- NCT07153185
- Testing
- Dental Barrier Membrane
- Volunteers
- 200 people
- Sponsor
- Nobel Biocare
Bone Regeneration
Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
Guided Bone Regeneration (GBR) is a well-established surgical technique that employs barrier membranes to ensure the stability of bone augmentation material while preventing the infiltration of soft tissue, thereby facilitating…
- Trial name
- LyOral (NCT06732167)
- Testing
- GBR Lyoplant, GBR Bio-Gide
- Where
- 2 sites in Spain
- Volunteers
- 68 people
- Sponsor
- Aesculap AG
Degenerative Joint Disease, Congenital Deformity
Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
STUDY OBJECTIVES: To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions) STUDY HYPOTHESIS: Augment® Injectable is an equivalent…
- Conditions
- Degenerative Joint Disease, Congenital Deformity, Arthritis, Osteoarthritis
- Trial name
- NCT01305356
- Testing
- Augment® Injectable Bone Graft, Autologous bone graft
- Where
- 25 sites in United States, Canada
- Volunteers
- 299 people
- Sponsor
- BioMimetic Therapeutics
Guided Bone Regeneration
Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
The goal of this observational study is to measure in real practice the performance and safety of RTR+Membrane, a synthetic dental membrane for guided tissue regeneration in periodontal or dental implant surgery.
- Trial name
- ObsR+ (NCT06467630)
- Testing
- Preserving alveolar bone volume after tooth extraction, Alveolar crest reconstruction, Covering bone defects during immediate implant placement.
- Where
- 9 sites in France
- Volunteers
- 90 people
- Sponsor
- Septodont
Surgery, Oral
Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
The goal of this clinical trial is to compare the maintenance of socket volume in the groups treated by a resorbable regenerative membrane (Plenum® Guide) covered or not with mucous tissue, with control without treatment.
- Trial name
- NCT06015906
- Testing
- Plenum® Guide, Plenum® Oss, Tooth extraction
- Where
- Brazil
- Volunteers
- 150 people
- Sponsor
- M3 Health