Clinical trials: Lumbar
Cervical Disc Disorder With Radiculopathy, Spinal Stenosis
Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion
The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion…
- Conditions
- Cervical Disc Disorder With Radiculopathy, Spinal Stenosis, Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, Biomechanical Lesion, Unspecified
- Trial name
- NCT06365307
- Testing
- Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft"), Synthetic osteoplastic material based on β-TCP or bone autograft
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Histograft Co., Ltd.
Back Pain, Chronic Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and…
- Conditions
- Back Pain, Chronic Low Back Pain, Internal Disc Disruption, Degenerative Disc Disease
- Trial name
- NCT01011816
- Testing
- BIOSTAT BIOLOGX, Saline
- Where
- 20 sites in United States
- Volunteers
- 220 people
- Sponsor
- Spinal Restoration, Inc.
Intervertebral Disc Disease
Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous…
- Trial name
- NCT01513694
- Testing
- Instrumented posterolateral arthrodesis
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Red de Terapia Celular
Degenerative Disc Disease, Intervertebral Disc Disease
Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease (DDD).
- Conditions
- Degenerative Disc Disease, Intervertebral Disc Disease, Low Back Pain
- Trial name
- Disc_allo (NCT01860417)
- Testing
- Allogenic Mesenchymal Stromal Cells, Mepivacaine
- Where
- 2 sites in Spain
- Volunteers
- 24 people
- Sponsor
- Red de Terapia Celular
Single Level Posterolateral Spinal Fusion
Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion
The hypothesis is that Aastrom TRC autologous bone marrow tissue "grafts" can be safely used to promote bone healing as part of a single level posterolateral spine fusion surgical procedure.
- Trial name
- NCT00797550
- Testing
- Bone Repair Cells (BRCs), Autologous bone graft
- Volunteers
- 2 people
- Sponsor
- Vericel Corporation
Degenerative Lumbar Spondylolisthesis
OP-1 Putty for Posterolateral Fusions
The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.
- Trial name
- NCT00677950
- Testing
- Spinal fusion
- Where
- 24 sites in United States, Canada
- Volunteers
- 336 people
- Sponsor
- Olympus Biotech Corporation
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive
Lumbar Disc Herniation
STA363 in the Treatment of Lumbar Disc Herniation
The goal of this clinical trial is to establish safety and tolerability of STA363 injected into a herniated intervertebral disc in patients with sciatica due to disc herniation. The main questions the trial aims to answer are: 1.
- Trial name
- NCT06022263
- Testing
- Lactic Acid
- Where
- Poland
- Volunteers
- 25 people
- Sponsor
- Stayble Therapeutics
Lumbar Puncture
The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
The investigation aims to demonstrate the first puncture success rate, as proxy of clinical benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance method among pediatric hemato-oncology…
- Trial name
- IQ-LP-03 (NCT04070144)
- Testing
- IQ-Tip(tm) system
- Where
- 3 sites in Finland
- Volunteers
- 50 people
- Sponsor
- Injeq Ltd
Degenerative Disc Disease
Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain
The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back…
- Trial name
- NCT01290367
- Testing
- Single Dose MPCs Injection, Single injection of saline solution, Single injection of hyaluronic acid
- Where
- 14 sites in United States, Australia
- Volunteers
- 100 people
- Sponsor
- Mesoblast, Ltd.
Degenerative Disc Disease, Chronic Low-back Pain
Safety Study for An Artificial Disc Nucleus Replacement to Treat Chronic Low Back Pain
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
- Trial name
- NCT04004156
- Testing
- PerQdisc® Nucleus Replacement Device.
- Where
- 4 sites in Belgium, Canada and 2 more
- Volunteers
- 9 people
- Sponsor
- Spinal Stabilization Technologies
Early Lumbar Disc Degeneration
A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
- Trial name
- NCT01182337
- Testing
- Intradiscal rhGDF-5, Vehicle control
- Where
- 7 sites in South Korea
- Volunteers
- 31 people
- Sponsor
- DePuy Spine
Degenerative Disc Disease, Spinal Stenosis Lumbar
Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)
This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF).
- Conditions
- Degenerative Disc Disease, Spinal Stenosis Lumbar, Lumbar Spine Fusion, Spondylolisthesis
- Trial name
- NCT07775729
- Testing
- Allograft-derived growth factor (ProteiOS®), Standard of Care (SOC)
- Volunteers
- 280 people
- Sponsor
- Isto Biologics
Lumbar Spinal Stenosis
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.
- Trial name
- MiDAS I (NCT00956631)
- Testing
- Interlaminar Decompression
- Where
- 13 sites in United States
- Volunteers
- 78 people
- Sponsor
- Vertos Medical, Inc.
Lumbosacral Radicular Pain
Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2
This is a research study of SP-102, an experimental medication designed to relieve pain in patients with moderate to severe sciatica (pain in the lower back, hips, buttocks and legs).
- Trial name
- CLEAR 2 (NCT07579351)
- Testing
- SP-102, Dexamethasone Sodium Phosphate 10 MG/ML
- Volunteers
- 755 people
- Sponsor
- Semnur Pharmaceuticals, Inc.
Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1
Pedicle Osteotomy for Stenosis Trial
This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar…
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis, Grade 1, Neurogenic Claudication
- Trial name
- POST (NCT03381677)
- Testing
- Pedicle Lengthening Osteotomy with Altum® Device, Control
- Where
- United States
- Volunteers
- 344 people
- Sponsor
- Innovative Surgical Designs
Degenerative Disc Disease (DDD)
HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
- Trial name
- HYDRAFIL-D (NCT06011551)
- Testing
- The ReGelTec HYDRAFIL™ System, Conservative Care Management
- Where
- 16 sites in United States, Canada
- Volunteers
- 225 people
- Sponsor
- ReGelTec, Inc.
Pain, Intractable, Pain, Chronic
Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic…
- Trial name
- NCT06442410
- Testing
- DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system, Conventional Medical Management (CMM)
- Where
- 12 sites in Belgium, Germany and 2 more
- Volunteers
- 115 people
- Sponsor
- MedtronicNeuro
Degenerative Disc Disease
INDEPENDENCE Spacer for Lumbar Fusion
The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and…
- Trial name
- NCT02299323
- Testing
- INDEPENDENCE
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Globus Medical Inc
Degenerative Disc Disease
A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
The objectives of the study are to evaluate the safety and preliminary efficacy of a single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease.
- Trial name
- NCT05574543
- Testing
- AGA111
- Where
- 6 sites in China
- Volunteers
- 60 people
- Sponsor
- Angitia Biopharmaceuticals