Clinical trials: Degenerative Lumbar Spinal Conditions
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.
Disc Degenerative Disease, Back Pain
Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration
The goal of this clinical trial is to find out if a new medicine can help people who have long-lasting back pain caused by damaged spinal discs. The study will also check if the medicine is safe to use.
- Trial name
- CBT005 (NCT07668466)
- Testing
- High Dose, Low Dose
- Where
- Australia
- Volunteers
- 60 people
- Sponsor
- Cartago Biotech Pty Ltd
Chronic Back Pain, Degenerative Disc Disease Lumbar
CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.
- Trial name
- ADAPT (NCT07137559)
- Testing
- CELZ-201-DDT
- Sponsor
- Creative Medical Technology Holdings Inc
Degenerative Spinal Conditions
NeuroVision® Dynamic Screw Test Study
The purpose of this research study is to gather information about the NeuroVision System (which is FDA cleared for this indication) during the placement of pedicle screws.
- Trial name
- NCT01232517
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- NuVasive
Stenosis, Spondylolisthesis
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae)…
- Conditions
- Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT00254852
- Testing
- Posterior Lateral Fusion (PLF), Anterior Lumbar Interbody Fusion (ALIF), Transforaminal lumbar interbody fusion (TLIF)
- Where
- 6 sites in United States
- Volunteers
- 94 people
- Sponsor
- Exactech
Degenerative Changes, Stenosis
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared…
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT01873586
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- SeaSpine, Inc.
Spinal Lumbar Stenosis, Claudication, Intermittent
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
- Trial name
- LB2CT01 (NCT05587465)
- Testing
- Lobster Device
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Diametros Medical srl
Degenerative Disc Disease, Spondylolisthesis
MLX/XLX ACR Expandable Lumbar Interbody Implants
The objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported complications, radiographic outcomes, and clinical…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT04420143
- Where
- 4 sites in United States
- Volunteers
- 109 people
- Sponsor
- NuVasive
Degenerative Disc Disease
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and two controls (saline, Sodium Hyaluronate vehicle) in…
- Trial name
- NCT03347708
- Testing
- IDCT, Saline Solution, Sodium Hyaluronate
- Where
- 14 sites in United States
- Volunteers
- 60 people
- Sponsor
- DiscGenics, Inc.
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft…
- Conditions
- Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis, Spondylolisthesis
- Trial name
- STABILITY (NCT06355791)
- Testing
- Minuteman G5 Device
- Where
- 6 sites in United States
- Volunteers
- 150 people
- Sponsor
- Spinal Simplicity LLC
Low Back Pain
Wallis Stabilization System for Low Back Pain
The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar…
- Trial name
- NCT00484458
- Testing
- Interspinous process and dynamic stabilization (Wallis System), Total Disc Replacement
- Where
- 11 sites in United States
- Volunteers
- 340 people
- Sponsor
- Zimmer Spine
Degenerative Disc Disease
A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.
- Trial name
- NCT01771471
- Testing
- NuQu
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- ISTO Technologies, Inc.
Degenerative Disc Disease, Scoliosis
OLIF25™ /OLIF51™ Study
The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the…
- Trial name
- NCT02657421
- Testing
- Oblique Lateral Interbody Fusion
- Where
- 12 sites in United States, Belgium and 5 more
- Volunteers
- 168 people
- Sponsor
- Medtronic Spinal and Biologics
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
Degenerative Changes, Stenosis
Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT02018445
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- SeaSpine, Inc.
Degenerative Disc Disease, Chronic Low-back Pain
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.
- Trial name
- LOPAIN2 (NCT05508360)
- Testing
- PerQdisc Nucleus Replacement System
- Where
- 11 sites in Colombia, Costa Rica and 3 more
- Volunteers
- 72 people
- Sponsor
- Spinal Stabilization Technologies
Degenerative Disc Disease
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in…
- Trial name
- MSB-DR003 (NCT02412735)
- Testing
- Rexlemestrocel-L, Rexlemestrocel-L + HA Mixture
- Where
- 48 sites in United States, Australia
- Volunteers
- 404 people
- Sponsor
- Mesoblast, Ltd.
Lumbar Degenerative Disc Disease
TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.
- Trial name
- NCT01198470
- Testing
- TRIUMPH® Lumbar Artificial Disc
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Globus Medical Inc
Degenerative Disc Disease, Back Pain
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels.
- Trial name
- NCT00948532
- Testing
- biologic, Osteocel Plus
- Where
- 13 sites in United States
- Volunteers
- 104 people
- Sponsor
- NuVasive
Lumbar Spine Degeneration
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical…
- Trial name
- TLIF (NCT01415908)
- Testing
- INFUSE Bone Graft, Iliac Crest Bone Graft
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Medtronic Spinal and Biologics