CLINICAL TRIALS FOR ORTHOPEDIC PAIN

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MESOBLAST INTRADISCAL (Stem Cell Study for Low Back Pain)

Phase III FDA trial –  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 subjects with chronic discogenic lumbar back pain (>6 months) associated with moderate Degenerative Disc Disease (DDD).

Mesoblast has developed a proprietary mesenchymal lineage adult Stem Cell (MLC).   These Stem Cells are found in multiple tissues where they play a vital role in maintaining tissue health.

Stem Cells have been found to secrete biomolecules involved in enhanced migration and proliferation of intervertebral disc progenitor cells, and in enhanced proteoglycan and collagen synthesis in the disc nucleus and annulus. These biomolecules include Angiopoietin-1 and transforming growth factor beta.

JOINTSTEM STUDY (Stem Cell Study for Knee Pain)

Phase II, double-blind, randomized, controlled study with two arms to evaluate JointStem (an autologous stem cell line derived from your own fat tissue) as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 45 subjects will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 positive control). After the last subject completes 6-month visit (Visit 6) and the data management team confirms all data have no issue, the database will be locked and the blinding will be open for the statistical analysis. Subjects will then be scheduled for 9-month and 12-month follow-up visits (Visits 7 and 8).

Adipose (fat tissue) is harvested from the abdomen by liposuction.  The adipose tissue is then processed to isolate stem cells.  The stem cells are then expanded in a sterile lab setting over a number of days to create the Investigational Drug.  The subjects are then randomized for knee injection between the Investigational Drug (Autologous Expanded Stem Cell Line) or Hyaluronic Acid.

THE STEPS – TOTALIS™ TRIAL (Lumbar Stenosis Study)

The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct Decompression System or Sham Surgery in patients with lumbar spinal stenosis

CYTONICS CLINICAL TRIAL (Platelet Poor Plasma for Knee Pain)

APIC-CF Therapy for Mild to Moderate Osteoarthritis of the Knee.  The mechanism of Osteoarthritis (OA) is complex, however the investigators know that cartilage breakdown follows changes in certain cells in the cartilage called chondrocytes, leading to proteases that break down cartilage. There is a protein in the human blood called alpha-2-macroglobulin that can trap these proteases and prevent the breakdown of cartilage. Cytonics developed a device that use the patient’s own blood to remove all cells and concentrate alpha-2-macroglobulin to be injected in the painful knee due to osteoarthritis.

RELIEF CLINICAL TRIAL (Spinal Cord Stimulator Study for Chronic Pain)

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use and To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice.

PREVIOUS CLINICAL TRIALS

COOLIEF TRIAL (Knee Pain Study)

Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain. This study is designed to:

  • Determine the effectiveness (primarily measured by pain relief) of Coolief when used to create radiofrequency lesions of the genicular nerves compared to pain relief following corticosteroid injection; and
  • Confirm the safety of Coolief when used to perform radiofrequency lesions of the genicular nerves in subjects to manage knee pain compared to safety of corticosteroid injection

ACCURATE CLINICAL TRIAL

The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).

BIONESS NEUROSTIMULATOR

The purpose of this study is to investigate whether the StimRouter (SR) electrical stimulation therapy leads to clinically important pain relief in patients with chronic intractable pain of peripheral nerve origin after three months of treatment. At the same time, this study will gather information on side effects associated with the StimRouter electrical stimulation therapy.

SMART CLINICAL TRIAL

To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. This is a prospective, double-blind, randomized, sham-controlled clinical trial with an optional crossover component.

MESOBLAST INTRADISCAL CLINICAL TRIAL FOR DEGENERATIVE DISC DISEASE

Phase II FDA trial –  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 pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1.

All investigational subjects in this study will undergo injection of either 6 million (M) or 18M cells in a hyaluronic acid carrier into the degenerated lumbar disc’s nucleus pulposus. All control subjects will undergo an intradiscal control injection with either saline or hyaluronic acid only.

BIOSTAT INTRADISCAL CLINICAL TRIAL FOR DEGENERATIVE DISC DISEASE

Phase III FDA trial –  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 efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another group receiving a preservative-free normal saline control delivered with the Biostat Delivery Device.

GDF-5 INTRADISCAL CLINICAL TRIAL FOR DEGENERATIVE DISC DISEASE

Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.

OP-1 (BONE MORPHOGENETIC PROTEIN-7) INTRADISCAL CLINICAL TRIAL FOR DEGENERATIVE DISC DISEASE

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