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Analysis of Orthobiologic Agents (OBA) for Painful Musculoskeletal Conditions and Tissue Regeneration (BMAC)
Jacksonville, Fla.
The objectives of this study are to determine the effect of patient factors and manufacturing procedures on OBA product characteristics, to assess the clinical outcomes of patients affected by multiple painful musculoskeletal disorders and tissue regeneration needs that are treated with guided procedures in the Mayo Clinic Pain practice, to assess genetic and epigenetic factors associated to multiple painful musculoskeletal disorders and tissue regeneration needs, to determine the effect of OBA characteristics on patient outcomes for patients treated with OBA procedures, including a reference group of patients not receiving OBAs as part of their medical care.
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A Prospective, Randomized, Double-Blinded, Sham-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of IDCT In Subjects With Single-Level, Symptomatic Mild To Moderate Lumbar Intervertebral Disc Degeneration
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration. The study will have a 52-week primary period followed by 52 week Follow-up Period (total of 104 weeks).
The study protocol will be approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and the study will be conducted in accordance with Good Clinical Practice (GCP). All subjects will provide written informed consent prior to Screening.
Approximately 162 subjects will be enrolled in the study. Up to 45 days prior to treatment, subjects will be screened for study inclusion, which includes obtaining baseline MRI and X-ray imaging. Imaging results for subjects initially eligible for study participation will be sent to a central imaging vendor for review and confirmation of eligibility, including the number of levels with degeneration. Subjects meeting all inclusion/exclusion criteria will be assigned to the corresponding treatment arm group and subsequently randomized to IDCT or Sham.
Randomization will occur approximately 7 to 14 days prior to the scheduled treatment administration date.
Overall, 162 subjects will be enrolled and randomized to IDCT or Sham in a 2:1 ratio.
* IDCT (n=108)
* Sham (n=54)
Closed for Enrollment
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A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain (MSB-DR003)
Rochester, Minn.
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 low back pain (> 6 months) associated with moderate radiographic degenerative changes of a disc
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CELLKINE: Phase I Study Evaluating the Safety and Feasibility of Allogeneic, Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells in Subjects with Painful Lumbar Facet Joint Arthropathies
Jacksonville, Fla.
The purpose of this study is to determine the safety and feasibility of allogeneic, culture-expanded BM-MSCs in subjects with painful facet joint arthropathy.
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Cellkine: Phase II Study Evaluating Safety and Preliminary Efficacy of Allogeneic, Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells in Subjects with Painful Lumbar Facet Joint Arthropathies (CELLKINE P2)
Jacksonville, Fla.
The purpose of this study is to determine the safety and preliminary effectiveness of allogeneic, culture-expanded BM-MSCs in subjects with painful facet joint arthropathy.
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Collection of Surgical Waste Synovium Tissue and Waste Synovial Fluid from Elective Joint Aspirations
Rochester, Minn.
The purpose of this study is to see if the inflammation in early stage arthritis can be cessated by changing synoviocyte-macrophage interactions in a way that macrophages do not get activated.
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Phase I Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury (CELLTOP)
Rochester, Minn.
The purpose of this study is to determine if mesenchymal stem cells (MSC) derived from the fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury. Adipose-derived mesenchymal stem cells (AD-MSCs) have been used in previous research studies at the Mayo Clinic. All subjects enrolled in this study will receive AD-MSC treatment, which is still experimental and is not approved by the U.S. Food and Drug Administration (FDA) for large scale use. However, the FDA has allowed the use of this agent in this research study.
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Surgical Waste Intervertebral Disc Tissue Analysis
Rochester, Minn.
The overall aim of this project is to study the interaction between white blood cells (inflammation) and disc degeneration.
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The Effectiveness And Safety Of Traditional Korean Medicine For Symptomatic Lumbar Spinal Spondylolisthesis: A Randomized Controlled International Collaborative Multi-Center Trial
Rochester, Minn.
This research is being done, in a joint-effort between Mayo Clinic and the Mokhuri Oriental Medical Hospital, to evaluate the effectiveness and safety of two different types of non-surgical treatment in patients with symptomatic lumbar spinal spondylolisthesis.
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