Back Pain Clinical Trial
Official title:
An Open Label Dose Escalation Pilot Study to Evaluate the Safety of Alocyte Delivered Via Intra-articular Facet Injection for the Treatment of Facetogenic Back Pain
The purpose of this study is to see if the use of Alocyte (cord blood plasma plus mononucleic cells) will be safe, well tolerated, and whether it causes any side effects. The study will also examine if the use of the Investigational Product (IP) is able to reduce local inflammation or alleviate Facetogenic back pain
Ghormley, in 1933, was the first to perform oblique spine radiographs to view the zygapophysial or facet joints and coin the term "facet syndrome" to refer to LBP with "sciatica" originating from the facet joints. The facet joint may be affected by systemic disease, such as rheumatoid arthritis and ankylosing spondylitis, or be site of micro traumatic fractures, such as osteoarthritis, meniscoid entrapment, synovial impingement, joint subluxation, synovial inflammation, loss of cartilage, and mechanical injury. Facetogenic pain is the result of repetitive stress and/or cumulative low-level trauma, leading to inflammation and stretching of the joint capsule. Current treatment options for this disease are limited to symptomatic treatment, including analgesics, physiotherapy, and minimally invasive or surgical treatment (spinal fusion or non-fusion), but none of the methods addresses the underlying problem. The pathological process of intervertebral disc degeneration cannot be prevented by these therapies. Alocyte is a cellular, minimally manipulated product derived from umbilical cord blood. Alocyte's manufacturing methodology is designed to enrich human umbilical cord plasma and human umbilical cord blood-derived mononuclear cells (hematopoietic lineage cells such as lymphocytes, monocytes, stem and progenitor cells, as well as mesenchymal stem cells) present in full-term cord blood. The final product is composed of a heterogenous population of cellular products, mainly the exosomes, cytokines, and nucleated cells. Cytokine expression of Alocyte was fully evaluated. Alocyte showed a robust expression of RANTES, Osteopontin, and Angiostatin where the first two are stem cell repair cytokines and the latter is pro-angiogenic cytokine. Other cytokine showed moderate levels are IL-8, PDGF-BB, TIMP-1, TIMP-2, Angiopoietin-1, Angiogenin, MMP-9, Tie-2, uPAR, BDNF, TGF-ß2, GRO, IGFBP-1, IGFBP-2, IL-8, IL-12-p40, MIF, and NAP-2. Alocyte contained a variety of pro-angiogenic, immune-modulatory, anti-inflammatory, pro-metabolism, and tissue repair growth factors. Therefore, a regenerative approach for treating Facetogenic pain will be beneficial by promoting changes in the pathogenic mechanism triggered by the cellular therapeutic product Alocyte. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05982483 -
Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain
|
N/A | |
Completed |
NCT04744246 -
Muscle Activity During Load Carriage in ROTC Cadets
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Active, not recruiting |
NCT03680846 -
Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain
|
N/A | |
Completed |
NCT05597189 -
Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain
|
N/A | |
Completed |
NCT05342181 -
Static and Dynamic Core Stability Exercises in Potpartum Back Pain
|
N/A | |
Completed |
NCT02955342 -
Back and Neck Pain in Adolescence
|
||
Not yet recruiting |
NCT02536274 -
"Examination of the Impact of a Dynamic Flexion Orthosis (Dynaflex®Ottobock) or of a Back Bandage (Lumbo Sensa®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Back Pain"
|
N/A | |
Completed |
NCT02704845 -
Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain
|
N/A | |
Recruiting |
NCT02237105 -
The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery
|
N/A | |
Enrolling by invitation |
NCT02485795 -
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
|
N/A | |
Terminated |
NCT02239627 -
Epidural Clonidine Versus Corticosteroid for Low Back Pain
|
N/A | |
Completed |
NCT02254694 -
The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body
|
N/A | |
Completed |
NCT02609009 -
Back Pain and Spinal Manipulation in Adolescent Scoliosis
|
N/A | |
Completed |
NCT00986180 -
NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
|
Phase 3 | |
Completed |
NCT00771758 -
Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
|
Phase 3 | |
Terminated |
NCT00769626 -
Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy
|
Phase 3 | |
Withdrawn |
NCT00231374 -
Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning
|
N/A | |
Completed |
NCT00103675 -
Sensor Measurement of Acupuncture Needle Manipulation
|
Phase 1 | |
Completed |
NCT00454064 -
Cognitive-behavioural Treatment of Chronic Back Pain
|
Phase 3 |