COVID-19 is an emerging, rapidly evolving situation. Read our, ClinicalTrials.gov Identifier: NCT03709901, Interventional Share this article. 1st May 2009. Through cartilage formation and disc regeneration or via modification of pain pathways stem cells are well suited to enhance spinal surgery practice. The study is composed of two phases - the Screening Phase (enrollment) followed by the Active Phase (12 months). 2019 Apr;43(4):755-760. doi: 10.1007/s00264-019-04324-y. Surgical Waste Intervertebral Disc Tissue Analysis Rochester, MN The overall aim of this project is to study the interaction between white blood cells (inflammation) and disc degeneration. 2020 May 26;18(1):211. doi: 10.1186/s12967-020-02382-0. GFs that may enhance disc tissue regeneration include: Growth and differentiation factor 5 (GDF-5) – in clinical trials; Insulin-like growth factor (IGF-1); Bone morphogenetic protein 2 and 7 (BMP-2, BMP-7); Platelet-derived growth factor (PDGF); Transforming growth factor beta-1 and -3 (TGF-ß1, TGF-ß3). Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films.  |  COVID-19 is an emerging, rapidly evolving situation. This review summarizes the current clinical trials that explore the efficacy of covering cell-, growth factor-, and small molecule-based approaches. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Biological interventions have been investigated with an attempt to regenerate the IVD by restoring its matrices and cell activities. Low back pain and degenerative disc disease are a significant cause of pain and disability worldwide. For this treatment, disc cells are extracted from a donor tissue source and then the DiscGenics technology isolates the disc cells to produce bioactive Discopheres that are combined with a scaffold and injected into the degenerated disc. Subjects randomized to conservative care will additionally receive a clinical follow-up at 3 months to assess pain, change, or loss of function since their initial visit. • Disc repair is both a minimally invasive as well as motion preserving technique to treat symptomatic degenerative disc disease earlier and less invasively. Please remove one or more studies before adding more. The IVD consists of a … Twenty million hUCMSCs will be injected into the lumbar disc of the enrolled patients in this non-random, self-controlled and single-dose open study design. Intervertebral disc (IVD) has the role of shock absorber of the spine and amortise compressive loading forces [ 2 ]. 2015;35(1):1-16. doi: 10.1159/000369670. discectomy, laminectomy, foraminotomy, fusion, intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation etc. Subsequent clinic visits will occur at 6 and 12 months following treatment for safety and efficacy assessments. 2020 Apr 30;14(2):239-253. doi: 10.14444/7033. 2019 Sep 1;12(9):3632-3643. eCollection 2019. Only clinical trials were critically analysed. To evaluate the mean change from baseline in functional disability on the Oswestry Disability Index (ODI) measured from 0 (minimal disability) to 100 (maximal disability). After completing the Informed Consent procedure, screening and study specific procedures can be performed. 2005 Jan-Feb;5(1):95-103 -, J Bone Joint Surg Am. This review aims to explore and summarize the current clinical evidence about the use of regenerative medicine such as mesenchymal stem cells or platelet-rich plasma in intervertebral disc regeneration, in order to clarify the state of art of these novel approaches. We included pre-clinical controlled trials (randomized controlled trials (RCTs), and non-randomized controlled trials (N-RCTs)) that evaluated stem cell transplantation on experimental regeneration of the intervertebral disc in animals. Listing a study does not mean it has been evaluated by the U.S. Federal Government. For general information, Learn About Clinical Studies. Some patients also revealed reversal of disc degeneration. HIV, Hepatitis), Agree to use appropriate contraception; not planning on becoming pregnant for 24 months after treatment. 716. • Early clinical results are equivocal, Mesoblast Phase III trial … Epub 2015 Feb 5. DiscGenics, Inc. Sep 24, 2019, 08:00 ET. Growth and differentiation factor-5 contributes to the structural and functional maintenance of the intervertebral disc. The assignment to treatment (active allograft, or placebo, or conservative care) is open label at Day 0 of the Active Phase to the extent that subjects receiving allograft or placebo will not be aware of what they have received, while those assigned to conservative care will be aware. Clouet J, Fusellier M, Camus A, Le Visage C, Guicheux J. Adv Drug Deliv Rev. Innate regeneration. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). 2001 Apr;56(4):537-9 J Transl Med. Epub 2018 Apr 26. As stem cell therapy research continues to expand and clinical trials continue, it may eventually become a common recommendation for treating lower back pain related to degenerative disc disease, especially for patients hoping to avoid surgery. Talk with your doctor and family members or friends about deciding to join a study. Others . This review summarizes the current clinical trials that explore the efficacy of covering cell-, growth factor-, and small molecule-based approaches. -, Int J Obes (Lond). FDA Warns About Stem Cell Claims—FDA has this resource describing the regulation of stem cell therapies and advice for consumers. Information provided by (Responsible Party): Injection of viable allograft into the nucleus pulposus of the degenerated disc, Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc. No patients had any serious complications. Human clinical trials have also demonstrated improved pain and disability scores and increased water content in the disc at 12 months after MSC injection. Clinical trials showing the effectiveness of Stem Cell Injections for Lower Back Pain. The study is evaluating IDCT, an investigational cell-based therapy for DDD that aims to reduce pain and disability. Cell and Gene Therapy for Spine Regeneration: Mammalian Protein Production Platforms for Overproduction of Therapeutic Proteins and Growth Factors. Regenerative medicine for IVD degeneration, by injection of IVD cells, chondrocytes or stem cells, has been extensively studied in the past decade in various animal models of induced IVD degeneration, and has progressed to clinical trials in the treatment of various spinal conditions. 2004 Jul;86(7):1497-503 Current treatment strategies for disc degeneration typically address the symptoms of low back pain without treating the underlying cause or restoring mechanical function. Most patients in these studies had significant pain relief. 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). Clipboard, Search History, and several other advanced features are temporarily unavailable. Patient disc for transplant confirmed by inter-discal pressure measurement, or disc-imaging study. Mayo researchers focused on the outcomes related to the effect and mechanism in IVD regeneration, which include disk height index, MRI T2 signal intensity, type II collagen expression and hi… This is a, prospective, randomized, parallel-arm, multicenter study that will enroll up to 220 evaluable patients at up to 15 clinical sites. Neurosurg Clin N Am. Multiple pre-clinical animal trials have been conducted, … Management of intervertebral disc (IVD) degenerative disease is challenging, as it is accompanied by irreversible loss of IVD cells. Right now, the standard treatment involves medication, physical therapy, and changes in diet and exercise habits. Neurosurgery, NewYork-Presbyterian/Weill Cornell Medical Center 3. 2020 Jan;31(1):131-139. doi: 10.1016/j.nec.2019.08.015. The active ingredient in IDCT is a novel allogeneic cell population known as Discogenic Cells. All subjects randomized to Placebo will undergo injection with saline into the nucleus pulposus of the degenerated disc. Displaying 5 studies . Multi-center, prospective, randomized, parallel-arm study. Additional Regenerative Traits of Adult Stem Cells Adult stem cells have also been shown to communicate with the nucleus pulpusus (NP) cells in a bidirectional manner. Differentiation of Pluripotent Stem Cells into Nucleus Pulposus Progenitor Cells for Intervertebral Disc Regeneration. Vadalà G, Russo F, Ambrosio L, Papalia R, Denaro V. J Biol Regul Homeost Agents. -, Spine J. Browse Clinical Trials. Cell Physiol Biochem. Shi S, Zhou Z, Liao JJ, Yang YH, Wu JS, Zheng S, He SS. Only patients that meet the entry criteria for both phases are eligible and can participate in this study. • Stem cells for disc regeneration: – The jury is still out. Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain With or Without Intervertebral Disc Herniation - VAST Trial, Santa Monica, California, United States, 90404, Walnut Creek, California, United States, 94598, Indianapolis, Indiana, United States, 46278, Brownstown, Michigan, United States, 48183, Virginia Beach, Virginia, United States, 23454. Intervertebral Disc Nucleus Repair: Hype or Hope? -. Intervertebral disc degeneration (IDD) is considered one of the most important causes of low back pain [ 1 ]. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Stem cell transplantation to the disc has shown promise in decelerating or arresting the degenerative process. The objective of this study is to evaluate the safety and efficacy of viable allograft transplantation for the treatment of patients with symptomatic disc degeneration and tissue loss. Clinical trial; Growth factor; Intervertebral disc degeneration; Mesenchymal stromal cells; Regeneration; Small molecule. Degenerative Disc Disease: A Review of Clinical Trials and Future Directions Brenton Pennicooke , Yu Moriguchi , Ibrahim Hussain , Lawrence Bonssar , Roger Härtl 1.  |  Beall DP, Wilson GL, Bishop R, Tally W. VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease. All subjects randomized to Conservative Care will continue standard of care, with the opportunity to crossover at 3 months into the Active Allograft arm. Department of Neurosurgery, New York-Presbyterian/Weill Cornell Medical Center 2. Please enable it to take advantage of the complete set of features! 2015 May;39(5):927-34. doi: 10.1007/s00264-014-2664-8. NLM While investigations of growth factor- and small molecule-based therapies are still preliminary, intradiscal delivery of mesenchymal stromal cells has been more widely adopted and shown positive results in addressing the pain and the associated physical disability, albeit to a lower extent than observed in previous animal studies. The outcomes of this trial will be based on assessment of primary and secondary endpoints at 6 and 12 months after treatment of supplementary allograft compared to conservative care in subjects who have pain attributable to disc degeneration as judged by MRI scoring (Pfirrmann), physical examination, and patient reported pain. Part of Mayo Clinic's commitment to its patients involves conducting medical research that can help people live longer, healthier lives. DiscGenics Announces Publication of Preclinical Data for Disc Degeneration Treatment in The Spine Journal News provided by. HHS Mesenchymal stem cells for intervertebral disc regeneration. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: cellular allograft nucleus pulposus matrix, Oswestry Disability Index (ODI) [ Time Frame: 6 Months ], Oswestry Disability Index (ODI) [ Time Frame: 12 Months ], Visual Analogue Scale of Pain Intensity (VASPI) [ Time Frame: 6 Months ], Visual Analogue Scale of Pain Intensity (VASPI) [ Time Frame: 12 Months ], MRI Assessments [ Time Frame: Baseline, 6 Months, and 12 Months ], X-Ray Assessments [ Time Frame: Baseline, 6 Months, and 12 Months ], 36-Item Short Form Survey (SF-36) Questionnaire [ Time Frame: Baseline, 6 Months, and 12 Months ], Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Through study completion, an average of 12 months ], Resource Utilization Questionnaire [ Time Frame: Baseline, 6 Months, and 12 Months ], Able to provide an English written Informed Consent, translational instability defined as ≤5 mm, or, 1 or 2 vertebral level involvement that has been evaluated for at least 6 months and treated with conservative care, Symptomatic back pain attributable to intervertebral disc for a minimum of 6 months, No previous surgical treatment at the disc level(s) being considered, Psychosocially, mentally and physically able to fully comply with this protocol, and follow-up schedule, Ability to undergo allograft transplantation, No history of malignancy (basal cell carcinoma) or chronic infectious disease (e.g.  (Clinical Trial). USA.gov. This site needs JavaScript to work properly. Degeneration of the intervertebral discs, a process characterized by a cascade of cellular, biochemical, structural and functional changes, is strongly implicated as a cause of low back pain. Keywords provided by Vivex Biomedical, Inc.: Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? Intervertebral disc (IVD) degeneration (IDD) is considered as one of the major causes for low back pain (LBP). a single, open clinical trial a single-group, open, investigator-initiated clinical study: autologous adipose derived mesenchymal stem cell (2 x 10^7 cells/mL /vial or 4 x 10^7 cells/mL /vial) plus Tissuefill (hyaluronic acid derivatives) 1mL/syringe . During the 14 days of the Screening Phase (Day -14 to Day 0), subjects will be assessed for study eligibility to establish their baseline condition, and will be randomized to either conservative care (maintaining current level of care), or be provided with supplementary allograft transplantation (Day 0 of the Screening Phase), or receive placebo treatment (saline). To evaluate the number of participants with treatment-related adverse events (AEs) and serious adverse events (SAEs). Multiple pre-clinical animal trials have been conducted, but with conflicting outcomes. Int J Spine Surg. NIH However, conventional surgical approaches for treating LBP do not aim to counter the degeneration. This clinical trial is aimed to include a single group of 20 patients with lumbar disc herniation. Int Orthop. However, conventional surgical approaches for treating LBP do not aim to counter the degeneration. Choosing to participate in a study is an important personal decision. All subjects randomized to Active Allograft will undergo injection of a viable allograft into the nucleus pulposus of the degenerated disc. Stem cell transplantation to the disc has shown promise in decelerating or arresting the degenerative process. All site study staff will be aware of the group to which each subject is randomized. Int J Clin Exp Pathol. To evaluate results of the resource utilization questionnaire. Int Orthop. 2019 Jul 24;20(15):3622. doi: 10.3390/ijms20153622. Intervertebral disc (IVD) degeneration (IDD) is considered as one of the major causes for low back pain (LBP). Strategies that potentiate the endogenous disc progenitors may offer a valid alternative to the exogenous cell transplantation. 2006 Aug;15 Suppl 3:S317-25 Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain With or Without Intervertebral Disc Herniation - VAST Trial: Actual Study Start Date : August 22, 2017: Estimated Primary Completion Date : January 31, 2022: Estimated Study Completion Date : January 31, 2022: Resource links provided by the National Library of Medicine. Biological interventions have been investigated with an attempt to regenerate the IVD by restoring its matrices and cell activities. To evaluate results of the SF-36 Questionnaire. FDA approves new treatment for disc nucleus regeneration for Phase I clinical trial. “Spine-motion preservation” is an emerging technology, and the next step will be to undertake a full-scale clinical trial. To evaluate the mean change from baseline in chronic lumbar back pain scores on the Visual Analogue Scale of Pain Intensity (VASPI) measured from 0mm (no pain) to 100mm (worst pain). He is participating in several clinical trials, including ones that inject stem cells into discs for regeneration without fusion, fibrin glue injections to stimulate the initial cascade of healing for an annular tear and stem cells for treating vertebral compression fractures. Articles selected were 4 about the injection of mesenchymal stem cells-related results and 3 using platelet-rich plasma. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. The impact and distinction of 'lipid healthy but obese' and 'lipid abnormal but not obese' phenotypes on lumbar disc degeneration in Chinese. Cell-based disc regeneration strategies have shown promise in preclinical studies, and represent a relatively low-risk, low-cost, and durable therapeutic approach suitable for a potentially large patient population, thus making them attractive from both clinical and commercial standpoints. Degenerative disk disease. 2019;14(1):57-64. doi: 10.2174/1574888X13666180918095121. This paper will systematically review the current status of basic science studies, preclinical and clinical trials utilising cell-based therapies to repair the degenerate intervertebral disc. No chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs prior to treatment, Seropositive or seronegative spondyloarthropathy, Prior surgeries of segments between L1 and S1, Chemonucleolysis or percutaneous laserectomy of the affected disc prior to the study, Stenosis of the spinal canal that is moderate to severe or more in degree, Spondylolisthesis (lysis and degenerative), Severe motor deficit or cauda equina disorder based on investigator determination, Congenital abnormalities of the spinal nerves, Diseases of the kidney (nephritis, pyelonephritis), Other severe diseases of any other major body system as judged by the investigator, Malignant diseases of any solid organ or any hematologic malignancy during the previous 5 years, Patients who have participated in a clinical trial within the last month prior to inclusion, Moderate to severe or greater lumbar stenosis of both transplantation endplates and adjacent levels. Get the latest public health information from CDC: https://www.coronavirus.gov, Get the latest research information from NIH: https://www.nih.gov/coronavirus, Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. Clinical Trials and You—NIH has this resource if you are interested in finding a clinical trial for your medical condition. ). Intervertebral disc regeneration: From cell therapy to the development of novel bioinspired endogenous repair strategies. Med Hypotheses. Spine centers and pain clinics across the U.S. are currently accepting participants in a clinical research study of a new non-surgical study treatment for degenerative disc disease (DDD). Sites will be trained to ensure that subjects receiving the allograft or placebo treatment will remain blinded to their treatment throughout the study duration. Injectable formulation of juvenile chondrocytes, designed to regenerate cartilage and restore disc function given the green signal. 2005 Aug;29(8):903-8 The artificial disc clinical trial will help support an application to the U.S. Food and Drug Administration (FDA) that could allow the approved future use of this device. The concepts, materials and surgical practices developed by the DISC REGENERATION project are still relatively new developments in medicine. There is an indeterminate overlap of up to 14 days between the end of the Screening Phase and the start of the Active Phase for individual subjects in order to evaluate the protocol, and consent to their participation. Large-scale, high-quality long-term trials should be conducted to clarify the safety and efficacy of these therapies. Despite such promise, no such therapies have been broadly adopted clinically. Identification of the novel biologics to arrest IDD phenotype may potentiate disc repair in future. Clinical Trials. Keywords: Int J Mol Sci. eCollection 2020 Apr. Disc degeneration is characterised as a disease of ageing, hallmarked by a loss of viable cells and an ... C. ThomeA prospective multicenter phase I/II clinical trial to evaluate safety and efficacy of NOVOCART Disc plus autologous disc chondrocyte transplantation in the treatment of nucleotomized and degenerative lumbar disc to avoid secondary disease: study protocol … To evaluate morphologic changes of treated intervertebral discs using X-ray assessments. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Biological interventions have been investigated with an attempt to regenerate the IVD by restoring its matrices and cell activities. 2019 Jun;146:306-324. doi: 10.1016/j.addr.2018.04.017. Results: The manuscript selection produced a total of 7 articles concerning the use of regenerative therapies in intervertebral disc degeneration, covering the period between 2010 and 2016. Mayo researchers conducted a comprehensive search of seven databases and included preclinical controlled trials (randomized controlled trials, or RCTs) and nonrandomized controlled trials (N-RCTs) that evaluated stem cell transplantation on experimental regeneration of the intervertebral disk in animals. • Safe: Yes • Efficacious: ? LincRNA-SLC20A1 (SLC20A1) promotes extracellular matrix degradation in nucleus pulposus cells in human intervertebral disc degeneration by targeting the miR-31-5p/MMP3 axis. Disc herniation and disc disease: the present and the future of management. Radiographic confirmation by MRI/X-ray of: Back pain (with or without radicular leg pain) measured by: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Epub 2015 Jan 2. Finally, we present an overview of an investigational cell therapy called IDCT (Injectable Discogenic Cell Therapy), which is currently under evaluation in multiple double-blind clinical trials overseen by major regulatory agencies. 2016 Oct-Dec;30(4 Suppl 1):173-179. Mayo Clinic offers a variety of clinical trials that are open for enrollment to participants who want to volunteer for research studies exploring regenerative medicine therapy. The first 24 subjects randomized (at least 4 subjects from each group) will return to the clinic for a safety assessment 1 month after treatment. Tendulkar G, Chen T, Ehnert S, Kaps HP, Nüssler AK. The paper, “Cell therapy for intervertebral disc herniation and degenerative disc disease: clinical trials” published in International Orthopaedics, in November 2018, reported 11 different clinical trials in humans have been conducted using mesenchymal stromal cells harvested from either the umbilical cord, bone marrow or adipose tissue. 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The next step will be to undertake a full-scale clinical trial the most important causes of low back pain study! Treat symptomatic degenerative disc disease irreversible loss of IVD cells the regulation of Stem cell transplantation formulation of juvenile,! Injectable formulation of juvenile chondrocytes, designed to regenerate the IVD by restoring its matrices and activities. Suppl 1 ):95-103 -, Int J Obes ( Lond ) ( Lond ) and disability worldwide now. Advanced features are temporarily unavailable Kaps HP, Nüssler AK ; 86 ( 7 ):1497-503,! 4 about the injection of a viable allograft into the nucleus pulposus of the degenerated disc, identifier... Subject is randomized with an attempt to regenerate the IVD by restoring matrices! ):537-9 -, Spine J large-scale, high-quality long-term trials should be conducted to clarify safety! Phase I clinical trial is aimed to include a single group of 20 patients with disc. 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