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Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy.

ABSTRACT: BACKGROUND:Degenerative disc disease (DDD) is a common cause of lower back pain with radicular symptoms and has a significant socioeconomic impact given the associated disability. Limited effective conservative therapeutic options result in many turning to surgical alternatives for management, which vary in the rate of success and also carry an increased risk of morbidity and mortality associated with the procedures. Several animal based studies and a few human pilot studies have demonstrated safety and suggest efficacy in the treatment of DDD with mesenchymal stem cells (MSCs). The use of bone marrow-derived MSCs for the treatment of DDD is promising and in the present study we report on the safety and efficacy findings from a registry based proof of concept study using a percutaneous intradiscal injection of cultured MSCs for the management of DDD with associated radicular symptoms. METHODS:Thirty-three patients with lower back pain and disc degeneration with a posterior disc bulge diagnosed on magnetic resonance imaging (MRI) met the inclusion criteria and were treated with culture-expanded, autologous, bone marrow-derived MSCs. Prospective registry data was obtained at multiple time intervals up to 6 years post-treatment. Collected outcomes included numeric pain score (NPS), a modified single assessment numeric evaluation (SANE) rating, functional rating index (FRI), measurement of the intervertebral disc posterior dimension, and adverse events. RESULTS:Three patients reported pain related to procedure that resolved. There were no serious adverse events (i.e. death, infection, or tumor) associated with the procedure. NPS change scores relative to baseline were significant at 3, 36, 48, 60, and 72 months post-treatment. The average modified SANE ratings showed a mean improvement of 60% at 3 years post-treatment. FRI post-treatment change score averages exceeded the minimal clinically important difference at all time points except 12 months. Twenty of the patients treated underwent post-treatment MRI and 85% had a reduction in disc bulge size, with an average reduction size of 23% post-treatment. CONCLUSIONS:Patients treated with autologous cultured MSCs for lower back pain with radicular symptoms in the setting of DDD reported minor adverse events and significant improvements in pain, function, and overall subjective improvement through 6 years of follow-up. NCT03011398. A Clinical Registry of Orthobiologics Procedures. https://clinicaltrials.gov/ct2/show/NCT03011398?term=orthobiologics&rank=1.

SUBMITTER: Centeno C

PROVIDER: S-EPMC5610473 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy.

Centeno Christopher C Markle Jason J Dodson Ehren E Stemper Ian I Williams Christopher J CJ Hyzy Matthew M Ichim Thomas T Freeman Michael M

Journal of translational medicine 20170922 1

<h4>Background</h4>Degenerative disc disease (DDD) is a common cause of lower back pain with radicular symptoms and has a significant socioeconomic impact given the associated disability. Limited effective conservative therapeutic options result in many turning to surgical alternatives for management, which vary in the rate of success and also carry an increased risk of morbidity and mortality associated with the procedures. Several animal based studies and a few human pilot studies have demonst ...[more]

PMID: 28938891

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Project description:Objective The objective of the present study was to explore the diversity, quality, severity and distribution of symptoms in patients with radicular pain and a lumbar disc herniation. Design Longitudinal cohort study. Setting Hospital-based back clinic. Participants Ninety patients referred to secondary healthcare with (a) low back-related leg pain, (b) age between 18 and 65 years and (c) MRI confirmed lumbar disc herniation at a relevant side and level. Outcome measures Neuropathic pain symptoms were assessed using the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) and the painDETECT Questionnaire. In a subsample classified with neuropathic pain, in-depth interviews were performed, and symptomatic areas were drawn on standardised body charts. Results At baseline, the most frequently used painDETECT symptom descriptor was numbness sensation, reported by 94%, followed by sudden pain attacks and tingling or prickling. The mean (SD) SF-MPQ-2 score (0–10) for aching pain was 5.9 (2.8); numbness 4.3 (3.3); tingling 4.0 (3.4); burning 2.6 (3.1); pain caused by light touch 1.5 (2.6). Leg pain was rated as extremely bothersome by 73%, numbness and tingling by 38%, weakness by 24% and back pain by 17%. In the subsample (n=52), deep-lying pain and non-painful abnormal sensations were frequent, at 71% and 85%. Drawings demonstrated substantial overlap between symptoms from compromised L5 and the S1 nerve roots. Painful and non-painful symptoms improved at approximately the same rate. At the 1-year follow-up, 45% (14/31) of patients who had received disc surgery, and 34% (18/53) of those who had received conservative treatment reported no bothersome back pain, leg pain, numbness/tingling or weakness. Conclusion Patients reported several highly bothersome symptoms, but not all are described as painful. The overall symptom profile of lumbar disc-related radicular pain differs from other neuropathic pain conditions with limited allodynia and thermal hyperalgesia. Symptomatic areas for the L5 and S1 nerve roots have a large overlap.

Project description:BackgroundNo proof of efficacy, in the form of a randomized controlled trial (RCT), exists to support pulsed radiofrequency (PRF) treatment of the dorsal root ganglion (DRG) for chronic lumbar radicular (CLR) pain. We determined the feasibility of a larger trial (primary objective), and also explored the efficacy of PRF in decreasing pain on a visual analog scale (VAS) and improving the Oswestry Disability Index.MethodsThis was a single-center, placebo-controlled, triple-blinded RCT. Patients were randomized to a placebo group (needle placement) or a treatment group (PRF at 42°C for 120 seconds to the DRG). Patients were followed up for 3 months post procedure. Outcomes with regard to pain, Oswestry Disability Index score, and side effects were analyzed on an intention-to-treat basis.ResultsOver 15 months, 350 potential patients were identified and 56 were assessed for eligibility. Fifteen of them did not meet the selection criteria. Of the 41 eligible patients, 32 (78%) were recruited. One patient opted out before intervention. Three patients were lost to follow-up at 3 months. Mean VAS differences were not significantly different at 4 weeks (-0.36, 95% confidence interval [CI], -2.29, 1.57) or at 3 months (-0.76, 95% CI, -3.14, 1.61). The difference in mean Oswestry Disability Index score was also not significantly different at 4 weeks (-2%, 95% CI, -14%, 10%) or 3 months (-7%, 95% CI, -21%, 6%). There were no major side effects. Six of 16 patients in the PRF group and three of 15 in the placebo group showed a >50% decrease in VAS score.ConclusionThe recruitment rate was partially successful. At 3 months, the relative success of PRF-DRG was small. A large-scale trial to establish efficacy is not practically feasible considering the small effect size, which would necessitate recruitment of a challengingly large number of participants over a number of years. Until clear parameters for application of PRF are established, clinicians will need to use their individual judgment regarding its clinical applicability, given the present evidence.

Project description:Background contextSpine surgeons must correlate clinical presentation with radiographic findings in a patient-tailored approach. Despite the prevalence of adult degenerative scoliosis (ADS), there are few radiographic markers to predict the presence of radiculopathy. Emerging data suggest that spondylolisthesis, obliquity, foraminal stenosis, and curve concavity may be associated with radiculopathy in ADS.PurposeThe purpose of this study was to determine if radicular pain in ADS is associated with reduced interpedicular heights (IPHs) as measured on routine radiographs.Study design/settingThis is a retrospective case-controlled study.Patient sampleThe authors carried out a retrospective chart review at a tertiary care referral center that included ADS patients referred to scoliosis surgeons between 2012 and 2014. Inclusion criteria included patients with ADS and no prior thoracolumbar surgery. Data were collected from initial spine surgeon clinic notes and radiographs.Outcome measuresClinical outcome data included presence, side(s), and level(s) of radicular pain; presence of motor deficits; and presence of sensory deficits.MethodsVariables included age, gender, Scoliosis Research Society-30 (SRS-30) and Oswestry Disability Index (ODI) questionnaire data, and radiographic measurements. Radiographic measurements included Cobb angles and L1 to S1 IPHs on upright and supine radiographs. Associations between variables and outcome measures were assessed with univariate and multivariate statistical analyses. Authors have no conflicts of interests relevant to this study.ResultsA total of 200 patients with an average age of 51 years met the inclusion criteria. Sixty of the 200 patients presented with radicular pain. Older age was associated with radicular pain, weakness, and sensory deficits. Patients who were 55 years or older were approximately eight times more likely to have radicular pain (odds ratio [OR]=7.96, 95% confidence interval [CI]: 3.73, 17.0; p<.001), five times more likely to have motor deficit (OR=5, 95% CI: 2.55, 9.79; p<.001), and five times more likely to have sensory deficit (OR=5.2, 95% CI: 2.65, 10.2; p<.001) than those younger than 55. More caudally located nerve roots are more likely to develop radicular pain (p<.001). Motor deficits were associated with worse SRS-30 functional (p=.02) and ODI scores (p=.005), but radicular pain and sensory deficits were not associated with lower SRS-30 or ODI scores. Ipsilateral and same-level radicular pain were associated with reduced IPH on supine radiographs (p=.002 and p=.0002, respectively). Finally, reduced IPH on upright radiographs was associated with side- and level-specific radicular pain (p=.04).ConclusionsRadicular pain in ADS patients is associated with reduced IPHs and older age. Measuring IPHs on routine radiographs may be helpful in associating clinical radiculopathy with radiographic measures to guide patient management and surgical planning.

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Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy.

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Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy.

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