{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,10]],"date-time":"2026-11-10T15:23:42Z","timestamp":1794324222829,"version":"4.9.0"},"reference-count":66,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["SPI"],"published-print":{"date-parts":[[2013,1]]},"abstract":"<jats:sec>\n                    <jats:title>Object<\/jats:title>\n                    <jats:p>The purpose of the study was to evaluate the safety and initial efficacy of NuQu allogeneic juvenile chondrocytes delivered percutaneously for the treatment of lumbar spondylosis with mechanical low-back pain (LBP). NuQu is a cell-based biological therapy for disc repair. The authors report the results at 12 months of the NuQu Phase I investigational new drug (IND) single-arm, prospective feasibility study for the treatment of LBP for single-level degenerative disc disease (Pfirrman Grades III\u2013IV) at L3\u2013S1.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Fifteen patients (6 women and 9 men) were enrolled at 2 sites. Institutional review board approval was obtained, and all patients signed a study-specific informed consent. All patients have completed a minimum of 1 year of follow-up.<\/jats:p>\n                    <jats:p>Patients were evaluated pretreatment and at 1, 3, 6, and 12 months posttreatment. Evaluations included routine neurological examinations, serum liver and renal function studies, MRI, the Oswestry Disability Index (ODI), the Numerical Rating Scale (NRS), and the 36-Item Short Form Health Survey (SF-36).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Fifteen patients were treated with a single percutaneous delivery of NuQu juvenile chondrocytes. The mean patient age was 40 years (19\u201347 years). Each treatment consisted of 1\u20132 ml (mean injection 1.3 ml) of juvenile chondrocytes (approximately 10\n                      <jats:sup>7<\/jats:sup>\n                      chondrocyte cells\/ml) with fibrin carrier. The mean peak pressure during treatment was 87.6 psi. The treatment time ranged from 5 to 33 seconds.\n                    <\/jats:p>\n                    <jats:p>The mean ODI (baseline 53.3, 12-month 20.3; p &lt; 0.0001), NRS (baseline 5.7, 12-month 3.1; p = 0.0025), and SF-36 physical component summary (baseline 35.3, 12-month 46.9; p = 0.0002) scores all improved significantly from baseline. At the 6-month follow-up, 13 patients underwent MRI (one patient underwent CT imaging and another refused imaging). Ten (77%) of these 13 patients exhibited improvements on MRI. Three of these patients showed improvement in disc contour or height. High-intensity zones (HIZs), consistent with posterior anular tears, were present at baseline in 9 patients. Of these, the HIZ was either absent or improved in 8 patients (89%) by 6 months. The HIZ was improved in the ninth patient at 3 months, with no further MRI follow-up. Of the 10 patients who exhibited radiological improvement at 6 months, findings continued to improve or were sustained in 8 patients at the 12-month follow-up. No patient experienced neurological deterioration. There were no disc infections, and there were no serious or unexpected adverse events. Three patients (20%) underwent total disc replacement by the 12-month follow-up due to persistent, but not worse than baseline, LBP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This is a 12-month report of the clinical and radiographic results from a US IND study of cell-based therapy (juvenile chondrocytes) in the treatment of lumbar spondylosis with mechanical LBP. The results of this prospective cohort are promising and warrant further investigation with a prospective, randomized, double-blinded, placebo-controlled study design. Clinical trial registration no.: BB-IND 13985.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3171\/2012.10.spine12512","type":"journal-article","created":{"date-parts":[[2012,11,9]],"date-time":"2012-11-09T10:04:16Z","timestamp":1352455456000},"page":"85-95","source":"Crossref","is-referenced-by-count":109,"title":["Prospective study of disc repair with allogeneic chondrocytes Presented at the 2012 Joint Spine Section Meeting"],"prefix":"10.3171","volume":"18","author":[{"given":"Domagoj","family":"Coric","sequence":"first","affiliation":[{"name":"Carolina Neurosurgery and Spine Associates;"},{"name":"Department of Neurosurgery, Carolinas Medical Center, Charlotte, North Carolina; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Pettine","sequence":"additional","affiliation":[{"name":"Loveland Orthopedic Clinic, Loveland, Colorado"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Sumich","sequence":"additional","affiliation":[{"name":"Carolina Neurosurgery and Spine Associates;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret O.","family":"Boltes","sequence":"additional","affiliation":[{"name":"Carolina Neurosurgery and Spine Associates;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"key":"b1-spine12512","series-title":"Tissue Eng Part A","doi-asserted-by":"publisher","first-page":"3045","DOI":"10.1089\/ten.tea.2011.0229","article-title":"Porcine intervertebral disc repair using allogeneic juvenile articular chondrocytes or mesenchymal stem cells","volume":"17","author":"Acosta","year":"2011"},{"key":"b2-spine12512","series-title":"Stem Cell Res (Amst)","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1016\/j.scr.2009.09.004","article-title":"Immune evasion by neocartilage-derived chondrocytes: Implications for biologic repair of joint articular cartilage","volume":"4","author":"Adkisson","year":"2010"},{"key":"b3-spine12512","series-title":"J Clin Invest","doi-asserted-by":"publisher","first-page":"996","DOI":"10.1172\/JCI118884","article-title":"The human lumbar intervertebral disc: evidence for changes in the biosynthesis and denaturation of the extracellular matrix with growth, maturation, ageing, and degeneration","volume":"98","author":"Antoniou","year":"1996"},{"key":"b4-spine12512","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"2510","DOI":"10.1097\/BRS.0b013e3181af2622","article-title":"Segmental contribution toward total lumbar range of motion in disc replacement and fusions: a comparison of operative and adjacent levels","volume":"34","author":"Auerbach","year":"2009"},{"key":"b5-spine12512","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1245","DOI":"10.1097\/00007632-200206010-00020","article-title":"New technologies in spine: nucleus replacement","volume":"27","author":"Bao","year":"2002"},{"key":"b6-spine12512","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"1706","DOI":"10.1007\/s00586-009-1136-0","article-title":"An injectable nucleus replacement as an adjunct to microdiscectomy: 2 year follow-up in a pilot clinical study","volume":"18","author":"Berlemann","year":"2009"},{"key":"b7-spine12512","series-title":"J Neurosurg Spine","doi-asserted-by":"publisher","first-page":"91","DOI":"10.3171\/spi.2006.4.2.91","article-title":"Treatment of symptomatic adjacent-segment degeneration after lumbar fusion with total disc arthroplasty by using the prodisc prosthesis: a prospective study with 2-year minimum follow up","volume":"4","author":"Bertagnoli","year":"2006"},{"key":"b8-spine12512","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1565","DOI":"10.1097\/01.brs.0000170587.32676.0e","article-title":"A prospective, randomized, multi-center Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion. 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