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We conducted a randomized, open-label, phase I\/IIa study to determine the feasibility, safety, and effectiveness of Wharton's jelly-derived mesenchymal stem cells (WJ-MSCs) and teriparatide (parathyroid hormone 1-34) in OVCFs. Twenty subjects with recent OVCFs were randomized to teriparatide (20\u2009\u03bcg\/day, daily subcutaneous injection for 6 months) treatment alone or combined treatment of WJ-MSCs (intramedullary [4 \u00d7\u2009107 cells] injection and intravenous [2 \u00d7\u2009108 cells] injection after 1 week) and teriparatide (20\u2009\u03bcg\/day, daily subcutaneous injection for 6 months). Fourteen subjects (teriparatide alone, n = 7; combined treatment, n = 7) completed follow-up assessment (visual analog scale [VAS], Oswestry Disability Index [ODI], Short Form-36 [SF-36], bone mineral density [BMD], bone turnover measured by osteocalcin and C-terminal telopeptide of type 1 collagen, dual-energy x-ray absorptiometry [DXA], computed tomography [CT]). Our results show that (a) combined treatment with WJ-MSCs and teriparatide is feasible and tolerable for the patients with OVCFs; (b) the mean VAS, ODI, and SF-36 scores significantly improved in the combined treatment group; (c) the level of bone turnover markers were not significantly different between the two groups; (d) BMD T-scores of spine and hip by DXA increased in both control and experimental groups without a statistical difference; and (e) baseline spine CT images and follow-up CT images at 6 and 12\u2009months showed better microarchitecture in the combined treatment group. Our results indicate that combined treatment of WJ-MSCs and teriparatide is feasible and tolerable and has a clinical benefit for fracture healing by promoting bone architecture. Clinical trial registration: https:\/\/nedrug.mfds.go.kr\/, MFDS: 201600282-30937.<\/jats:p>","DOI":"10.1002\/sctm.20-0308","type":"journal-article","created":{"date-parts":[[2020,12,17]],"date-time":"2020-12-17T23:20:11Z","timestamp":1608247211000},"page":"554-567","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":50,"title":["Safety and efficacy of Wharton's jelly-derived mesenchymal stem cells with teriparatide for osteoporotic vertebral fractures: A phase I\/IIa study"],"prefix":"10.1093","volume":"10","author":[{"given":"JeongHyun","family":"Shim","sequence":"first","affiliation":[{"name":"Department of Neurosurgery Shim Jeong Hospital, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyoung-Tae","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, School of Medicine Kyungpook National University, Daegu, South Korea"},{"name":"Department of Neurosurgery Kyungpook National University Hospital, Daegu, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kwang Gi","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Biomedical Engineering, College of Medicine Gachon University, Seongnam-si, South Korea"},{"name":"Department of Health Sciences and Technology, Gachon Advanced Institute for Health Sciences and Technology (GAIHST) Gachon University, Seongnam-si, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Un-Yong","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery CHA University School of Medicine, CHA Bundang Medical Center, Seongnam-si, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jae Won","family":"Kyung","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery CHA University School of Medicine, CHA Bundang Medical Center, Seongnam-si, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seil","family":"Sohn","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery CHA University School of Medicine, CHA Bundang Medical Center, Seongnam-si, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang Heon","family":"Lim","sequence":"additional","affiliation":[{"name":"Department of Biomedical Engineering, College of Medicine Gachon University, Seongnam-si, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyemin","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery CHA University School of Medicine, CHA Bundang Medical Center, Seongnam-si, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tae-Keun","family":"Ahn","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery CHA University School of Medicine, CHA Bundang Medical Center, Seongnam-si, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hye Jeong","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Radiology CHA University School of Medicine, CHA Bundang Medical Center, Seongnam-si, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong-Eun","family":"Shin","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery CHA University School of Medicine, CHA Bundang Medical Center, Seongnam-si, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inbo","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery CHA University School of Medicine, CHA Bundang Medical Center, Seongnam-si, South 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