Safety and efficacy of Wharton's jelly-derived mesenchymal stem cells with teriparatide for osteoporotic vertebral fractures: A phase I/IIa study
DC Field | Value | Language |
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dc.contributor.author | Shim, JeongHyun | - |
dc.contributor.author | Kim, Kyoung-Tae | - |
dc.contributor.author | Kim, Kwang Gi | - |
dc.contributor.author | Choi, Un-Yong | - |
dc.contributor.author | Kyung, Jae Won | - |
dc.contributor.author | Sohn, Seil | - |
dc.contributor.author | Lim, Sang Heon | - |
dc.contributor.author | Choi, Hyemin | - |
dc.contributor.author | Ahn, Tae-Keun | - |
dc.contributor.author | Choi, Hye Jeong | - |
dc.contributor.author | Shin, Dong-Eun | - |
dc.contributor.author | Han, Inbo | - |
dc.date.available | 2021-03-29T01:40:40Z | - |
dc.date.created | 2020-12-21 | - |
dc.date.issued | 2021-04 | - |
dc.identifier.issn | 2157-6564 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/80568 | - |
dc.description.abstract | Osteoporotic vertebral compression fractures (OVCFs) are serious health problems. 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 μg/day, daily subcutaneous injection for 6 months) treatment alone or combined treatment of WJ-MSCs (intramedullary [4 × 107 cells] injection and intravenous [2 × 108 cells] injection after 1 week) and teriparatide (20 μg/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 months 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. © 2020 The Authors. STEM CELLS TRANSLATIONAL MEDICINE published by Wiley Periodicals LLC on behalf of AlphaMed Press | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | WILEY | - |
dc.relation.isPartOf | Stem Cells Translational Medicine | - |
dc.title | Safety and efficacy of Wharton's jelly-derived mesenchymal stem cells with teriparatide for osteoporotic vertebral fractures: A phase I/IIa study | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000599080900001 | - |
dc.identifier.doi | 10.1002/sctm.20-0308 | - |
dc.identifier.bibliographicCitation | Stem Cells Translational Medicine, v.10, no.4, pp.554 - 567 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.scopusid | 2-s2.0-85097539945 | - |
dc.citation.endPage | 567 | - |
dc.citation.startPage | 554 | - |
dc.citation.title | Stem Cells Translational Medicine | - |
dc.citation.volume | 10 | - |
dc.citation.number | 4 | - |
dc.contributor.affiliatedAuthor | Kim, Kwang Gi | - |
dc.contributor.affiliatedAuthor | Lim, Sang Heon | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | mesenchymal stem cells | - |
dc.subject.keywordAuthor | osteoporosis | - |
dc.subject.keywordAuthor | teriparatide | - |
dc.subject.keywordAuthor | vertebral compression fracture | - |
dc.subject.keywordAuthor | Wharton&apos | - |
dc.subject.keywordAuthor | s jelly | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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