Safety and efficacy of Wharton's jelly-derived mesenchymal stem cells with teriparatide for osteoporotic vertebral fractures: A phase I/IIa study
- Authors
- Shim, JeongHyun; Kim, Kyoung-Tae; Kim, Kwang Gi; Choi, Un-Yong; Kyung, Jae Won; Sohn, Seil; Lim, Sang Heon; Choi, Hyemin; Ahn, Tae-Keun; Choi, Hye Jeong; Shin, Dong-Eun; Han, Inbo
- Issue Date
- Apr-2021
- Publisher
- WILEY
- Keywords
- mesenchymal stem cells; osteoporosis; teriparatide; vertebral compression fracture; Wharton' s jelly
- Citation
- Stem Cells Translational Medicine, v.10, no.4, pp.554 - 567
- Journal Title
- Stem Cells Translational Medicine
- Volume
- 10
- Number
- 4
- Start Page
- 554
- End Page
- 567
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/80568
- DOI
- 10.1002/sctm.20-0308
- ISSN
- 2157-6564
- 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
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