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Authors
Qu, Wenchun
Yan, Dan
Durand, Nisha C.
Wang, Zhen
Lehman, Vance L.
Osborne, Michael D.
Stone, Jeffrey A.
Miller, David A.
Gupta, Sahil
Engelberg-Cook, Erica
Wiest, Elani F.
Witter, Drew M.
Siebenaler, Kathryn A.
Quiñones-Hinojosa, Alfredo
Zubair, Abba C.
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04410731 at ClinicalTrials.govDocuments that mention this clinical trial
Intra-articular delivery of allogeneic bone marrow derived mesenchymal stromal cells (BM-MSCs) for painful lumbar facet arthropathy: a phase I clinical trial
https://doi.org/10.1186/s13287-025-04674-y
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Funding
Funding for this research was provided by:
Gerstner Family Foundation (Gerstner Family Foundation)
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Article History
Received: 20 May 2025
Accepted: 12 September 2025
First Online: 30 October 2025
Declarations
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: W.Q. is supported by Louis V. Gerstner, Jr. Fund at Vanguard Charitable and serves as the Jorge and Leslie Bacardi Associate Director of the Mayo Clinic Center for Regenerative Biotherapeutics in Florida, as well as at the Tissue Engineering Advisory Group for the Alliance for Regenerative Medicine. A.Z. is supported by Skoll Foundation, DeSantis Funds for Cancer Research, and NASA Space Research. J.S. serves as the president of Florida Radiological Society Education Foundation. A.Q. is the founder of DOME Therapeutics and Aqualux. A.Q. is supported by the William J. and Charles H. Mayo Professorship, the Mayo Clinic Clinician Investigator award, the Florida Department of Health Cancer Research Chair Fund, The Monica Flynn Jacoby Endowed Chair, the Richard and Lauralee Uihlein Neurooncology support, as well as the National Institutes of Health (R01CA284268, R01NS129671, R01CA282451). The other authors indicated no conflicts of interest.
: This study adhered to the principles outlined in the Declaration of Helsinki and was approved by the Institutional Review Board(IRB) of Mayo Clinic, Florida, USA in April 2020 (Study title: “CELLKINE: Phase I Study Evaluating the Safety and Feasibility of Allogeneic, Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells in Subjects with Painful Lumbar Facet Joint Arthropathies”, IRB#: 20–000330). The clinical trial was registered on ClinicalTrials.gov (Identifier: NCT04410731). Written informed consent was obtained from all participants prior to their enrollment in the study. The Human Cell Therapy Laboratory (HCTL) confirmed that human bone marrow collection for MSC manufacturing was conducted under Mayo Clinic IRB approval, with written informed consent obtained from the donor.
