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Mesoblast phase 2

Amirdelfan, K., Bae, H., McJunkin, T., DePalma, M., Kim, K., Beckworth, W. J., Ghiselli, G., Bainbridge, J. S., Dryer, R., Deer, T. R., & Brown, R. D. (2021). Allogeneic mesenchymal precursor cells treatment for chronic low back pain associated with degenerative disc disease: a prospective randomized, placebo-controlled 36-month study of safety and efficacy. The spine journal : official journal of the North American Spine Society, 21(2), 212–230.

https://doi.org/10.1016/j.spinee.2020.10.004

Mesoblast phase 3 part 1

Beall, D. P., Bae, H. W., DePalma, M. J., Amirdelfan, K., Tavel, E., Davis, T. T., Bainbridge, J. S., Weil, A., Beckworth, W., Kim, K., Yuan, P., Gupta, P. B., Wang, E., Goodman, B. S., Reeves, R., Furman, M. B., Mekhail, N., Nunez, D., DiMuro, M., … Brown, R. D. (n.d.). Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells With and Without Hyaluronic Acid for Treatment of Chronic Low Back Pain: A Prospective, Randomized, Double Blind, Concurrent-Controlled 36-Month Study. The Spine Journal.

https://doi.org/10.1016/j.spinee.2025.03.015

Discgenics

Gornet, M. F., Beall, D. P., Davis, T. T., Coric, D., LaBagnara, M., Krull, A., DePalma, M. J., Hsieh, P. C., Mallempati, S., Schranck, F. W., Kelly, C., & Foley, K. T. (2024). Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration-Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial. International journal of spine surgery, 18(3), 237–248.

https://doi.org/10.14444/8609

ViaDisc

Costandi, S., Beall, D. P., Davis, T. T., Amirdelfan, K., Naidu, R. K., DePalma, M. J., … Mekhail, N. (2025). Durability of Supplemental Nucleus Pulposus Allograft in Patients with Lumbar Discogenic Pain. Journal of Pain Research, 18, 1901–1908.

https://doi.org/10.2147/JPR.S516571

Biostat

Way Yin, Kevin Pauza, Wayne J. Olan, Jeff F. Doerzbacher, Kevin J. Thorne, Intradiscal Injection of Fibrin Sealant for the Treatment of Symptomatic Lumbar Internal Disc Disruption: Results of a Prospective Multicenter Pilot Study with 24-Month Follow-Up, Pain Medicine, Volume 15, Issue 1, January 2014, Pages 16–31,

https://doi.org/10.1111/pme.12249

VAST abstract

Beall, D. P., Davis, T., DePalma, M. J., Amirdelfan, K., Yoon, E. S., Wilson, G. L., Bishop, R., Tally, W. C., Gershon, S. L., Lorio, M. P., Meisel, H. J., Langhorst, M., Ganey, T., & Hunter, C. W. (2021). Viable Disc Tissue Allograft Supplementation; One- and Two-level Treatment of Degenerated Intervertebral Discs in Patients with Chronic Discogenic Low Back Pain: One Year Results of the VAST Randomized Controlled Trial. Pain physician, 24(6), 465–477.

Tissue Gene Phase 2

Cherian, J. J., Parvizi, J., Bramlet, D., Lee, K. H., Romness, D. W., & Mont, M. A. (2015). Preliminary results of a phase II randomized study to determine the efficacy and safety of genetically engineered allogeneic human chondrocytes expressing TGF-β1 in patients with grade 3 chronic degenerative joint disease of the knee. Osteoarthritis and cartilage, 23(12), 2109–2118.

https://doi.org/10.1016/j.joca.2015.06.019

Smart FR Ablation

Fischgrund, J. S., Rhyne, A., Franke, J., Sasso, R., Kitchel, S., Bae, H., Yeung, C., Truumees, E., Schaufele, M., Yuan, P., Vajkoczy, P., Depalma, M., Anderson, D. G., Thibodeau, L., & Meyer, B. (2019). Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study. International journal of spine surgery, 13(2), 110–119.

https://doi.org/10.14444/6015

Bioness Nerve Stimulator

Regnier, S. M., Chen, J., Gabriel, R. A., & Chakravarthy, K. V. (2021). A review of the StimRouter® peripheral neuromodulation system for chronic pain management. Pain management, 11(3), 227–236.

https://doi.org/10.2217/pmt-2020-0042

Accurate Axium Nerve Stim

Deer, T. R., Levy, R. M., Kramer, J., Poree, L., Amirdelfan, K., Grigsby, E., Staats, P., Burton, A. W., Burgher, A. H., Obray, J., Scowcroft, J., Golovac, S., Kapural, L., Paicius, R., Kim, C., Pope, J., Yearwood, T., Samuel, S., McRoberts, W. P., Cassim, H., … Mekhail, N. (2017). Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain, 158(4), 669–681.

https://doi.org/10.1097/j.pain.0000000000000814

Coolief Study

Davis, T., Loudermilk, E., DePalma, M., Hunter, C., Lindley, D., Patel, N., Choi, D., Soloman, M., Gupta, A., Desai, M., Buvanendran, A., & Kapural, L. (2018). Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Regional anesthesia and pain medicine, 43(1), 84–91.

https://doi.org/10.1097/AAP.0000000000000690

Relief Trial

Desai, M. J., Raju, T., Ung, C., Arulkumar, S., Kapural, L., Gupta, M., Amirdelfan, K., Rosenfeld, D., Calodney, A., Sayed, D., Antony, A., Li, S., Naidu, R., Ackerman, J., Ball, R., Fishman, M., Staats, P., Heit, G., Kottalgi, S., & Makous, J. (2024). Composite treatment response from a prospective, multi-center study (US-nPower) evaluating a miniature spinal cord stimulator for the management of chronic, intractable pain. Pain Physician, 27, E881–E889.

https://www.painphysicianjournal.com/current/pdf?article=NjI5MQ%3D%3D&journal=141

Xalud

Grigsby, E., et al. (2021). XT-150: A novel immunomodulatory gene therapy for osteoarthritis pain in phase 2b development. Osteoarthritis and Cartilage, 29(Suppl 1), S12.

https://doi.org/10.1016/j.joca.2021.02.021

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