A few years ago the researchers were outlining the next 10 steps towards spinal cord injury repair. Things like ABChondroitonase and remyelinators were bandied about.
Now they are talking Pixie Dust (yes, really). 10 years ago it was stem cell and gene therapy. Without increased funding (notlikely) it will not happen during our careers. SO we need to do what we can with what we got and hope that the small promise of better meds and improved robotics will allow our patients better functional outcomes.
The concepts are 30-50 years old, the science will catch up to the science fiction in the next 10 years, then sorting the bugs out of all of these things will take another 20 to allow it to be used in Medicine.
http://www.ninds.nih.gov/disorders/sci/detail_sci.htm#106283233
Building the Real Iron Man
Intravenous Infusion of Auto Serum-expanded Autologous Mesenchymal Stem Cells in Spinal Cord Injury Patients: 13 Case Series
Author links open overlay panelOsamuHonmouabh1ToshihikoYama****ac1TomonoriMoritaacTsutomuOshigiriacRyosukeHirotaacSatoshiIyamadJunjiKatoeYuichiSasakiafSumioIshiaifYoichi M.ItogAiNamiokaaTakahiroNamiokaaMasahitoNakazakiaYukoKataoka-SasakiabRieOnoderaaShinichiOkaabMasanoriSasakiabgStephen G.WaxmanhJeffery D.Kocsish
https://doi.org/10.1016/j.clineuro.2021.106565Get rights and content
Under a Creative Commons licenseopen access
Highlights
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We report a series of SCI patients treated with intravenous infusion of MSCs.
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Autologous MSCs cultured with auto-serum were used.
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The results document observed functional changes and provide support for the safety and tolerability of this procedure.
Abstract
Background
Although spinal cord injury (SCI) is a major cause of disability, current therapeutic options remain limited. Recent progress in cellular therapy with mesenchymal stem cells (MSCs) has provided improved function in animal models of SCI. We investigated the safety and feasibility of intravenous infusion of MSCs for SCI patients and assessed functional status after MSC infusion.
Methods
In this phase 2 study of intravenous infusion of autologous MSCs cultured in auto-serum, a single infusion of MSCs under Good Manufacturing Practice (GMP) production was delivered in 13 SCI patients. In addition to assessing feasibility and safety, neurological function was assessed using the American Spinal Injury Association Impairment Scale (ASIA), International Standards for Neurological and Functional Classification of Spinal Cord (ISCSCI-92). Ability of daily living was assessed using Spinal Cord Independence Measure (SCIM-III). The study protocol was based on advice provided by the Pharmaceuticals and Medical Devices Agency in Japan. The trial was registered with the Japan Medical Association (JMA-IIA00154).
Results
No serious adverse events were associated with MSC injection. There was neurologic improvement based on ASIA grade in 12 of the 13 patients at six months post-MSC infusion. Five of six patients classified as ASIA A prior to MSC infusion improved to ASIA B (3/6) or ASIA C (2/6), two ASIA B patients improved to ASIA C (1/2) or ASIA D (1/2), five ASIA C patients improved and reached a functional status of ASIA D (5/5). Notably, improvement from ASIA C to ASIA D was observed one day following MSC infusion for all five patients. Assessment of both ISCSCI-92, SCIM-III also demonstrated functional improvements at six months after MSC infusion, compared to the scores prior to MSC infusion in all patients.
Conclusion
While we emphasize that this study was unblinded, and does not exclude placebo effects or a contribution of endogenous recovery or observer bias, our observations provide evidence supporting the feasibility, safety and functional improvements of infused MSCs into patients with SCI.
Keywords
mesenchymal stem cellcase seriesclinical trials
