Morning All!,
Just a bit of an update from the Dr Collins blog this morning with regards to the Eli Lilly Treatment clinical trial (which I still think is pretty substantial news regarding the use of natural body cells to fight the disease instead of "drugs"!)
"Among the most exciting approaches are monoclonal antibodies (mAbs), which are biologic drugs derived from neutralizing antibodies isolated from people who’ve survived COVID-19. This week, the partnership launched two trials (one for COVID-19 inpatients, the other for COVID-19 outpatients) of a mAB called LY-CoV555, which was developed by Eli Lilly and Company, Indianapolis, IN. It was discovered by Lilly’s development partner AbCellera Biologics Inc. Vancouver, Canada, in collaboration with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). In addition to the support from ACTIV, both of the newly launched studies also receive support for Operation Warp Speed, the government’s multi-agency effort against COVID-19.
LY-CoV555 was derived from the immune cells of one of the very first survivors of COVID-19 in the United States. It targets the spike protein on the surface of SARS-CoV-2, blocking it from attaching to human cells.
The first trial, which will look at both the safety and efficacy of the mAb for treating COVID-19, will involve about 300 individuals with mild to moderate COVID-19 who are hospitalized at facilities that are part of existing clinical trial networks. These volunteers will receive either an intravenous infusion of LY-CoV555 or a placebo solution. Five days later, their condition will be evaluated. If the initial data indicate that LY-CoV555 is safe and effective, the trial will transition immediately—and seamlessly—to enrolling an additional 700 participants with COVID-19, including some who are severely ill.
The second trial, which will evaluate how LY-CoV555 affects the early course of COVID-19, will involve 220 individuals with mild to moderate COVID-19 who don’t need to be hospitalized. In this study, participants will randomly receive either an intravenous infusion of LY-CoV555 or a placebo solution, and will be carefully monitored over the next 28 days. If the data indicate that LY-CoV555 is safe and shortens the course of COVID-19, the trial will then enroll an additional 1,780 outpatient volunteers and transition to a study that will more broadly evaluate its effectiveness.
Both trials are later expected to expand to include other experimental therapies under the same master study protocol. Master protocols allow coordinated and efficient evaluation of multiple investigational agents at multiple sites as the agents become available. These protocols are designed with a flexible, rapidly responsive framework to identify interventions that work, while reducing administrative burden and cost.In addition, Lilly this week started a separate large-scale safety and efficacy trial to see if LY-CoV555 can be used to prevent COVID-19 in high-risk residents and staff at long-term care facilities. The study isn’t part of ACTIV."
As another reminder, here is the NIH Article on Interaction between Mesenchymal Stem Cells and B-Cells. Its not a puff piece. I see it as a very respectable neutral study showing both good and bad effects. As mentioned here previously, in studies it has shown that convalescent plasma also works well with MSC's. I can see why natural body cells have the best chance to fight a virus and in my opinion why we have a great fighting chance to treat this thing.
From the NIH Article
The interaction between MSCs and B-cells is sophisticated; diverse culture environments and types of cells affect the immunoregulation of B-cells by MSCs. In purified B-cell–MSC environments, MSCs regulate B-cell functions via soluble factors (Table 1) and cell–cell contact. We found that the soluble factors related to the immunoregulation of B-cells can be divide into two subtypes based on their function: pro-inflammatory and anti-inflammatory. Membrane vesicles, CCL2, B7-H1, VEGF, C3, GAL-9, and IDO are anti-inflammatory, whereas BAFF, PGE2, and APRIL are pro-inflammatory. In the co-culture systems listed above, the B-cell stimulators and the ratio between MSCs and B-cells were varied, yet MSCs were still able to modulate the functions of B-cells. Therefore, this process likely depends on paracrine signaling [96]. We hypothesize that MSCs are influenced by diverse stimulators in co-culture systems, which can lead to the distinct immune regulation of B-cells by MSCs observed in different experimental setups
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