Sep 23, 2020 · MultiStem is the only cell therapy program for ARDS that has both Fast Track and RMAT designation from the FDA. Also, the Company’s partner in Japan, HEALIOS K.K. (Healios), is anticipating the completion of enrollment in its orphan designated ARDS clinical trial (ONE-BRIDGE) by the end of this year.
...MultiStem therapy in patients with moderate to severe acute respiratory distress syndrome or There are no FDA-approved medicines for the treatment of ARDS. Athersys plans to open the first...
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Jan 01, 2008 · Each MultiStem dose was injected intravenously at a dose of 2.5 million cells/rat (c. 12.5 million cells/kg). Rats were evaluated for 5 weeks and killed on day 37. MultiStem test article. The Lewis rat MultiStem line, lrBMC9.1 , was chosen as the test article for this study. Cells were used from two frozen MultiStem banks, generated by two ...
Listen to Multistem – A Stable, Off-the Shelf Regenerative Medicine Has Demonstrated Promise In Treating Patients With Acute Respiratory Distress Syndrome Or ARDS and fifty-three more episodes by Cell Culture Dish Podcast, free!
Apr 13, 2020 · The Company plans to open the first clinical sites for recruitment of this MACOVIA (MultiStem Administration for COVID-19 Induced ARDS) study this quarter. According to the World Health Organization (WHO) and other recent clinical and epidemiological data, ARDS is the leading cause of death among COVID-19 infected patients.
Dec 23, 2020 · In contrast, one MultiStem dose contains about eight times as many, or 1.2 billion, cells. 3) Timing of dose administration: In its COVID-19 ARDS study, Mesoblast administered its doses within 72 hours of the ARDs diagnosis whereas in the MACOVIA study, Athersys will dose patients sooner, within 48 hours.
Early-stage study results from the multi-center MUST-ARDS trial show the ex-vivo adult progenitor cell-expanding therapy is capable of improving 28-day...
Credit: Pasteur Institut Pasteur/CNR for Respiratory Viruses at the Institut Pasteur. Athersys' core product is called MultiStem, which is an allogeneic marrow-derived cellular drug thought to reduce...
Candidate: MultiStem® for acute respiratory distress syndrome (ARDS). Type: Adult-derived "off-the-shelf" therapy under development for several neurological and cardiovascular diseases, as well as...
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  • Animals received MultiStem in a single dose of 12.5 million cells/kg on day 2 after HSCT or in five infusions at this dose on days 2, 9, 16, 23 and 30. Controls received phosphate-buffered saline injections and all animals were killed on day 37.
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Within the prospectively defined group of patients with more severe ARDS, MultiStem treatment was associated with a markedly greater rate of survival and progression to functional independence at one year (i.e., self-care); and

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Apr 15, 2020 · About MultiStem ® MultiStem ® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety...

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MultiStem is the only cell therapy program for acute respiratory distress syndrome (ARDS) that has both Fast Track and RMAT designation from the FDA.

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Multistem was designated “Highly Relevant” as a Potential Therapy for COVID-19 by BARDA. . The only cell therapy treatment for ARDS that has both Fast Track and RMAT designations.. It has the potential to make a significant improvement in COVID-19 ARDS patients.

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Early-stage study results from the multi-center MUST-ARDS trial show the ex-vivo adult progenitor cell-expanding therapy is capable of improving 28-day...

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Dec 21, 2020 · Athersys is also evaluating MultiStem in other studies, including a phase 2/3 study targeting patients with COVID-19 induced acute respiratory distress syndrome (ARDS) and a late-stage study ...

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Lower inflammatory cytokine levels at day-7 in the MultiStem grouprelative to the placebo group, including IFNg, IL-6 and IL-1b among others,suggest the potential for MultiStem treatment to abate the severe inflammatoryresponse associated with ARDS; and MultiStem treatment was well tolerated inthis very sick ARDS patient population, with no serious adverse events relatedto administration through one year of follow-up.”

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Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) (NCT03042143) Umbilical cord Cells isolated based on cell surface CD362 expression Early passage No A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome (MUST-ARDS) (NCT02611609) Bone marrow Plastic adherent Unknown No

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Introduction Bone marrow-derived multipotent adult progenitor cells (MAPCs) are adult allogeneic adherent stem cells currently investigated clinically for use in acute respiratory distress syndrome (ARDS). To date, there is no agreement on which is the best method for stem cells delivery in ARDS.

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In an interview with MD Magazine® while at the American Thoracic Society (ATS) 2019 International Meeting in Dallas, TX, MUST-ARDS author Dr. Geoff Bellingan, an intensive care consultant for University College London Hospital, discussed the pathway to a phase 3 MultiStem Cell Therapy trial for patients with ARDS—and how it’ll build on the ...

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Athersys Receives FDA Fast Track Designation For Its MultiStem Program For Acute Respiratory Distress Syndrome Cboe - Market News Story Benzinga Newsdesk 5/14/2019 5:11:54 AM

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In April 2020 we initiated the MACOVIA study to evaluate MultiStem cell therapy for the treatment of COVID-19 induced ARDS patients. This trial is a multicenter study with an open-label, single active treatment arm for cohort 1 followed by a double-blind, randomized, placebo-controlled Phase 2/3 portion.

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May 12, 2020 · Bellingan G , Jacono F , Barnard-Smith J et al. Primary analysis of a Phase I/IIstudy to assess MultiStem cell therapy, a regenerative advanced therapy medicinal product (ATMP), in acute respiratory distress syndrome (MUST-ARDS).

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MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) (MACoVIA) Official Title: A Phase 2/3 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease (COVID-19) Secondary IDs:

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Within the prospectively defined group of patients with more severe ARDS, MultiStem treatment was associated with a markedly greater rate of survival and progression to functional independence at one year (i.e., self-care); and

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Mar 20, 2020 · Currently, Athersys is preparing for a Phase III trial in ARDS patients and is also conducting a Phase III study in stroke patients. MultiStem is a stem cell therapy derived from multipotent adult progenitor cells from the bone marrow of young, healthy donors.

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* fda authorizes athersys to initiate a pivotal clinical trial evaluating multistem® cell therapy in patients with covid-19 induced acute respiratory distress syndrome

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MultiStem is the only cell therapy program for ARDS that has both Fast Track and RMAT designation from the FDA. Also, the Company’s partner in Japan, HEALIOS K.K. (Healios), is anticipating the completion of 1 enrollment in its orphan designated ARDS clinical trial (ONE-BRIDGE) by the end of this year.

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Jan 23, 2019 · CLEVELAND, Jan. 23, 2019 (GLOBE NEWSWIRE) -- Athersys, Inc. (NASDAQ: ATHX) announced today summary results from its exploratory clinical study of the intravenous administration of MultiStem® cell therapy to treat patients who are suffering from acute respiratory distress syndrome (ARDS).

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ARDS. Biological: MultiStem Biological: Placebo. A Phase 2/3 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS)...

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Apr 14, 2020 · The federal government has given Cleveland-based Athersys Inc. (Nasdaq: ATHX) the go-ahead for a clinical trial to test the company's MultiStem cell therapy in patients with acute respiratory distress syndrome (ARDS) induced by the novel coronavirus.

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May 07, 2020 · The first of these, the MACOVIA study for treating patients suffering from COVID-19 induced ARDS and related complications, represents our second pivotal trial, alongside our ongoing MASTERS-2 trial evaluating the administration of MultiStem for treating ischemic stroke.

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Dec 23, 2020 · In contrast, one MultiStem dose contains about eight times as many, or 1.2 billion, cells. 3) Timing of dose administration: In its COVID-19 ARDS study, Mesoblast administered its doses within 72 hours of the ARDs diagnosis whereas in the MACOVIA study, Athersys will dose patients sooner, within 48 hours.

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Within the prospectively defined group of patients with more severe ARDS, MultiStem treatment was associated with a markedly greater rate of survival and progression to functional independence at one year (i.e., self-care); and

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Also known as: Respiratory Distress Syndrome, Acute / ARDS / Acute Respiratory Distress Syndrome / Distress respiratory syndrome adults / Respiratory distress syndrome / Respiratory distress syndrome (& [hyaline membrane disease]) / Shock lung / Acute respiratory distress syndrome (disorder) / Syndrome adult respiratory distress / Syndrome respiratory distress adult / Respiratory distress ...

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Apr 15, 2020 · MultiStem ® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapy’s potential for ...

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pay $10m to license the development of MultiStem for acute respiratory distress syndrome (ARDS) and an undisclosed orthopedic application if the forthcoming Phase II ARDS trial is successful.

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Jan 16 · PI/II study to assess Multistem® cell therapy in patients with acute respiratory distress syndrome starts (MUST-ARDS; NCT02611609). The double-blind, open, parallel, prospective, randomised trial will enrolled 36 patients in the US and the UK.

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In Tokyo, the stem cell product HLCM051 (MultiStem ®) is being used for new treatment of acute respiratory distress syndrome (ARDS) and ischemic stroke. Japanese biotechnology company Healios continued to make progress in the phase 2 clinical study in Japan to confirm the safety and effectiveness of HLCM051 in patients with pneumonia-induced ...

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Dec 21, 2020 · MultiStem cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as...
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Apr 13, 2020 · In a Phase 1/2 study of MultiStem therapy for the treatment of ARDS, favorable tolerability data and meaningful potential benefits in mortality, ventilator-free days and ICU-free days observed Company plans to initiate a Phase 2/3 pivotal study in patients with COVID-19 induced ARDS this quarter Advancement of key Athersys program with FDA Fast Track designation for the treatment of ARDS ... Completion of enrollment in MUST-ARDS trial –and successful results .. Fast Track and RMAT designation for ARDS program .. Healios’ advancement of the ONE-BRIDGE study for ARDS and Orphan designation from PMDA .. BARDA and CoronaWatch Task Force designation for MultiStem as a “Highly Relevant” therapeutic for COVID-19


cell product MultiStem® to treat ischemic stroke in Japan. Further, in June 2018 Healios and Athersys expanded their collaboration broadly, and as part of this expansion Healios acquired the development and distribution licenses to use MultiStem to treat ARDS in Japan.