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Healios KK (JP:4593)
:4593
Multistem
Trauma, Adult Stem Cells
Phase II
Recruiting
MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome
Aug 26, 2020
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Multistem
Ards
Phase II/III
Unknown
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
Apr 27, 2020
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Hlcm051
Respiratory Distress Syndrome, Adult
Phase II
Completed
Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome
Jan 08, 2019
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Multistem
Ischemic Stroke
Phase III
Unknown
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study
May 23, 2018
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Hlcm051
Stroke, Acute
Phase II/III
Completed
Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements
Nov 07, 2016
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Multistem
Acute Respiratory Distress Syndrome
Phase I/II
Completed
A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome
Nov 18, 2015
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Sham, Ami Multistem Cells
Heart Attack, Nstemi
Phase II
Terminated
A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
Oct 24, 2014
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Multistem
Ischemic Stroke
Phase II
Completed
Study to Examine the Effects of MultiStem in Ischemic Stroke
Sep 15, 2011
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Multistem Low Dose, Multistem High Dose
Colitis, Ulcerative
Phase II
Completed
A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
Nov 10, 2010
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Healios KK (4593) have in its pipeline
4593 is currently developing the following drugs: Multistem, Multistem, Hlcm051. These drug candidates are in various stages of clinical development as the company works toward FDA approval.