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Prochymal
Crohn's Disease
Phase III
Completed
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
Nov 02, 2010
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Prochymal
Myocardial Infarction
Phase II
Completed
Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
Apr 07, 2009
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Prochymal
Diabetes Mellitus, Insulin-Dependent, Type 1 Diabetes Mellitus, Type 1 Diabetes, Juvenile Diabetes
Phase II
Completed
PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)
Jun 02, 2008
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Prochymal
Pulmonary Disease, Chronic Obstructive, Chronic Bronchitis, Pulmonary Emphysema
Phase II
Completed
PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
May 21, 2008
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Prochymal Adult Human Mesenchymal Stem Cells
Crohn's Disease
Phase III
Completed
Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
Oct 11, 2007
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Prochymal
Crohn's Disease
Phase III
Completed
Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
May 30, 2007
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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 Mesoblast Ltd (MESO) have in its pipeline
MESO is currently developing the following drugs: Saline, Rexlemestrocel-L + Ha Mixture, Prochymal, Prochymal. These drug candidates are in various stages of clinical development as the company works toward FDA approval.