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Provacel

Phase 1

Myocardial Infarction | Monoclonal antibody | Cardiovascular |Mesoblast Limited|Last Updated: Mar 10, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Provacel · 1 trial · 1 indication

Phase 1 1
NCT00114452Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial InfarctionMyocardial Infarction
COMPLETED60 Analytics
PHASE1COMPLETED
Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction
Myocardial Infarction
NCT0011445260
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Study Endpoints

Primary Endpoints

Comparison of treatment adverse event rates between the 0.5, 1.6 and 5.0 million mesenchymal stem cells per kilogram dose cohorts and placebo groups.
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Provacel: Cohort 1ACTIVE_COMPARATORex vivo cultured adult mesenchymal stem cells
Provacel: Cohort 2ACTIVE_COMPARATORex vivo cultured adult mesenchymal stem cells
Provacel: Cohort 3ACTIVE_COMPARATORex vivo cultured adult mesenchymal stem cells
Provacel: Cohort 4ACTIVE_COMPARATORex vivo cultured adult mesenchymal stem cells
PlaceboPLACEBO_COMPARATORex vivo cultured adult mesenchymal stem cells

Interventions

NameTypeDescription
ProvacelBIOLOGICALex vivo cultured adult mesenchymal stem cells
PlaceboBIOLOGICALPlacebo
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Eligibility Criteria

Age Range21 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Male or female between 21 and 85 years old * First heart attack within 1 to 10 days Exclusion Criteria: * Positive for HIV 1 and 2 * Previous heart attack * Pacemaker or other device * Pregnant or breastfeeding * Allergic to cow or pig derived products * Previous bone marrow...

Countries:United States
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Frequently asked questions about Provacel

What is Provacel used for?

Provacel is an investigational therapy being studied for the treatment of myocardial infarction, commonly known as a heart attack. It is a monoclonal antibody developed by Mesoblast Limited. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does Provacel target?

Provacel is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential role in treating myocardial infarction, though the exact mechanism of action is not publicly detailed.

Who makes Provacel?

Provacel is being developed by Mesoblast Limited, a biopharmaceutical company listed on the stock exchange under the ticker symbol MESO. Mesoblast is conducting clinical research to evaluate the safety and efficacy of Provacel in patients with myocardial infarction.

What phase is Provacel in?

Provacel is currently in Phase 1 clinical development. It has completed one Phase 1 trial, which was a safety study in patients with acute myocardial infarction. The drug remains investigational and has not yet received regulatory approval for any indication.

What clinical trials is Provacel in?

Provacel has been studied in one completed Phase 1 clinical trial with the identifier NCT00114452. This trial, titled 'Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction,' enrolled 60 participants in the United States. The study was randomized, double-blind, and placebo-controlled.

Is Provacel the same as adult mesenchymal stem cells?

Provacel is a monoclonal antibody, while the clinical trial NCT00114452 investigated adult mesenchymal stem cells. These are distinct therapeutic approaches. The trial title references the stem cells, but Provacel itself is a different modality, and no alternative names for Provacel have been disclosed.