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Vericel Corp (VCEL)
NASDAQ:VCEL
Microfracture, Maci
Articular Cartilage Defect, Chondral Defect, Osteochondritis Dissecans (Ocd), Articular Cartilage Disorder Of Knee
Phase III
Recruiting
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Apr 04, 2018
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Ixmyelocel-T
Ischemic Dilated Cardiomyopathy (Idcm)
Phase II
Completed
An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)
Aug 20, 2012
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Ixmyelocel-T
Critical Limb Ischemia
Phase III
Completed
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
Nov 30, 2011
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Ixmyelocel-T, Vehicle Control
Dilated Cardiomyopathy
Phase II
Completed
Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC]) Treatment in Patients With Heart Failure Due to Dilated Cardiomyopathy
Nov 25, 2009
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Bone Repair Cells (Brcs), Autologous Bone Graft
Single Level Posterolateral Spinal Fusion
Phase I/II
Terminated
Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion
Nov 24, 2008
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Standard of Care, Ixmyelocel-T
Dilated Cardiomyopathy
Phase II
Completed
Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)
Oct 02, 2008
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Autologous Cultured Chondrocytes On Porcine Collagen Membrane, Microfracture
Articular Cartilage Defect
Phase III
Completed
Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee
Jul 17, 2008
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Ixmyelocel-T, Standard Of Care Only
Osteonecrosis
Phase III
Completed
Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head
Jul 20, 2007
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Ixmyelocel-T
Peripheral Arterial Disease
Phase II
Completed
Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
Apr 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 Vericel Corp (VCEL) have in its pipeline
VCEL is currently developing the following drugs: Autologous Cultured Chondrocytes On Porcine Collagen Membrane, Bone Marrow Stimulation, Microfracture, Maci, Ixmyelocel-T. These drug candidates are in various stages of clinical development as the company works toward FDA approval.