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Humacyte (HUMA)
NASDAQ:HUMA
Acellular Tissue Engineered Vessel (Atev), Avf
End Stage Renal Disease (Esrd)
Phase III
Recruiting
To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
Apr 28, 2023
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Human Acellular Vessel (Hav), Arteriovenous Fistula (Avf), Hemodialysis
Hemodialysis, End Stage Renal Disease, Renal Failure, Vascular Access
Phase III
Active Not Recruiting
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
Jun 08, 2017
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Human Acellular Vessel (Hav)
Peripheral Artery Disease
Phase II
Completed
Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD
Aug 25, 2016
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Human Acellular Vessel (Hav), Eptfe Graft
Hemodialysis, End Stage Renal Disease, Renal Failure, Vascular Access
Phase III
Completed
Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
Dec 29, 2015
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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 Humacyte (HUMA) have in its pipeline
HUMA is currently developing the following drugs: Acellular Tissue Engineered Vessel (Atev), Avf, Human Acellular Vessel (Hav), Arteriovenous Fistula (Avf), Hemodialysis, Human Acellular Vessel (Hav). These drug candidates are in various stages of clinical development as the company works toward FDA approval.