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Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage

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Contents

Study summaryTimelineTable: Further ResourcesReferences
clinicaltrials.gov/study/NCT05082831
Is a
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Clinical study
1

Clinical Study attributes

NCT Number
NCT050828311
Trial Recruitment Size
11
Trial Sponsor
Histogen
Histogen
1
Clinical Trial Start Date
November 15, 2021
1
Primary Completion Date
December 16, 2022
1
Study Completion Date
January 16, 2023
1
Clinical Trial Study Type
Interventional1
Interventional Trial Purpose
Treatment1
Intervention Type
Biological1
Intervention Name
microfracture surgery + HST0031
Interventional Trial Phase
Phase 11
Official Name
A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Human Extracellular Matrix Implanted in the Bone Interstices & the Cartilage Defect Following Arthroscopic Microfracture Surgery in the Knee,in Comparison to Microfracture Surgery Alone1
Last Updated
January 19, 2023
1
Allocation Type
Randomized1
Intervention Model
Parallel Assignment1
Masking Type
Single1
Masked Party
Participant1
Study summary

HST003 is a human extracellular matrix designed for injection into the subchondral bone following microfracture surgery by an injection into the interstices created by the surgical awl and filling the full defect to help restore-regenerate hyaline cartilage to a pre-injury state. In this Phase 1/2 clinical trial, we will be addressing the knee joint in conjunction with microfracture surgery. HST003 is human extracellular matrix secreted by human dermal fibroblasts under hypoxic conditions. The various matrix proteins produce a combination structural scaffold in addition to the natural secreted glycoproteins such as lubricin, fibronectin, laminins, hyaluronic acid, and collagens - all critical components of cartilage, particularly hyaline cartilage. This Phase 1/2 study will help design additional studies to support FDA approval for the use of HST003 in focal cartilage defects in the knee resulting from recent traumatic injury.

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