NCT05082831

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

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 Alone

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Histogen · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

HST003 belongs to a new class of natural human matrix components geared toward cartilage regeneration. The bulk of this purified hECM is structural collagens, actin, and tubulin, but it also contains structural glycoproteins. HST003 is a physiological scaffold to support the infiltration of autologous mesenchymal stem cells to regenerate cartilage, and preferably hyaline cartilage. The safety of HST003 is supported by preclinical data, which show that hECM is nontoxic, noncytotoxic, nongenotoxic, non-irritant, non-sensitizing, and non-pyrogenic. The preclinical data summary is contained in the Investigator Brochure (IB) including biocompatibility data. A description of the manufacture, chemistry, efficacy, and preclinical safety of HST003 is also provided in the IB. The comparator in this study will be microfracture surgery alone, the current standard of care. Microfracture treatment is a single-stage arthroscopic procedure that is minimally invasive and has limited surgical morbidity (see surgical ICF for standard microfracture).

Conditions

• Articular Cartilage Disorder of Knee
• Cartilage Damage
• Microfractures

Interventions

Type	Name	Description
BIOLOGICAL	microfracture surgery + HST003	This is an Intervention Model where all patients who are identified/confirmed candidates for microfracture surgery will be enrolled to receive the microfracture surgery (standard of care). Ten (10) patients will be randomized to receive the study intervention (HST003). HST003 will be injected into the microfracture defects (interstices) and fill the remainder of the defect to the cartilage margin following surgery. The primary purpose of the study is to compare the two groups: microfracture surgery + HST003 as compared to the microfracture surgery only group.

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-12-16
• Completion: 2023-01-16
• First posted: 2021-10-19
• Last updated: 2023-01-19

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study