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Extracellular Matrix

microfracture surgery + HST003 for Microfractures (hECM;HST003 Trial)

Phase 1
Waitlist Available
Research Sponsored by Histogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 168 (week 24, visit 8) and day 365 (week 52, visit 9)
Awards & highlights

hECM;HST003 Trial Summary

This trial is designed to test the safety and effectiveness of HST003, a human extracellular matrix designed to help restore-regenerate hyaline cartilage, in conjunction with microfracture surgery.

Eligible Conditions
  • Microfractures
  • Osteoarthritis
  • Cartilage Damage

hECM;HST003 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 168 (week 24, visit 8) and day 365 (week 52, visit 9)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 168 (week 24, visit 8) and day 365 (week 52, visit 9) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of joint pain equal to or lesser than microfracture alone, and equal or greater function, as measured using the KOOS (Knee Injury and Osteoarthritis Outcome Score) questionnaire
Assessment of joint pain equal to or lesser than microfracture alone, and equal or greater function, as measured using the Visual Analog Scale (VAS) questionnaire between baseline and month 6
Assessment of joint pain equal to or lesser than microfracture alone, and equal or greater function, as measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire between baseline and month 6
+1 more
Secondary outcome measures
An independent central radiologist from the Image Analysis Group (IAG) will blindly read the MRIs evaluate cartilage quality within the repaired defects.
An independent central radiology reviewer from the Image Analysis Group (IAG) will read the MRIs, blinded. The reviewer's scores will be used in the efficacy assessment.
Investigator assessment of functional Range of Motion (ROM) including overall strength in the knee
+2 more

hECM;HST003 Trial Design

2Treatment groups
Active Control
Group I: microfracture surgery onlyActive Control1 Intervention
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 microfracture surgery (standard of care).
Group II: microfracture surgery + HST003Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

HistogenLead Sponsor
5 Previous Clinical Trials
395 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,193 Total Patients Enrolled
Mark A HubkaStudy DirectorHistogen

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the extent of participant involvement in this experiment?

"This experiment requires 20 eligible patients to register before it can begin. Possible locations for enrollment include Site 003 in San Diego, California and Site 001 in Bethesda, Maryland."

Answered by AI

Has the combination of microfracture surgery and HST003 been granted regulatory clearance by the FDA?

"Our Power team gauged the security of microfracture surgery + HST003 as a 1 since it is in Phase 1, meaning there are only limited results indicating its safety and efficacy."

Answered by AI

Are there any criteria I must meet to participate in the clinical trial?

"This research is looking for 20 individuals who have experienced microfractures and are between 18-50 years of age. To qualify, participants must be diagnosed with a symptomatic (knee pain, effusion, and limited physical activity) cartilage lesion in the femoral condyle that has not responded to other treatments. Isolated acute traumatic defects can also meet these selection criteria."

Answered by AI

What locations are offering access to this clinical experimentation?

"Currently, this medical trial is running at six locations - Site 003 in San Diego, Site 001 in Bethesda and Site 002 in Vail amongst other sites."

Answered by AI

Are there any current opportunities to take part in this scientific study?

"Affirmative. Data hosted on clinicaltrials.gov shows that this research trial, which was initially published on November 15th 2021, is presently recruiting participants. This study requires the enrolment of 20 patients at 6 distinct medical centres."

Answered by AI

What goals is the research team hoping to accomplish with this experiment?

"This 24-week trial will assess joint pain relative to microfracture treatment, as well as range of motion (ROM) and overall knee strength via Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) questionnaire measurements. Pain-free ROM beyond baseline will also be measured in comparison to the uninjured/untreated knee. Additionally, Minimum Joint Space Width (mJSW) is assessed by an experienced radiologist using Dynamika's computer aided functionality, while cartilage quality within repaired defects is determined through dGEMRIC imaging. The data collected from both processes are used to evaluate efficacy over a Day 168"

Answered by AI

Does this experiment include seniors in its participant pool?

"This clinical trial is open to patients aged between 18 and 50, in alignment with the set inclusion criteria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage
2021. "Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05082831.
~0 spots leftby Apr 2025
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