Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regene… (NCT05082831) | Clinical Trial Compass
TerminatedPhase 1
Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage
Stopped: Difficulty in enrollment
United States1 participantsStarted 2021-11-15
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participant must be ≥ 18 years and ≤ to 50 years of age (18-50), at the time of signing the informed consent.
✓. Patients who are "healthy" as determined by medical evaluation including medical history, physical exam, laboratory tests, no thyroid conditions, and no history of cancer, etc.
✓. Patients with controlled hypertension defined as systolic blood pressure less than 140mmHg and diastolic blood pressure less than 90mmHg.
✓. Patients with well controlled diabetes mellitus type 2 defined as an HbA1C of less than 6.5%.
✓. Patients that have hematological parameters as follows: hematocrit ≥ 28.0%, white blood cell count ≤ 14,000/mm3, platelet count ≥ 50,000/mm3, creatinine
✓. Patients that have been diagnosed with a symptomatic (knee pain, effusion, and limitation of activity due to the lesion) cartilage lesion of the medial or lateral femoral condyle and have failed to respond to more conservative pharmacologic or non-pharmacologic treatments. Acute, isolated, traumatic defects are permitted in the study.
✓. A cartilage lesion on the medial or lateral femoral condyle that is Grade III or IV on the Outerbridge scale, and having size of 2 cm2 - 4 cm2 as detected by MRI or recent arthroscopy if conducted in connection with this acute knee injury.
What they're measuring
1
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
Timeframe: Day 168 (week 24, Visit 8)
2
Assessment of joint pain equal to or lesser than microfracture alone, and equal or greater function, as measured using the validated IKDC (International Knee Documentation Committee) questionnaire
Timeframe: Day 168 (week 24, Visit 8)
3
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
Timeframe: Day 168 (week 24, Visit 8)
4
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
. Intact ligaments - including intact (i) anterior cruciate ligament (ACL), (ii) lateral collateral ligament (LCL), (iii) posterior cruciate ligament (PCL), and (iv) medial collateral ligament (MCL). No concurrent ligament surgery is permitted.
Exclusion criteria
✕. History of substantial (greater than or equal to 50%) meniscal repair or a meniscectomy.
✕. Body Mass Index (BMI) of ≥ 35 kg/m2 and \< 18 kg/m2, at the time of screening (see inclusion criteria 17 above).
✕. Known, recent (within one month of screening) history of bacterial infection regardless of body location.
✕. Prior surgical repair of the site (femoral condyle) intended to undergo microfracture surgery. No prior microfracture of the index knee is permitted.
✕. Single Assessment Numeric Evaluation (SANE) of greater than 80.
✕. Prior surgery of the contralateral knee within the last 3 months (since opposite knee needs to be intact for the non-weightbearing period post-op).
✕. Known kidney impairment, for which contrast agents for MRI could add to risks (see inclusion 16 and exclusion 13).
✕. Has vascular disorders such as varicose veins or peripheral arterial disease or neurological disorders (e.g., neuropathy affecting the index lower limb).