Ensayos clínicos

Inclusion Criteria:

• Male or female subjects ≥ 50 years of age scheduled to undergo single level posterolateral lumbar spinal fusion surgery in conjunction with local autograft bone for degenerative spondylolisthesis, spondylosis, and/or stenosis.
• Psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
• Willing and able to undergo diagnostic imaging, inclusive of X-rays and CT scans with contrast.
• Persistent, disabling pain after at least 6 months of non-surgical intervention (e.g., anti-inflammatory medication, physical therapy, chiropractic care) prior to providing informed consent.
• Pre-operative Oswestry Disabilty Index (ODI) Score ≥ 30.
• Grade 1 or less spondylolisthesis or retrolisthesis.
• Absence of neurological motor deficit.
• Agree to use a highly reliable method of birth control (male and female subjects) for at least 9 months after administration of IP.
• Women of childbearing potential must have a negative pregnancy test at screening and again ≤ 7 days prior to surgery. Perimenopausal women must be amenorrheic for at least 12 months prior to the time of providing informed consent to be considered of non-childbearing potential.
• Agree to remain nicotine-free for the duration of their participation in the study.

Exclusion Criteria:

• Multiple level spondylolistheses or a primary diagnosis of low back pain syndrome secondary to diseases other than degenerative spondylolisthesis
• Unwillingness or inability to abstain from medications that affect bone homeostasis including, but not limited to, bisphosphonates and other forms of bone anabolic medications (e.g., Forteo, Reclast, Fosamax, etc.).
• Unwillingness or inability to abstain from non-steroidal anti-inflammatory medications/arthritis medicines (such as Advil, Aleve, Ibuprofen, Motrin, Clinoril, Indocin, Daypro, Naprosyn, Celebrex, Vioxx, etc.) from 5 days before surgery until the end of the study.
• Ongoing / existing infections in or around the surgical site or spine
• Prior lumbar spine arthrodesis.
• Concurrent clinically significant autoimmune disorder or systemic inflammatory disease
• Known hypersensitivity to recombinant Wnt proteins.
• Use of tobacco; subjects must be nicotine-free at screening and agree to remain nicotine free for the duration of the study.
• Use of medications that may impair cell proliferation and bone healing including: chemotherapy, radiation, chronic steroids and immunosuppressive drugs.
  • NOTE: Medications that may impair cell proliferation are to be discussed with the protocol medical monitor prior to enrollment.
• Severe established osteoporosis requiring active treatment; e.g., with bone density more than 2.5 standard deviations below the young adult mean with one or more osteoporotic fractures.
• A Body Mass index (BMI) ≥ 40 unless documentation clearly demonstrates why BMI is not a primary factor in the subject’s decreased mobility.
• Chronic opioid use.
• History of deep vein thrombosis (DVT) or blood clotting abnormalities.
• Uncontrolled diabetes mellitus.
• Uncontrolled hypertension, defined as average systolic blood pressure ≥ 140 mm Hg or an average diastolic blood pressure ≥ 90 mmHg.
• Diagnosed renal and/or liver failure.
• History of systemic infection with HIV, Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).
• Chronic alcohol abuse, defined as consistent consumption of 8 drinks or more per week for women and 15 drinks or more per week for men.
• Poor nutritional status (e.g., malnourished, undernourished).
• Chronic Obstructive Pulmonary Disease with forced expiratory volume less than 80% of normal.
• Connective tissue disorders (e.g., Ehlers-Danlos Syndrome).
• Peripheral Vascular Disease.
• Pre-operative/anesthesia evaluations deeming the subject ineligible for surgery.
• Female subjects who are pregnant or intend to become pregnant during the course of the study.
• Male subjects, if not infertile or surgically sterilized, who will not agree to use highly-effective contraception or to not donate sperm from screening until at least 9 months  after receiving IP.
• Active malignancy ≤ 5 years prior to providing informed consent.
  • EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix.
  • NOTE: If there is a history of prior malignancy, the subject must not be receiving other specific treatment for their cancer.
• Concurrent participation in another investigational drug, biologic or device study that could confound study data.
• Involvement in or plans to engage in litigation or receiving Worker's Compensation related to neck, back, or leg pain.

Eligibility last updated 8/10/23. Questions regarding updates should be