A Study to Evaluate the Safety of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion

Overview

About this study

The primary purpose of this study is to evaluate the safety and tolerability of ART352-L treated local bone autograft in subjects undergoing a spinal fusion procedure to treat lumbar degenerative spondylolisthesis.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Brett Freedman, M.D.

Open for enrollment

Contact information:

Kelsey Klapperick

(507) 293-7392

Klapperick.Kelsey@mayo.edu

More information

Publications

Publications are currently not available