Status:
UNKNOWN
Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion
Lead Sponsor:
Ankasa Regenerative Therapeutics, Inc.
Conditions:
Degenerative Spondylolisthesis
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
Ankasa Regenerative Therapeutics, Inc. (Ankasa) is developing ART352-L, a liposomal formulation of recombinant human Wnt3A protein, that is applied ex vivo, to harvested autologous bone grafts (autogr...
Eligibility Criteria
Inclusion
- 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 Disability 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 90 days after administration of Investigational Product (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
- Multiple level spondylolistheses or a primary diagnosis of low back pain syndrome secondary to diseases other than degenerative spondylolisthesis
- Concurrent medications that affect bone homeostasis including, but not limited to, bisphosphonates
- 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
- 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 90 days 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
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04378543
Start Date
September 30 2020
End Date
October 1 2023
Last Update
October 12 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Keck School of Medicine, University of Southern California
Los Angeles, California, United States, 90033
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Wexner Medical Center, The Ohio State University
Columbus, Ohio, United States, 43210