Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion

  • STATUS
    Recruiting
  • End date
    Oct 26, 2023
  • participants needed
    12
  • sponsor
    Ankasa Regenerative Therapeutics, Inc.
Updated on 26 January 2021

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 (autograft) to enhance the osteogenic properties of the autograft prior to reimplantation in orthopedic surgeries.

This is a phase 1/2 open label safety evaluation of ART352-L treated autologous bone grafts in patients undergoing posterolateral lumbar spinal fusion to treat single level degenerative spondylolisthesis. The primary objective of the study is to evaluate the safety and tolerability of ART352-L treated local bone autografts in patients being treated for this condition, with the secondary objective to evaluate the rates of early and overall spinal fusion. Additionally, changes in patient mobility and quality of life measures from baseline following treatment with ART352-L will be evaluated.

Details
Condition Degenerative Spondylolisthesis
Treatment ART352-L
Clinical Study IdentifierNCT04378543
SponsorAnkasa Regenerative Therapeutics, Inc.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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 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 Criteria

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
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