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

NCT04378543 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: ART-SPF-ART352L-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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 (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.

Conditions

Degenerative Spondylolisthesis

Keywords

spine; spondylolisthesis; degenerative disc disease; back pain

Outcome Measures

Primary Outcomes (5)

• Safety and Tolerability

  Incidence of adverse events and adverse events of special interest

  2 weeks

• Safety and Tolerability

  Incidence of adverse events and adverse events of special interest

  8 weeks

• Safety and Tolerability

  Incidence of adverse events and adverse events of special interest

  26 weeks

• Safety and Tolerability

  Incidence of adverse events and adverse events of special interest

  52 weeks

• Safety and Tolerability

  Incidence of adverse events and adverse events of special interest

  104 weeks

Secondary Outcomes (19)

• Rate of early fusion

  26 weeks

• Rate of fusion

  52 weeks

• Rate of fusion

  104 weeks

• Oswestry Disability Index

  8 weeks

• Oswestry Disability Index

  26 weeks

Study Arms (1)

ART252-L

EXPERIMENTAL

local autologous bone graft will be treated ex vivo once with ART352-L prior to re-implantation into the site of spinal fusion

Biological: ART352-L

Interventions

ART352-L BIOLOGICAL

recombinant human Wnt3a protein delivered on liposomes to local autologous bone graft during posterolateral fusion procedures

ART252-L

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankasa Regenerative Therapeutics, Inc.: lead

Study Sites (3)

Keck School of Medicine, University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Wexner Medical Center, The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Spondylolisthesis; Intervertebral Disc Degeneration; Back Pain

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gloria Matthews, DVM, PhD

CONTACT

404-947-6472; gmatthews@wnt3.com

Sanford Madigan, PhD

CONTACT

smadigan@wnt3.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 7, 2020
• Study Start: September 30, 2020
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2023
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)