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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378543
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Ankasa Regenerative Therapeutics, Inc.

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.


Condition or disease Intervention/treatment Phase
Degenerative Spondylolisthesis Biological: ART352-L Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : October 2023

Arm Intervention/treatment
Experimental: ART252-L
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
recombinant human Wnt3a protein delivered on liposomes to local autologous bone graft during posterolateral fusion procedures




Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 2 weeks ]
    Incidence of adverse events and adverse events of special interest

  2. Safety and Tolerability [ Time Frame: 8 weeks ]
    Incidence of adverse events and adverse events of special interest

  3. Safety and Tolerability [ Time Frame: 26 weeks ]
    Incidence of adverse events and adverse events of special interest

  4. Safety and Tolerability [ Time Frame: 52 weeks ]
    Incidence of adverse events and adverse events of special interest

  5. Safety and Tolerability [ Time Frame: 104 weeks ]
    Incidence of adverse events and adverse events of special interest


Secondary Outcome Measures :
  1. Rate of early fusion [ Time Frame: 26 weeks ]
    Rate of early fusion using Lenke scoring of computed tomography (CT) scans

  2. Rate of fusion [ Time Frame: 52 weeks ]
    Rate of fusion using Lenke scoring of CT scans

  3. Rate of fusion [ Time Frame: 104 weeks ]
    Rate of fusion using Lenke scoring of CT scans

  4. Oswestry Disability Index [ Time Frame: 8 weeks ]
    Change from baseline in Oswestry Disability Index

  5. Oswestry Disability Index [ Time Frame: 26 weeks ]
    Change from baseline in Oswestry Disability Index

  6. Oswestry Disability Index [ Time Frame: 52 weeks ]
    Change from baseline in Oswestry Disability Index

  7. Oswestry Disability Index [ Time Frame: 104 weeks ]
    Change from baseline in Oswestry Disability Index

  8. Short Form-36 (SF-36) [ Time Frame: 8 weeks ]
    Change from baseline in Short Form-36 (SF-36) score

  9. Short Form-36 (SF-36) [ Time Frame: 26 weeks ]
    Change from baseline in Short Form-36 (SF-36) score

  10. Short Form-36 (SF-36) [ Time Frame: 52 weeks ]
    Change from baseline in Short Form-36 (SF-36) score

  11. Short Form-36 (SF-36) [ Time Frame: 104 weeks ]
    Change from baseline in Short Form-36 (SF-36) score

  12. Visual Analog Scale (VAS) Pain [ Time Frame: 8 weeks ]
    Change from baseline in Visual Analog Scale (VAS) Pain assessment

  13. Visual Analog Scale (VAS) Pain [ Time Frame: 26 weeks ]
    Change from baseline in Visual Analog Scale (VAS) Pain assessment

  14. Visual Analog Scale (VAS) Pain [ Time Frame: 52 weeks ]
    Change from baseline in Visual Analog Scale (VAS) Pain assessment

  15. Visual Analog Scale (VAS) Pain [ Time Frame: 104 weeks ]
    Change from baseline in Visual Analog Scale (VAS) Pain assessment

  16. Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10 [ Time Frame: 8 weeks ]
    Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score

  17. Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10 [ Time Frame: 26 weeks ]
    Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score

  18. Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10 [ Time Frame: 52 weeks ]
    Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score

  19. Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10 [ Time Frame: 104 weeks ]
    Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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
  3. Willing and able to undergo diagnostic imaging, inclusive of X-rays and CT scans with contrast
  4. 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
  5. Pre-operative Oswestry Disability Index (ODI) Score ≥30
  6. Grade 1 or less spondylolisthesis or retrolisthesis
  7. Absence of neurological motor deficit
  8. 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.
  9. Agree to remain nicotine-free for the duration of their participation in the study

Exclusion Criteria:

  1. Multiple level spondylolistheses or a primary diagnosis of low back pain syndrome secondary to diseases other than degenerative spondylolisthesis
  2. Concurrent medications that affect bone homeostasis including, but not limited to, bisphosphonates
  3. Ongoing / existing infections in or around the surgical site or spine
  4. Prior lumbar spine arthrodesis
  5. Concurrent clinically significant autoimmune disorder or systemic inflammatory disease
  6. Known hypersensitivity to recombinant Wnt proteins
  7. Use of tobacco; subjects must be nicotine-free at screening and agree to remain nicotine free for the duration of the study
  8. 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
  9. 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
  10. A Body Mass index (BMI) ≥ 40 unless documentation clearly demonstrates why BMI is not a primary factor in the subject's decreased mobility
  11. Chronic opioid use
  12. History of deep vein thrombosis (DVT) or blood clotting abnormalities
  13. Uncontrolled diabetes mellitus
  14. Pre-operative/anesthesia evaluations deeming the subject ineligible for surgery
  15. Female subjects who are pregnant or intend to become pregnant during the course of the study
  16. 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
  17. 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.
  18. Concurrent participation in another investigational drug, biologic or device study that could confound study data
  19. Involvement in or plans to engage in litigation or receiving Worker's Compensation related to neck, back, or leg pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378543


Contacts
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Contact: Gloria Matthews, DVM, PhD 404-947-6472 gmatthews@wnt3.com
Contact: Sanford Madigan, PhD smadigan@wnt3.com

Locations
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United States, California
Keck School of Medicine, University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Jeffrey Wang, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Brett Freedman, MD         
United States, Ohio
Wexner Medical Center, The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Safdar Khan, MD         
Sponsors and Collaborators
Ankasa Regenerative Therapeutics, Inc.
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Responsible Party: Ankasa Regenerative Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04378543    
Other Study ID Numbers: ART-SPF-ART352L-001
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ankasa Regenerative Therapeutics, Inc.:
spine
spondylolisthesis
degenerative disc disease
back pain
Additional relevant MeSH terms:
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Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases