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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.

Tracking Information
First Submitted Date  ICMJE April 30, 2020
First Posted Date  ICMJE May 7, 2020
Last Update Posted Date October 12, 2020
Actual Study Start Date  ICMJE September 30, 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Safety and Tolerability [ Time Frame: 2 weeks ]
    Incidence of adverse events and adverse events of special interest
  • Safety and Tolerability [ Time Frame: 8 weeks ]
    Incidence of adverse events and adverse events of special interest
  • Safety and Tolerability [ Time Frame: 26 weeks ]
    Incidence of adverse events and adverse events of special interest
  • Safety and Tolerability [ Time Frame: 52 weeks ]
    Incidence of adverse events and adverse events of special interest
  • Safety and Tolerability [ Time Frame: 104 weeks ]
    Incidence of adverse events and adverse events of special interest
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Rate of early fusion [ Time Frame: 26 weeks ]
    Rate of early fusion using Lenke scoring of computed tomography (CT) scans
  • Rate of fusion [ Time Frame: 52 weeks ]
    Rate of fusion using Lenke scoring of CT scans
  • Rate of fusion [ Time Frame: 104 weeks ]
    Rate of fusion using Lenke scoring of CT scans
  • Oswestry Disability Index [ Time Frame: 8 weeks ]
    Change from baseline in Oswestry Disability Index
  • Oswestry Disability Index [ Time Frame: 26 weeks ]
    Change from baseline in Oswestry Disability Index
  • Oswestry Disability Index [ Time Frame: 52 weeks ]
    Change from baseline in Oswestry Disability Index
  • Oswestry Disability Index [ Time Frame: 104 weeks ]
    Change from baseline in Oswestry Disability Index
  • Short Form-36 (SF-36) [ Time Frame: 8 weeks ]
    Change from baseline in Short Form-36 (SF-36) score
  • Short Form-36 (SF-36) [ Time Frame: 26 weeks ]
    Change from baseline in Short Form-36 (SF-36) score
  • Short Form-36 (SF-36) [ Time Frame: 52 weeks ]
    Change from baseline in Short Form-36 (SF-36) score
  • Short Form-36 (SF-36) [ Time Frame: 104 weeks ]
    Change from baseline in Short Form-36 (SF-36) score
  • Visual Analog Scale (VAS) Pain [ Time Frame: 8 weeks ]
    Change from baseline in Visual Analog Scale (VAS) Pain assessment
  • Visual Analog Scale (VAS) Pain [ Time Frame: 26 weeks ]
    Change from baseline in Visual Analog Scale (VAS) Pain assessment
  • Visual Analog Scale (VAS) Pain [ Time Frame: 52 weeks ]
    Change from baseline in Visual Analog Scale (VAS) Pain assessment
  • Visual Analog Scale (VAS) Pain [ Time Frame: 104 weeks ]
    Change from baseline in Visual Analog Scale (VAS) Pain assessment
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion
Official Title  ICMJE A Phase 1b/2a Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Degenerative Spondylolisthesis
Intervention  ICMJE Biological: ART352-L
recombinant human Wnt3a protein delivered on liposomes to local autologous bone graft during posterolateral fusion procedures
Study Arms  ICMJE 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
Intervention: Biological: ART352-L
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gloria Matthews, DVM, PhD 404-947-6472 gmatthews@wnt3.com
Contact: Sanford Madigan, PhD smadigan@wnt3.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04378543
Other Study ID Numbers  ICMJE ART-SPF-ART352L-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ankasa Regenerative Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ankasa Regenerative Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ankasa Regenerative Therapeutics, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP