Degenerative SpondylolisthesisPhase 1/2NCT04378543
Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion
A Phase 1/2 study testing ART352-L in people with Degenerative Spondylolisthesis, run by Ankasa Regenerative Therapeutics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degenerative Spondylolisthesis
- What is being tested?
- ART352-L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2020to Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Sanford Madigan, PhD contact
United States3 sites, 3 recruiting
- Recruiting
Wexner Medical Center, The Ohio State University
Columbus, Ohio, 43210
Safdar Khan, MD
- Recruiting
Keck School of Medicine, University of Southern California
Los Angeles, California, 90033
Jeffrey Wang, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Brett Freedman, MD
About this study
Official title: A Phase 1b/2a Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion
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
- Being tested
- ART352-L
- Keywords
- spine, spondylolisthesis, degenerative disc disease, back pain
- Medical subject headings
- Spondylolisthesis, Intervertebral Disc Degeneration, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART352-LBiological
recombinant human Wnt3a protein delivered on liposomes to local autologous bone graft during posterolateral fusion procedures
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: ART352-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence of adverse events and adverse events of special interest
Measured: 2 weeks
Safety and Tolerability
Incidence of adverse events and adverse events of special interest
Measured: 8 weeks
Safety and Tolerability
Incidence of adverse events and adverse events of special interest
Measured: 26 weeks
Safety and Tolerability
Incidence of adverse events and adverse events of special interest
Measured: 52 weeks
Safety and Tolerability
Incidence of adverse events and adverse events of special interest
Measured: 104 weeks
Secondary outcomes (19)
Rate of early fusion
Rate of early fusion using Lenke scoring of computed tomography (CT) scans
Measured: 26 weeks
Rate of fusion
Rate of fusion using Lenke scoring of CT scans
Measured: 52 weeks
Rate of fusion
Rate of fusion using Lenke scoring of CT scans
Measured: 104 weeks
Oswestry Disability Index
Change from baseline in Oswestry Disability Index
Measured: 8 weeks
Oswestry Disability Index
Change from baseline in Oswestry Disability Index
Measured: 26 weeks
Oswestry Disability Index
Change from baseline in Oswestry Disability Index
Measured: 52 weeks
Oswestry Disability Index
Change from baseline in Oswestry Disability Index
Measured: 104 weeks
Short Form-36 (SF-36)
Change from baseline in Short Form-36 (SF-36) score
Measured: 8 weeks
Short Form-36 (SF-36)
Change from baseline in Short Form-36 (SF-36) score
Measured: 26 weeks
Short Form-36 (SF-36)
Change from baseline in Short Form-36 (SF-36) score
Measured: 52 weeks
Short Form-36 (SF-36)
Change from baseline in Short Form-36 (SF-36) score
Measured: 104 weeks
Visual Analog Scale (VAS) Pain
Change from baseline in Visual Analog Scale (VAS) Pain assessment
Measured: 8 weeks
Visual Analog Scale (VAS) Pain
Change from baseline in Visual Analog Scale (VAS) Pain assessment
Measured: 26 weeks
Visual Analog Scale (VAS) Pain
Change from baseline in Visual Analog Scale (VAS) Pain assessment
Measured: 52 weeks
Visual Analog Scale (VAS) Pain
Change from baseline in Visual Analog Scale (VAS) Pain assessment
Measured: 104 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score
Measured: 8 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score
Measured: 26 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score
Measured: 52 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start30 Sep 2020
- Primary completionApr 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative SpondylolisthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankasa Regenerative Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378543
- Sponsor's protocol ID
- ART-SPF-ART352L-001
- Status last verified
- Oct 2020
- First submitted
- 30 Apr 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion
- ClinicalTrials.gov ID
- NCT04378543
- Acronym / sponsor ID
- ART-SPF-ART352L-001
- Conditions
- Degenerative Spondylolisthesis
- Keywords
- spine, spondylolisthesis, degenerative disc disease, back pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ankasa Regenerative Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ART252-L | Experimental | Biological: ART352-Llocal autologous bone graft will be treated ex vivo once with ART352-L prior to re-implantation into the site of spinal fusion |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ART352-Lrecombinant human Wnt3a protein delivered on liposomes to local autologous bone graft during posterolateral fusion procedures | Biological | ART252-L |
Primary outcome
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
19 secondary outcomes
Rate of early fusion
Time frame: 26 weeks
Rate of fusion
Time frame: 52 weeks
Rate of fusion
Time frame: 104 weeks
Oswestry Disability Index
Time frame: 8 weeks
Oswestry Disability Index
Time frame: 26 weeks
Oswestry Disability Index
Time frame: 52 weeks
Oswestry Disability Index
Time frame: 104 weeks
Short Form-36 (SF-36)
Time frame: 8 weeks
Short Form-36 (SF-36)
Time frame: 26 weeks
Short Form-36 (SF-36)
Time frame: 52 weeks
Short Form-36 (SF-36)
Time frame: 104 weeks
Visual Analog Scale (VAS) Pain
Time frame: 8 weeks
Visual Analog Scale (VAS) Pain
Time frame: 26 weeks
Visual Analog Scale (VAS) Pain
Time frame: 52 weeks
Visual Analog Scale (VAS) Pain
Time frame: 104 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Time frame: 8 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Time frame: 26 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Time frame: 52 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Time frame: 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanford Madigan, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ART352-L in people with Degenerative Spondylolisthesis, run by Ankasa Regenerative Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gloria Matthews, DVM, PhD (404-947-6472, gmatthews@wnt3.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.