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Protein Therapy
ART352-L for Degenerative Spondylolisthesis
Phase 1 & 2
Waitlist Available
Research Sponsored by Ankasa Regenerative Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 104 weeks
Awards & highlights
Study Summary
This trial is testing a new way to treat degenerative spondylolisthesis by using a liposomal formulation of recombinant human Wnt3A protein applied ex vivo to harvested autologous bone grafts. The goal is to improve the safety and tolerability of this treatment and to evaluate the rates of early and overall spinal fusion.
Eligible Conditions
- Degenerative Spondylolisthesis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 104 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~104 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability
Secondary outcome measures
Oswestry Disability Index
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Rate of early fusion
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ART252-LExperimental Treatment1 Intervention
local autologous bone graft will be treated ex vivo once with ART352-L prior to re-implantation into the site of spinal fusion
Find a Location
Who is running the clinical trial?
Ankasa Regenerative Therapeutics, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking medications that can affect the health of your bones, like bisphosphonates.You have been using opioid medication for a long time.You do not have any problems with your movement or strength.You are allergic to recombinant Wnt proteins.You have a history of blood clots in your veins or problems with blood clotting.You have very weak bones that are at a high risk of breaking, and you are currently receiving treatment for it.You have had a previous surgery to fuse your lower back bones together.You have severe slipping of multiple spinal bones or your low back pain is caused by something other than a specific type of spine condition called degenerative spondylolisthesis.You have a mild or lower degree of spinal misalignment.You have a serious autoimmune disorder or a disease that causes inflammation throughout your body at the same time as the clinical trial.You have been in pain for at least 6 months despite trying different treatments like medication, physical therapy, and chiropractic care.Your ODI score, which measures how much your back pain affects your daily activities, is 30 or higher before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: ART252-L
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Degenerative Spondylolisthesis Patient Testimony for trial: Trial Name: NCT04378543 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers currently being admitted to this research initiative?
"Confirmed, this clinical trial is actively enrolling patients. It was first listed on September 30th 2020 and had its last update just ten days later."
Answered by AI
What is the scale of this medical study's participant pool?
"Affirmative. Clinicaltrials.gov shows that this research project, first presented on September 30th 2020, is actively seeking participants. 12 volunteers must be recruited from 3 different medical sites."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
California
Ohio
How old are they?
65+
What site did they apply to?
Keck School of Medicine, University of Southern California
Wexner Medical Center, The Ohio State University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have been in moderate to severe pain for a year and a half due to my spondilolisthesis and have tried physical therapy and chiropractic care and have not achieved satisfactory results. I am hoping for a solution other than fusion surgery.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long do screening visits take?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Wexner Medical Center, The Ohio State University: < 24 hours
Average response time
- < 1 Day
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