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Intra-articular Injection of Axolotl Ambient for Osteoarthritis (Phoenix Trial)
Phase 1 & 2
Waitlist Available
Led By Robert S. Kellar, PhD
Research Sponsored by Axolotl Biologix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female trial participants must commit to adequate birth control (e.g., surgically sterilized, oral contraceptive, two methods of barrier birth control, or abstinence) through the final follow-up visit
Male or female at least 18 years of age and less than 80
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Phoenix Trial Summary
This trial will compare the safety and effectiveness of a new potential treatment for ankle osteoarthritis (Axolotl Ambient) to a placebo.
Who is the study for?
Adults aged 18-79 with ankle osteoarthritis, experiencing chronic pain for at least 6 months and willing to stop most pain medications can join. Women must not be pregnant and use birth control. Exclusions include major prior ankle surgery, certain medical conditions like severe bone diseases or systemic inflammatory conditions, recent treatments with similar injections or steroids in the affected joint.Check my eligibility
What is being tested?
The study tests Axolotl Ambient, an intra-articular injection for ankle osteoarthritis pain relief against a saline placebo. Participants are randomly assigned to either the treatment or placebo group without knowing which one they receive (double-blind). The trial aims to assess safety and effectiveness of the drug.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from injections may include temporary pain at the injection site, swelling, stiffness, and possible allergic reactions. Uncommon risks might involve infection or damage to nearby structures.
Phoenix Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using or willing to use effective birth control methods until the final follow-up.
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I am between 18 and 79 years old.
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I have been diagnosed with mild to moderate ankle arthritis.
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My most affected joint is one ankle, and it's the only one I plan to treat.
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I am using or willing to use effective birth control methods until the final follow-up.
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I have had ankle pain for 6 months or more.
Phoenix Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients achieving Composite Clinical Success
Secondary outcome measures
Current Working Status
EuroQOL-5 dimension-5 level quality of life scale
Incidence of Adverse Events
+4 morePhoenix Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigational GroupExperimental Treatment1 Intervention
Biological/Vaccine: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intraarticular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Names:
• CA20
Group II: Control GroupPlacebo Group1 Intervention
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Axolotl BiologixLead Sponsor
Aaron J. Tabor, PhDStudy DirectorV.P. of Clinical Operations
Robert S. Kellar, PhDPrincipal InvestigatorChief Science Officer (CSO) Contact: rskellar@axobio.com Phone: 928-600-6608
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bone deficit.I am on prescription pain medication for a condition other than ankle osteoarthritis.I have had a hyaluronic acid injection in my joint within the last 6 months.I have had ankle pain for 6 months or more.I am using or willing to use effective birth control methods until the final follow-up.I have a history of cancer, other than skin cancer.I have an autoimmune disease that affects my bones or joints.I cannot walk 50 meters without help from a device.I have had major ankle surgery that could affect study results.I weigh less than 47 kg.I have a severe bone condition, like osteoporosis or avascular necrosis.I am not on medications that affect bone or cartilage, except for topical steroids.I need treatment like radiation, chemotherapy, or drugs that affect my immune system.I am willing to be assigned to any treatment group in the study.I am between 18 and 79 years old.I have been diagnosed with mild to moderate ankle arthritis.My most affected joint is one ankle, and it's the only one I plan to treat.I am willing and able to follow all study requirements.I am using or willing to use effective birth control methods until the final follow-up.I have had injections like PRP in my joint within the last year.My joint condition is severe or very severe according to a specific grading.I have arthritis near the same side of my joint problem that might affect the study.I agree to stop taking all pain meds for my ankle OA, except acetaminophen, which I won't take for 3 days before each visit.I've had a steroid injection in my joint within the last 3 months.I have not had surgery on my ankle in the last year.I am scheduled for an ankle procedure during the study.I need treatment for arthritis in both of my ankles.I have Charcot foot disease.I have a condition that causes body-wide inflammation.I have poor blood flow in my vessels.I am currently taking blood thinners.My spine is curved more than 30 degrees.I do not have an infection at the site of injection.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Investigational Group
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are receiving therapy in this research project?
"That is correct. The online clinicaltrials.gov registry currently has this trial listed as open and recruiting. This particular study was posted on December 1st, 2021 and was updated on October 27th, 2022. There are 4 sites enrolling a total of 48 patients."
Answered by AI
If a patient is not yet 45 years old, are they still eligible for this clinical trial?
"By meeting the age requirements of 18 years or older, and 80 years or younger, potential patients can adhere to the age bracket set by the inclusion criteria."
Answered by AI
If I am eligible, can I sign up for this research opportunity?
"Those afflicted with arthrosis and aged between 18 and 80 may be eligible for this clinical trial, of which the researchers are looking for a total of 48 individuals."
Answered by AI
Can people with the relevant medical condition still enroll in this trial?
"Yes. The trial, which was posted on December first 2021 and updated on October 27th 2022, is currently looking for 48 patients from 4 different medical centres."
Answered by AI
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