Intra-articular Injection of Axolotl Ambient for Osteoarthritis
(Phoenix Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a special fluid called Axolotl Ambient, which is injected directly into the ankle joint. It aims to help people with ankle osteoarthritis by reducing pain and improving movement. The study will evaluate if this treatment really works and is safe.
Will I have to stop taking my current medications?
Participants must stop taking all prescription and over-the-counter pain medications for ankle osteoarthritis during the study, except for acetaminophen, which cannot be used for 3 days before and on the day of each follow-up visit.
Is the intra-articular injection of Axolotl Ambient safe for humans?
How is the treatment Axolotl Ambient different from other osteoarthritis treatments?
Axolotl Ambient is unique because it is administered directly into the joint (intra-articular injection), which can increase the amount of the treatment available at the site of arthritis and reduce side effects compared to treatments taken by mouth. This method is different from traditional oral medications and may offer benefits like fewer side effects and potentially lower costs.16789
What data supports the effectiveness of the treatment Axolotl Ambient for osteoarthritis?
Intra-articular injections, like those used in the Axolotl Ambient treatment, can be effective for osteoarthritis because they deliver medication directly to the affected joint, potentially increasing effectiveness and reducing side effects. Similar treatments, such as injections of autologous conditioned serum, have shown considerable symptom relief in clinical trials.1291011
Who Is on the Research Team?
Robert S. Kellar, PhD
Principal Investigator
Chief Science Officer (CSO)
Aaron J. Tabor, PhD, CTBS
Principal Investigator
V.P. of Clinical Operations
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intra-articular injection of either Axolotl Ambient or saline
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 0.9% Normal Saline
- Axolotl Ambient
Find a Clinic Near You
Who Is Running the Clinical Trial?
Axolotl Biologix
Lead Sponsor