Intra-articular Injection of Axolotl Ambient for Osteoarthritis

(Phoenix Trial)

Recruiting at 3 trial locations

Overseen By Jennifer Jennings

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Axolotl Biologix

Must not be taking: Anticoagulants, Systemic steroids, Methotrexate, others

Disqualifiers: Systemic inflammatory condition, Bone disease, Autoimmune disease, others

Compensation: Varies

Number of Visits: 5

Duration: 1 day

12 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

Is the intra-articular injection of Axolotl Ambient safe for humans?

The research on intra-articular therapies, including gene therapies and other novel treatments, generally shows a favorable safety profile with minimal adverse effects in animal models. However, specific safety data for Axolotl Ambient in humans is not provided in the available research. ^{1 4 6 7 8}

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. ^{1 2 9 10 11}

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.

Research Team

Robert S. Kellar, PhD

Principal Investigator

Chief Science Officer (CSO)

Aaron J. Tabor, PhD, CTBS

Principal Investigator

V.P. of Clinical Operations

Eligibility Criteria

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

Signed written informed consent

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.

Exclusion Criteria

Pregnancy, breastfeeding, or woman of child-bearing potential not using adequate contraception

I have a bone deficit.

I am on prescription pain medication for a condition other than ankle osteoarthritis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular injection of either Axolotl Ambient or saline

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up at 4 weeks, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• 0.9% Normal Saline
• Axolotl Ambient

Trial Overview 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.

Participant Groups

Group I: Investigational Group Experimental Treatment 1 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 Group Placebo Group 1 Intervention

Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.

Who Is Running the Clinical Trial?

Axolotl Biologix

Lead Sponsor

Trials

2

Recruited

110+

References

1. United States pubmed.ncbi.nlm.nih.gov

Progress in intra-articular therapy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Single Intra-Articular Injection of Autologous Protein Solution for Treatment of Osteoarthritis in a Canine Population. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Novel biological approaches to the intra-articular treatment of osteoarthritis. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Gene Therapy for Osteoarthritis: Pharmacokinetics of Intra-Articular Self-Complementary Adeno-Associated Virus Interleukin-1 Receptor Antagonist Delivery in an Equine Model. [2019]

5. England pubmed.ncbi.nlm.nih.gov

scAAVIL-1ra dosing trial in a large animal model and validation of long-term expression with repeat administration for osteoarthritis therapy. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of FX201, a Novel Intra-Articular IL-1Ra Gene Therapy for Osteoarthritis Treatment, in a Rat Model. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of intra-articular therapies in osteoarthritis: a literature review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The TAT Protein Transduction Domain as an Intra-Articular Drug Delivery Technology. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Intra-articular Injectates: What to Use and Why. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Perceived efficacy and risks of infection following intra-articular injections: a survey of orthopaedic surgeons. [2019]

11. England pubmed.ncbi.nlm.nih.gov

State of art in intra-articular hip injections of different medications for osteoarthritis: a systematic review. [2023]