What side effects are associated with this type of intervention?

Common treatments for osteoarthritis with anti-inflammatory and regenerative properties include NSAIDs, intra-articular glucocorticoids, and platelet-rich plasma (PRP) injections. NSAIDs can cause gastrointestinal issues, cardiovascular risks, and renal problems. Intra-articular glucocorticoid injections may lead to joint infection, increased pain, and potential cartilage damage with repeated use. PRP injections generally have minor side effects like pain, swelling, and bruising at the injection site, but their long-term efficacy and safety are still under investigation.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, primarily focusing on pain relief and inflammation reduction. Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, and diclofenac are commonly used for their efficacy in reducing pain and inflammation. Additionally, anti-NGF agents like tanezumab and fasinumab have shown promise in clinical trials for pain reduction, although tanezumab's development was halted due to safety concerns. Regenerative treatments like platelet-rich plasma (PRP) are still under investigation, with mixed results and no definitive FDA approval for osteoarthritis management.

What other types of research exist?

Promising alternatives to Axolotl Ambient for osteoarthritis treatment include: 1) Mesenchymal stem cell (MSC) injections, which contain anti-inflammatory molecules and may attenuate joint destruction or remodel the joint. 2) Navitoclax (ABT263), a senolytic drug that reduces inflammation and promotes cartilage regeneration by clearing senescent osteoarthritic chondrocytes. 3) TRB-N0224, a chemically modified curcumin with zinc binding properties, which has shown to reduce inflammatory cytokines and cartilage erosion in preclinical models. 4) Autologous protein solutions and conditioned serum, which have anti-inflammatory properties and potential regenerative effects.

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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

Must not have

Modified K-L Grade 3b or 4 osteoarthritis of the index joint

Received intra-articular steroid injection in the index joint within the last 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My joint condition is severe or very severe according to a specific grading.

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I've had a steroid injection in my joint within the last 3 months.

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I have not had surgery on my ankle in the last year.

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I am scheduled for an ankle procedure during the study.

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I need treatment for arthritis in both of my ankles.

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I have a bone deficit.

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I have Charcot foot disease.

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I have a condition that causes body-wide inflammation.

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I have poor blood flow in my vessels.

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I am currently taking blood thinners.

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My spine is curved more than 30 degrees.

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I weigh less than 47 kg.

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I have a severe bone condition, like osteoporosis or avascular necrosis.

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I do not have an infection at the site of injection.

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I am not on medications that affect bone or cartilage, except for topical steroids.

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I need treatment like radiation, chemotherapy, or drugs that affect my immune system.

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I have a history of cancer, other than skin cancer.

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I have an autoimmune disease that affects my bones or joints.

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I cannot walk 50 meters without help from a device.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients achieving Composite Clinical Success

Secondary study objectives

Current Working Status

EuroQOL-5 dimension-5 level quality of life scale

Incidence of Adverse Events

+4 more

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.

0 / 26Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Osteoarthritis (OA) primarily target inflammation and pain relief. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen reduce inflammation by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the production of inflammatory prostaglandins. Glucocorticoids, such as prednisone, provide potent anti-inflammatory effects by suppressing multiple inflammatory pathways. Investigational treatments like Platelet-Rich Plasma (PRP) aim to harness the body's healing mechanisms by delivering high concentrations of growth factors to the affected joint, potentially promoting tissue regeneration. Gene therapies, such as those involving TGF-beta, focus on enhancing cartilage repair and reducing joint degradation. These treatments are crucial for OA patients as they not only alleviate pain and improve function but also hold the potential to modify disease progression and promote joint health.

New Trends in Pharmacological Treatments for Osteoarthritis.