Intra-articular Injection of Axolotl Ambient for Osteoarthritis

(Phoenix Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Axolotl Ambient for individuals with ankle osteoarthritis, a condition causing joint pain and stiffness. The study aims to determine if this treatment can reduce pain and improve joint function compared to a saltwater injection (placebo). It involves two groups: one receives the Axolotl Ambient injection, and the other receives a saline injection. Suitable candidates have experienced chronic ankle pain for at least six months and have not recently received certain types of joint injections. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Axolotl Ambient, an injection made from human amnion cells, is under study for its safety in treating ankle osteoarthritis. However, past studies have not yet provided specific information about its safety in humans.

Since this treatment is in the early stages of testing, researchers are closely monitoring its safety. Early trials primarily focus on assessing safety and tolerability. While it hasn't been proven completely safe yet, experts are observing it carefully.

For those considering joining the trial, the main goal is to ensure safety and understand any possible side effects. As more participants join, researchers will gather more information to confirm the safety of Axolotl Ambient for treating this condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritis?

Unlike the standard treatments for osteoarthritis, which often involve pain relief medications or physical therapy, Axolotl Ambient offers a novel approach by using an allogeneic amniotic fluid injection. This treatment is derived from human amnion cells and is rich in growth factors and cytokines, which are believed to promote joint healing and reduce inflammation. Researchers are excited because this could potentially provide not just symptom relief but also a regenerative effect on the affected joints, something current treatments don't offer. Additionally, the intra-articular injection directly targets the joint, providing a focused and potentially faster action compared to oral medications.

What evidence suggests that Axolotl Ambient might be an effective treatment for ankle osteoarthritis?

Research shows that Axolotl Ambient, an injection derived from a part of the placenta, might help treat osteoarthritis. In this trial, participants in the investigational group will receive Axolotl Ambient, which involves injecting a protein-rich fluid directly into the affected ankle joint to aid cell communication. Studies have shown that such injections can effectively deliver medicine to the joint, potentially reducing pain and improving joint function. Although specific results for Axolotl Ambient in treating ankle osteoarthritis are not yet available, similar treatments have successfully aided wound healing. These early findings suggest that Axolotl Ambient could reduce pain and improve joint function for individuals with ankle osteoarthritis. ^{1 2 3 6 7}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-2-osteoarthritis-10-2021-47ac5

Intra-articular Injection of 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05092646?tab=results

No Study Results Posted | NCT05092646 | Evaluating Intra ... A type of observational study that collects information about patients ... Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects ...

3. synapse.patsnap.com synapse.patsnap.com/organization/53f76887b71abb6a8ab7e4c5e7164f09

Axolotl Biologix, Inc. - Drug pipelines, Patents, Clinical trials ... Axolotl Ambient Compared to Saline in Subjects With Ankle Osteoarthritis. 100 Clinical Results associated with Axolotl Biologix, Inc. Login to view more data.

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05092646?keyword=%22Biologic%22

Evaluating Intra-articular Injection of Axolotl Ambient ... The primary outcomes will consist of patient reported outcomes of pain and functional assessment by the physician, specific to the foot and ankle. Subjects will ...

5. acquaintpublications.com acquaintpublications.com/article/amniotic_membrane_and_amnion_conditioned_media_promote_chronic_wound_healing_a_case_report

Amniotic Membrane and Amnion-Conditioned Media ... Regenerative therapies such as amniotic membrane and amnion cell-derived fluid, have been used to promote successful chronic wound healing and repair.

6. southcarolinablues.com southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/amniotic-membrane-and-amniotic-fluid-injections-for-non-ophthalmic-applications/

Amniotic Membrane and Amniotic Fluid Injections for Non- ... Outcomes included the Knee Injury and Osteoarthritis Outcome Score, International Knee Documentation Committee scale, and a numeric pain scale. Statistical ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05092646?cond=%22Osteoarthritis%22&intr=%22vaccines%22&viewType=Table&rank=3

Evaluating Intra-articular Injection of Axolotl Ambient Compared ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.