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Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects With Ankle Osteoarthritis (Phoenix)

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ClinicalTrials.gov Identifier: NCT05092646
Recruitment Status : Not yet recruiting
First Posted : October 25, 2021
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Axolotl Biologix

Brief Summary:
A Double-blind, Multi-Center, Prospective, Randomized Placebo-controlled Pilot Study Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects with Ankle Osteoarthritis. The goal of this pilot study and subsequent pivotal trial is to evaluate the safety and effectiveness of Axolotl Ambient intra-articular injection for ameliorating the pain and dysfunction associated with ankle OA.

Condition or disease Intervention/treatment Phase
Ankle Osteoarthritis Biological: Axolotl Ambient Drug: "Drug/Placebo: 0.9% Normal Saline" Phase 1 Phase 2

Detailed Description:
This pilot study is a double-blind multi-center, prospective, randomized, placebo-controlled trial. Upon randomization, patients will receive 1 intraarticular injection of the investigational product or control fluid. Follow-up will be conducted at 4 weeks, 3 and 6 months, with 6 months serving as the primary endpoint. 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 be monitored for an additional 6 months to establish safety over a 1-year follow-up and evaluate the durability of benefit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Placebo-controlled, Double-blinded
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Subjects, investigators, and outcome assessors will be blinded to the treatment allocation until completion of the 6-month follow-up visit.
Primary Purpose: Treatment
Official Title: A Double-blind, Multi-Center, Prospective, Randomized Placebo-controlled Pilot Study Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects With Ankle Osteoarthritis
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Placebo Comparator: Control Group
Single dose, 2.0 mL of 0.9% normal saline, administered via intra-articular injection administered to the affected tibiotalar joint.
Drug: "Drug/Placebo: 0.9% Normal Saline"
"Drug/Placebo: 0.9% Normal Saline"

Experimental: Investigational Group

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

Biological: Axolotl Ambient
Axolotl Ambient is an allogeneic amniotic intra-articular injection therapy consisting of a growth factor and cytokine-rich fluid derived from human amnion cells.
Other Name: CA20




Primary Outcome Measures :
  1. Proportion of patients achieving Composite Clinical Success [ Time Frame: 4 Weeks ]

    Changes from baseline to each follow-up timepoint (4 weeks, 3 and 6 months) will be calculated for each outcome metric and statistical significance of changes will be assessed through repeated measures ANOVA or a mixed effects model to accommodate missing data points. Two options (based on either AOS or FAOS scores) for CCS will be defined as:

    • Improvement in AOS (Pain and Function, independently) or FAOS (Pain and ADL, independently) subdomain scores of at least 20% from baseline

    AND

    • No medical or surgical intervention beyond allowed rescue medication

    AND

    • Absence of treatment-related SAEs

  2. Proportion of patients achieving Composite Clinical Success [ Time Frame: 3 Months ]

    Changes from baseline to each follow-up timepoint (4 weeks, 3 and 6 months) will be calculated for each outcome metric and statistical significance of changes will be assessed through repeated measures ANOVA or a mixed effects model to accommodate missing data points. Two options (based on either AOS or FAOS scores) for CCS will be defined as:

    • Improvement in AOS (Pain and Function, independently) or FAOS (Pain and ADL, independently) subdomain scores of at least 20% from baseline

    AND

    • No medical or surgical intervention beyond allowed rescue medication

    AND

    • Absence of treatment-related SAEs

  3. Proportion of patients achieving Composite Clinical Success [ Time Frame: 6 Months ]

    Changes from baseline to each follow-up timepoint (4 weeks, 3 and 6 months) will be calculated for each outcome metric and statistical significance of changes will be assessed through repeated measures ANOVA or a mixed effects model to accommodate missing data points. Two options (based on either AOS or FAOS scores) for CCS will be defined as:

    • Improvement in AOS (Pain and Function, independently) or FAOS (Pain and ADL, independently) subdomain scores of at least 20% from baseline

    AND

    • No medical or surgical intervention beyond allowed rescue medication

    AND

    • Absence of treatment-related SAEs


Secondary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Baseline (Day 0) to 12 Months ]
    An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in study subjects whether or not considered related to the investigational product. This definition includes events related to the investigational product or the comparator and events related to the procedures involved.

  2. Symptoms, Quality of Life and Sports and Recreation subscales of the FAOS [ Time Frame: Baseline (Day 0), 4 Weeks, 3 Months, 6 Months, and 12 Months ]
    The FAOS score was developed to reflect a foot and ankle version of the Knee Osteoarthritis Outcomes Score (KOOS). The FAOS score includes symptoms, quality of life and sports and recreation subscales.

  3. Visual Analog Scale for average ankle pain and worst ankle pain [ Time Frame: Baseline (Day 0), 4 Weeks, 3 Months, 6 Months, and 12 Months ]
    The Visual Analog Scale (VAS) is a measure of pain intensity. It is a continuous scale comprised of a horizontal visual analog scale anchored by two verbal descriptors (one for each symptom extreme).

  4. EuroQOL-5 dimension-5 level quality of life scale [ Time Frame: Baseline (Day 0), 4 Weeks, 3 Months, 6 Months, and 12 Months ]
    EQ-5D-5L is a self-completed health status questionnaire that assesses quality of life.

  5. Pain Catastrophizing Scale [ Time Frame: Baseline (Day 0), 4 Weeks, 3 Months, 6 Months, and 12 Months ]
    The pain catastrophizing scale (PCS) is a 13-item questionnaire that asks participants to grade each item on a 5-point scale.

  6. Current Working Status [ Time Frame: Baseline (Day 0), 4 Weeks, 3 Months, 6 Months, and 12 Months ]

    Percent of subject responses, for each of the following work status categories, by the treatment and control groups, at each timepoint.

    Current Working status, at each timepoint will be collected as:

    Not working, unrelated to ankle

    Not working, related to ankle

    Working with major limitations related to ankle

    Working without limitations related to ankle


  7. Modified Kellgren and Lawrence Grade [ Time Frame: Baseline (Day 0), 6 Months ]
    The modified Kellgren and Lawrence Grade (K-L Grade) classifies osteoarthritis using five grades based on evaluation of x-ray of the affected joint.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed written informed consent
  2. Willing to be randomized to either the investigational or control group
  3. Male or female at least 18 years of age and less than 80
  4. Clinical diagnosis of symptomatic tibiotalar (ankle) OA (primary idiopathic OA or post-traumatic OA), modified K-L grade 1-3a
  5. One ankle is the most symptomatic lower extremity joint and the only lower extremity joint currently planned for treatment
  6. Willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations
  7. For women of childbearing potential (not post-menopausal for 12 months or surgically sterile), a urine pregnancy test with a negative result must be obtained at screening and on the day of procedure, prior to injection
  8. 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
  9. Chronic ankle pain for ≥ 6 months
  10. SAOS Pain score ≥ 30 and ≤ 80 and AOS Function score ≥ 30 and ≤ 80
  11. Willing to discontinue all prescription and over-the-counter pain medications being used for ankle OA symptoms for the duration of the study, except for acetaminophen, which is not allowed for the 3 days preceding each scheduled follow-up visit and the day of the follow-up visit.

Exclusion Criteria:

  1. Previously received intra-articular injections in the index joint of Axolotl Ambient, bone marrow aspirate concentrate (BMAC), platelet-rich plasma (PRP), or other biologic-based products within the last 12 months.
  2. Modified K-L Grade 3b or 4 osteoarthritis of the index joint
  3. Diagnosis of ipsilateral peri-articular arthritis (e.g. subtalar joint) that the investigator determines may significantly confound the study results
  4. Received intra-articular hyaluronic acid injection in the index joint within the last 6 months
  5. Received intra-articular steroid injection in the index joint within the last 3 months
  6. Prior major surgical repair or reconstruction of the ankle that the investigator determines may significantly confound the study results
  7. Baseline pain catastrophizing score ≥ 23
  8. Any surgery of the index ankle within the last 12 months
  9. Planned arthroscopy or other procedure on the ankle during the study
  10. Bilateral ankle OA requiring treatment of both ankles
  11. Pregnancy, breastfeeding, or woman of child-bearing potential not using adequate contraception
  12. Bone deficit
  13. Charcot foot disease
  14. Radiographic evidence of open epiphyses
  15. Systemic inflammatory condition
  16. Substantial vascular insufficiency
  17. Current treatment with anticoagulants
  18. Deformity in coronal, axial or sagittal plane greater the 30°
  19. Patients weighing less than 47 kg.
  20. BMI greater than 45 kg/m2
  21. Documented medical history of, or radiographic evidence of, a bone disease (e.g. severe osteoporosis or avascular necrosis) or other condition (e.g., osteolysis)
  22. Comorbidity that would limit the ability to administer any functional measurements
  23. Has at the time of injection, a systemic or local infection at the site of injection
  24. Medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation (e.g., history of transient ischemic attack, stroke or liver disease)
  25. Known hypersensitivity to penicillin
  26. Known allergy to phenol red
  27. Currently receiving treatment with a drug known to interfere with bone or cartilage metabolism [e.g., systemic steroid therapy (topical steroid therapy is permissible), methotrexate]
  28. Medical condition requiring radiation, chemotherapy or immunosuppression
  29. Have an active history of malignancy (except for basal cell carcinoma of the skin)
  30. Has a history of autoimmune disease known to affect bone or cartilage. Examples include spondyloarthropathies (e.g., ankylosing spondylitis, Crohn's disease, and ulcerative colitis), Juvenile Arthritis, rheumatoid arthritis, Grave's disease, and Hashimoto's thyroiditis
  31. Has obvious or documented alcohol or illicit drug addictions
  32. Is a prisoner in a correctional institution/facility
  33. Actively involved in litigation or workman's compensation
  34. Has participated in clinical studies evaluating investigational devices, pharmaceuticals or biologics within 6 months of randomization
  35. Bedridden, confined to a wheelchair, or unable to walk 50 m without the help of a walker, crutches, or cane
  36. Is currently taking prescription pain medication for any conditions other than ankle osteoarthritis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05092646


Contacts
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Contact: Rena Mandino 3523593581 rmandino@telospartnersllc.com
Contact: Aaron J. Tabor, PhD 6027259505 atabor@axobio.com

Sponsors and Collaborators
Axolotl Biologix
Investigators
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Principal Investigator: Robert S. Kellar, PhD Chief Science Officer (CSO) Contact: rskellar@axobio.com Phone: 928-600-6608
Study Director: Aaron J. Tabor, PhD V.P. of Clinical Operations
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Responsible Party: Axolotl Biologix
ClinicalTrials.gov Identifier: NCT05092646    
Other Study ID Numbers: CA-2021-01
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axolotl Biologix:
Osteoarthritis, Biologic, Amniotic Fluid
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases