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

NCT05092646 | Terminated Phase 1 FDA Drug

• 1 other identifier: CA-2021-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Ankle Osteoarthritis

Keywords

Osteoarthritis, Biologic, Amniotic Fluid

Outcome Measures

Primary Outcomes (3)

• Proportion of patients achieving Composite Clinical Success

  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

  4 Weeks

• Proportion of patients achieving Composite Clinical Success

  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 Months

• Proportion of patients achieving Composite Clinical Success

  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

  6 Months

Secondary Outcomes (7)

• Incidence of Adverse Events

  Baseline (Day 0) to 12 Months

• Symptoms, Quality of Life and Sports and Recreation subscales of the FAOS

  Baseline (Day 0), 4 Weeks, 3 Months, 6 Months, and 12 Months

• Visual Analog Scale for average ankle pain and worst ankle pain

  Baseline (Day 0), 4 Weeks, 3 Months, 6 Months, and 12 Months

• EuroQOL-5 dimension-5 level quality of life scale

  Baseline (Day 0), 4 Weeks, 3 Months, 6 Months, and 12 Months

• Pain Catastrophizing Scale

  Baseline (Day 0), 4 Weeks, 3 Months, 6 Months, and 12 Months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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"

Investigational Group

EXPERIMENTAL

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

Interventions

Axolotl Ambient BIOLOGICAL

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

Also known as: CA20

Investigational Group

"Drug/Placebo: 0.9% Normal Saline" DRUG

"Drug/Placebo: 0.9% Normal Saline"

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Willing to be randomized to either the investigational or control group
• Male or female at least 18 years of age and less than 80
• Clinical diagnosis of symptomatic tibiotalar (ankle) OA (primary idiopathic OA or post-traumatic OA), modified K-L grade 1-3a
• One ankle is the most symptomatic lower extremity joint and the only lower extremity joint currently planned for treatment
• Willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations
• 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
• 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
• Chronic ankle pain for ≥ 6 months
• SAOS Pain score ≥ 30 and ≤ 80 and AOS Function score ≥ 30 and ≤ 80
• 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.

You may not qualify if:

• 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.
• Modified K-L Grade 3b or 4 osteoarthritis of the index joint
• Diagnosis of ipsilateral peri-articular arthritis (e.g. subtalar joint) that the investigator determines may significantly confound the study results
• Received intra-articular hyaluronic acid injection in the index joint within the last 6 months
• Received intra-articular steroid injection in the index joint within the last 3 months
• Prior major surgical repair or reconstruction of the ankle that the investigator determines may significantly confound the study results
• Baseline pain catastrophizing score ≥ 23
• Any surgery of the index ankle within the last 12 months
• Planned arthroscopy or other procedure on the ankle during the study
• Bilateral ankle OA requiring treatment of both ankles
• Pregnancy, breastfeeding, or woman of child-bearing potential not using adequate contraception
• Bone deficit
• Charcot foot disease
• Radiographic evidence of open epiphyses
• Systemic inflammatory condition

Sponsors & Collaborators

• Axolotl Biologix: lead

Study Sites (3)

Injury Care Research

Boise, Idaho, 83713, United States

Location

Orthopedic Specialists of Louisiana

Shreveport, Louisiana, 71101, United States

Location

OrthoCarolina Foot and Ankle Institute

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Robert S. Kellar, PhD

  Chief Science Officer (CSO)

  STUDY DIRECTOR

• Aaron J. Tabor, PhD, CTBS

  V.P. of Clinical Operations

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, investigators, and outcome assessors will be blinded to the treatment allocation until completion of the 6-month follow-up visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Placebo-controlled, Double-blinded

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 25, 2021
• Study Start: December 1, 2021
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)