TerminatedNCT05092646PhoenixUpdated Aug 7, 2026Results posted

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

A Phase 1/2 interventional study of Axolotl Ambient and "Drug/Placebo: 0.9% Normal Saline" in Ankle Osteoarthritis, sponsored by Axolotl Biologix. Terminated at 3 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Axolotl Biologix · Phase 1/2, Interventional, and Treatment

Why this study was terminated

This study was terminated by the Sponsor in December 2023 due to business considerations.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Ankle Osteoarthritis

Browse trials for

Osteoarthritis 2,974

Keywords

Osteoarthritis, Biologic, Amniotic Fluid

In context

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

This study's enrollment of 12 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Axolotl Biologix is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Signed written
Willing to be randomized to either the 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 (not 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 (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.

Exclusion criteria

Exclusion Criteria:

Previously received intra-articular injections in the index joint of Axolotl Ambient, bone marrow aspirate concentrate (BMAC), -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 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 not using adequate
Bone deficit
Charcot foot disease
Radiographic evidence of open epiphyses
Systemic inflammatory condition
Substantial vascular insufficiency
Current treatment with anticoagulants
Deformity in coronal, axial or sagittal plane greater the 30°
Patients weighing less than 47 kg.
greater than 45 kg/m2
Documented medical history of, or radiographic evidence of, a bone disease (e.g. severe osteoporosis or avascular necrosis) or other condition (e.g., osteolysis)
Comorbidity that would limit the ability to administer any functional measurements
Has at the time of injection, a systemic or local infection at the site of injection
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 , stroke or liver disease)
Known to penicillin
Known allergy to phenol red
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]
Medical condition requiring radiation, chemotherapy or
Have an active history of (except for basal cell carcinoma of the skin)
Has a history of 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
Has obvious or documented alcohol or illicit drug addictions
Is a prisoner in a correctional institution/facility
Actively involved in litigation or workman's compensation
Has participated in clinical studies evaluating devices, pharmaceuticals or biologics within 6 months of randomization
Bedridden, confined to a wheelchair, or unable to walk 50 m without the help of a walker, crutches, or cane
Is currently taking prescription pain medication for any conditions other than ankle osteoarthritis.

Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 12 participants (actual)

Study arms

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"
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

Interventions

BiologicalAxolotl 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.
Also known as: CA20
Drug"Drug/Placebo: 0.9% Normal Saline"
"Drug/Placebo: 0.9% Normal Saline"

What researchers measure

Primary outcomes

Change From Baseline in Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Pain Subscale
The Ankle Osteoarthritis Scale (AOS) pain subscale goes from 0 (No pain) -100 (The worst imaginable).
Time frame: 4-weeks, 3-months, and 6-months
Change From Baseline for Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Function Subscale
The Ankle Osteoarthritis Scale (AOS) functions subscale goes from 0 (No difficulty) -100 (So difficult, unable).
Time frame: 4-week, 3 Months, 6-months
Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Pain Subscale
A score of 100 represents no pain. A score of 0 constant pain.
Time frame: 4-weeks, 3-months, 6-months
Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Function Subscale
100 represents perfect health and 0 represents extreme problems and complete functional limitation. .
Time frame: 4-weeks, 3-months, 6-months
Proportion of Patients Achieving Composite Clinical Success (CCS).
CCS defined as a patient meeting all of the three following criteria: 1. Improvement in AOS (Pain and Function) or FAOS scores (Pain and ADL) of at least 20% from baseline 2. No surgical intervention or prescription pain medications for ankle OA 3. No treatment or procedure-related serious adverse events
Time frame: 4-weeks, 3-months, 6-months

Secondary outcomes

Incidence of Adverse Events
Proportion of subjects experiencing at least (1) adverse events.
Time frame: Post-procedure follow-up assessments: 4 weeks (+/-7days), 3 Months (+/- 14 days), 6 Months (+/- 30 days), 12 Months (+/- 60 days), and unscheduled visits (up to 19 months)
FAOS Subscales Quality of Life (QoL)
0 (most severe problems) to 100 (no problems/best possible qualify of life)
Time frame: 4-week, 3-month, 6-month
Visual Analog Scale (VAS) for Ankle Pain (Average During Last 48 Hours)
100 millimeter scale 0mm - No Pain and 100mm - Worst Imaginable Pain
Time frame: 4 weeks, 3-months, 6-months
VAS Ankle Pain (Worst During Last 48 Hours)
100 millimeter scale 0mm - No Pain and 100mm - Worst Imaginable Pain
Time frame: 4-weeks, 3-months, 6-months
EuroQOL-5 Dimension-5 Level (EQ-5D-5L) Quality of Life Scale
0 to 100 scale - 0 the worst health you can imagine to 100 the best health you can imagine.
Time frame: 4-weeks, 3-months, 6-months
Working Status
Not working, unrelated to ankle Not working, related to ankle Working with major limitations related to ankle Working without limitations related to ankle
Time frame: Baseline, 4-weeks, 3-months, 6-months
K-L Grade From Weightbearing X-ray at Baseline and 6 Months
Grade 2 Definite osteophytes with mild to moderate joint space narrowing; early radiographic OA Grade 3a Significant osteophytes and joint space narrowing, but greater than 50% of the joint space remains preserved Grade 3b Severe joint space narrowing with less than 50% remaining joint space, approaching end-stage disease but not completely bone-on-bone Grade 4 Near complete or complete loss of joint space with substantial deformity (end-stage OA)
Time frame: Baseline, 6-months

Results

Posted Aug 7, 2026

Participant flow

Participant flow — Overall Study
Milestone	Control Group	Investigational Group
Started	6	6
Completed	2	2
Not completed	4	4

Outcome measures

PrimaryChange From Baseline in Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Pain Subscale

The Ankle Osteoarthritis Scale (AOS) pain subscale goes from 0 (No pain) -100 (The worst imaginable).

Time frame:: 4-weeks, 3-months, and 6-months
Reported as:: Mean · score on a scale

Change From Baseline in Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Pain Subscale
score on a scale	Control Group	Investigational Group
4-weeks	-7.0 ± 24.08	-2.2 ± 23.32
3-months	-11.7 ± 31.97	19.3 ± 32.75
6-months	-4.5 ± 12.47	6.3 ± 16.26

PrimaryChange From Baseline for Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Function Subscale

The Ankle Osteoarthritis Scale (AOS) functions subscale goes from 0 (No difficulty) -100 (So difficult, unable).

Time frame:: 4-week, 3 Months, 6-months
Reported as:: Mean · score on a scale

Change From Baseline for Ankle Osteoarthritis Scale (AOS; 48 hr Recall) Function Subscale
score on a scale	Control Group	Investigational Group
4-weeks	-13.3 ± 23.55	-0.6 ± 23.51
3-months	-14.2 ± 19.05	12.3 ± 24.03
6-months	-7.3 ± 7.74	8.7 ± 21.08

PrimaryChange From Baseline for Foot and Ankle Outcome Score (FAOS) for Pain Subscale

A score of 100 represents no pain. A score of 0 constant pain.

Time frame:: 4-weeks, 3-months, 6-months
Reported as:: Mean · score on a scale

Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Pain Subscale
score on a scale	Control Group	Investigational Group
4-weeks	10.0 ± 15.97	5.8 ± 22.33
3-months	16.5 ± 14.60	-13.0 ± 20.42
6-months	8.8 ± 7.79	-6.3 ± 12.66

PrimaryChange From Baseline for Foot and Ankle Outcome Score (FAOS) for Function Subscale

100 represents perfect health and 0 represents extreme problems and complete functional limitation. .

Time frame:: 4-weeks, 3-months, 6-months
Reported as:: Mean · score on a scale

Change From Baseline for Foot and Ankle Outcome Score (FAOS) for Function Subscale
score on a scale	Control Group	Investigational Group
4-weeks	5.0 ± 8.69	2.8 ± 11.82
3-months	8.5 ± 7.92	-6.7 ± 10.97
6-months	4.7 ± 2.50	-3.3 ± 7.37

PrimaryProportion of Patients Achieving Composite Clinical Success (CCS).

CCS defined as a patient meeting all of the three following criteria: 1. Improvement in AOS (Pain and Function) or FAOS scores (Pain and ADL) of at least 20% from baseline 2. No surgical intervention or prescription pain medications for ankle OA 3. No treatment or procedure-related serious adverse events

Time frame:: 4-weeks, 3-months, 6-months
Reported as:: Count of participants · Participants

Proportion of Patients Achieving Composite Clinical Success (CCS).
Participants	Control Group	Investigational Group
4-weeks	3	1
3-months	3	1
6-months	2	0

SecondaryIncidence of Adverse Events

Proportion of subjects experiencing at least (1) adverse events.

Time frame:: Post-procedure follow-up assessments: 4 weeks (+/-7days), 3 Months (+/- 14 days), 6 Months (+/- 30 days), 12 Months (+/- 60 days), and unscheduled visits (up to 19 months)
Reported as:: Count of participants · Participants

Incidence of Adverse Events
Participants	Control Group	Investigational Group
Incidence of Adverse Events	5	2

SecondaryFAOS Subscales Quality of Life (QoL)

0 (most severe problems) to 100 (no problems/best possible qualify of life)

Time frame:: 4-week, 3-month, 6-month
Reported as:: Mean · score on a scale

FAOS Subscales Quality of Life (QoL)
score on a scale	Control Group	Investigational Group
4-weeks	12.5 ± 17.27	11.4 ± 38.62
3-months	14.5 ± 20.39	0.0 ± 13.00
6-months	9.0 ± 18.60	2.0 ± 3.46

SecondaryVisual Analog Scale (VAS) for Ankle Pain (Average During Last 48 Hours)

100 millimeter scale 0mm - No Pain and 100mm - Worst Imaginable Pain

Time frame:: 4 weeks, 3-months, 6-months
Reported as:: Mean · score on a scale

Visual Analog Scale (VAS) for Ankle Pain (Average During Last 48 Hours)
score on a scale	Control Group	Investigational Group
4-weeks	3.0 ± 43.69	-0.6 ± 33.47
3-months	-12.2 ± 40.91	26.0 ± 29.00
6-months	-15.3 ± 14.29	8.7 ± 15.82

SecondaryVAS Ankle Pain (Worst During Last 48 Hours)

100 millimeter scale 0mm - No Pain and 100mm - Worst Imaginable Pain

Time frame:: 4-weeks, 3-months, 6-months
Reported as:: Mean · score on a scale

VAS Ankle Pain (Worst During Last 48 Hours)
score on a scale	Control Group	Investigational Group
4-weeks	-4.2 ± 32.85	2.2 ± 38.80
3-months	-11.2 ± 39.21	35.3 ± 35.92
6-months	-13.7 ± 16.77	5.0 ± 10.00

SecondaryEuroQOL-5 Dimension-5 Level (EQ-5D-5L) Quality of Life Scale

0 to 100 scale - 0 the worst health you can imagine to 100 the best health you can imagine.

Time frame:: 4-weeks, 3-months, 6-months
Reported as:: Mean · score on a scale

EuroQOL-5 Dimension-5 Level (EQ-5D-5L) Quality of Life Scale
score on a scale	Control Group	Investigational Group
4-weeks	8.3 ± 13.94	-0.4 ± 21.87
3-months	-0.2 ± 20.74	-20.0 ± 21.79
6-months	-5.7 ± 29.14	-6.7 ± 7.64

SecondaryWorking Status

Not working, unrelated to ankle Not working, related to ankle Working with major limitations related to ankle Working without limitations related to ankle

Time frame:: Baseline, 4-weeks, 3-months, 6-months
Reported as:: Count of participants · Participants

Working Status
Participants	Control Group	Investigational Group
Baseline — Not working, unrelated to ankle	2	1
Baseline — Not working, related to ankle	1	0
Baseline — Working with major limitations related to ankle	0	1
Baseline — Working without limitations related to ankle	3	4
4-weeks — Not working, unrelated to ankle	1	1
4-weeks — Not working, related to ankle	0	0
4-weeks — Working with major limitations related to ankle	2	0
4-weeks — Working without limitations related to ankle	3	4
3months — Not working, unrelated to ankle	1	0
3months — Not working, related to ankle	0	0
3months — Working with major limitations related to ankle	2	1
3months — Working without limitations related to ankle	3	2
6months — Not working, unrelated to ankle	2	0
6months — Not working, related to ankle	0	0
6months — Working with major limitations related to ankle	2	1
6months — Working without limitations related to ankle	2	2

SecondaryK-L Grade From Weightbearing X-ray at Baseline and 6 Months

Grade 2 Definite osteophytes with mild to moderate joint space narrowing; early radiographic OA Grade 3a Significant osteophytes and joint space narrowing, but greater than 50% of the joint space remains preserved Grade 3b Severe joint space narrowing with less than 50% remaining joint space, approaching end-stage disease but not completely bone-on-bone Grade 4 Near complete or complete loss of joint space with substantial deformity (end-stage OA)

Time frame:: Baseline, 6-months
Reported as:: Count of participants · Participants

K-L Grade From Weightbearing X-ray at Baseline and 6 Months
Participants	Control Group	Investigational Group
baseline Day 0 — Grade 2 Definite osteophytes with mild to moderate joint space narrowing; early radiographic OA	4	2
baseline Day 0 — Grade 3a	1	3
baseline Day 0 — Grade 3b	1	0
baseline Day 0 — Grade 4	0	0
6 Month — Grade 2 Definite osteophytes with mild to moderate joint space narrowing; early radiographic OA	3	0
6 Month — Grade 3a	1	1
6 Month — Grade 3b	0	0
6 Month — Grade 4	0	0

Adverse events

Collected over 19 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Control Group	0/6 (0%)	0/6 (0%)	5/6 (83.3%)
Investigational Group	0/6 (0%)	0/6 (0%)	2/6 (33.3%)

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Control Group	Investigational Group
Back PainMusculoskeletal and connective tissue disorders	3/6	0/6
Foot and Ankle PainMusculoskeletal and connective tissue disorders	3/6	0/6
Hip PainMusculoskeletal and connective tissue disorders	2/6	0/6
Back InjuryMusculoskeletal and connective tissue disorders	0/6	1/6
Left Hip OsteoarthritisMusculoskeletal and connective tissue disorders	0/6	1/6
Muscle SpasmsMusculoskeletal and connective tissue disorders	1/6	0/6
Knee PainMusculoskeletal and connective tissue disorders	1/6	0/6
Foot NumbnessMusculoskeletal and connective tissue disorders	1/6	0/6
Wrist PainMusculoskeletal and connective tissue disorders	1/6	0/6
BronchitisRespiratory, thoracic and mediastinal disorders	1/6	0/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Control Group	Investigational Group	Total
<=18 years	0	0	0
Between 18 and 65 years	6	6	12
>=65 years	0	0	0

Sex/Gender, Customized
Sex/Gender, Customized(Participants)	Control Group	Investigational Group	Total
Male or Female	6	6	12

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Control Group	Investigational Group	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Control Group	Investigational Group	Total
United States	6	6	12

Study locations

3 sites

Injury Care Research
Boise, Idaho 83713, United States
Orthopedic Specialists of Louisiana
Shreveport, Louisiana 71101, United States
OrthoCarolina Foot and Ankle Institute
Charlotte, North Carolina 28207, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Apr 13, 2022

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2021 to primary completion in Nov 2023, 23 months.

Results were first posted in Aug 2026, 2 years 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 8, 2021
First posted: Oct 25, 2021
StartActual: Dec 1, 2021
Primary completionActual: Nov 10, 2023
CompletionActual: Nov 10, 2023
Results first posted: Aug 7, 2026
Last update: Aug 7, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05092646
Lead sponsor: Axolotl Biologix
Responsible party: Sponsor
First posted: Oct 25, 2021
Start date: Dec 1, 2021
Primary completion: Nov 10, 2023
Completion: Nov 10, 2023
Results posted: Aug 7, 2026
Last update: Aug 7, 2026

Study contacts

Robert S. Kellar, PhD

study director · Chief Science Officer (CSO)

Aaron J. Tabor, PhD, CTBS

study director · V.P. of Clinical Operations

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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