Facet Joint PainPhase 1NCT06236308
TTAX03 for the Treatment of Lumbosacral Facet Joint Pain
A Phase 1 study testing TTAX03 10mg and TTAX03 25mg in people with Facet Joint Pain, run by BioTissue Holdings, Inc.
Trial summary
This is a pilot study examining the safety and efficacy of a single intra-articular (IA) injection of TTAX03 per joint to relieve severe spinal facet joint (FJ) pain and improve function in subjects with facet joint pain (FJP) in the lumbosacral region. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Facet Joint Pain
- What is being tested?
- TTAX03 10mg and TTAX03 25mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 4 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent
- Women of childbearing potential (those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral oophorectomy], or not post-menopausal) may participate in the study if they meet all of the following conditions:
- they are not breast feeding
- they have a negative serum pregnancy test at screening
- they agree to undertake a serum pregnancy test at screening, at 3 months, and upon exiting the study
- they do not intend to become pregnant during the study
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- they are using adequate birth control methods and they agree to continue using those methods for the duration of the study
- Adequate birth control methods are defined as: hormonal-topical, oral, implantable or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or, surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use an adequate birth control method as described above for the remainder of the study.
- NOTE: Women who have had a bilateral tubal ligation are not considered to have been surgically sterilized and must agree to the conditions as specified above.
- Post-menopausal is defined as no menstrual period for at least one year.
- ≥ 35 and ≤ 85 years of age
- BMI <40 kg/m2
- Clinical suspicion of painful OA of the facet joint(s) in 1 to 4 lumbosacral joints (within 1 - 2 levels) of greater than 3 months duration.
- Evidence of OA of the facet in the lumbosacral region on MRI or X-ray within 3 months (e.g., joint space narrowing, the presence of osteophytes and/or subchondral cysts, articular process hypertrophy, subchondral bone sclerosis, articular and subarticular erosions).
- NRS score for "worst pain in the past 24 hrs" ≥ 5, using the first NRS value collected in the screening period.
- History of having attempted a regimen of conservative care, including physical therapy for ≥ 3 months.
- Positive response to two diagnostic MBB, defined as ≥ 80% reduction in pain, at any time within 1 hour, assessed at 1 hour, as self-reported by the subject, following each diagnostic block.
- White blood count ≥ 4,500 /uL, absolute neutrophil count (ANC) > 1,000 / uL, platelet count ≥ 75,000 /uL, Hgb ≥ 10 g/dL
- Normal prothrombin time (PT) and partial thromboplastin time (PTT).
- Hemoglobin A1c (HbA1c) ≤ 8%
- Adequate hepatic function (AST/ALT ≤ 1.5 × ULN, total bilirubin ≤ 1.2 × ULN)
- Adequate renal function (eGFR ≥ 60 mL/min/1.73 m2)
- Currently insufficient pain relief from acetaminophen, NSAIDs or other non-opioid analgesic medications.
Who cannot join
- Lactation or pregnancy
- Cardiovascular instability as indicated by any of the following identified at screening and verified at least once during the initial screening visit: uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic >100 mm Hg), uncontrolled arrhythmia or unstable angina pectoris.
- Cognitive impairment, mental illness, neuroses or untreated depression that would preclude understanding or reliably completing the patient reported outcome measures
- History within the past 12 months of gastrointestinal bleeding, myocardial infarction, chronic renal failure, hepatic fibrosis, chronic obstructive pulmonary disease, or hospitalization other than for elective procedures
- Non-ambulatory, bedridden, or with active fibromyalgia or central pain syndrome
- Hypoesthesia, paresthesia, or allodynia in either foot or leg
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- Facet OA pain involving more than two levels (i.e., > 4 FJs)
- Use of > 30 morphine milligram equivalents (MME) per day (see Study Guide)
- Score ≥ 21 on the Beck Depression Inventory (BDI)
- Allergy to any local anesthetic agents
- Any of the following conditions:
- Local (spine) or systemic infection
- Tumor in the spine
- Acute (< 3 months duration) vertebral fracture
- Systemic inflammatory disorder f. Radicular syndrome g. Cauda equina syndrome h. Ankylosing spondylitis i. Any arthritis not considered osteoarthritis, such as reactive, rheumatoid, psoriatic or enteropathic arthritis j. History of other autoimmune disease or Crohn's disease
- Progressive neurological condition such as Parkinson's, Alzheimer's, Lou Gehrig's disease, etc.
- Clinical characteristics suggestive of discogenic pain (i.e., chronic low back pain that subsides in supine position but aggravated after long-time sitting or standing, radicular pain)
- Radiologic evidence and radicular pain indicating symptomatic herniated disc
- Sacroiliac joint pain or symptomatic nerve root impingement (neurogenic claudication) related to spinal stenosis
- Evidence of dynamic listhesis, or fixed listhesis >10 mm accompanied by intermittent claudication or spinal stenosis
- Corticosteroid injections within 1 month of screening if injected into the lumbar spine remote from the index facet joints, or within 3 months of screening if injected into the index facet joints, or radiofrequency ablation treatment at any level in the lumbar spine within 6 months of screening for similar symptoms
- Prior surgery at the involved levels, including "failed back syndrome"
- History of spinal osteonecrosis, osteoporotic fracture, fracture around the index facet joint(s) within the past 3 years, or pars interarticularis defect
- Compensable disability or work injury, ongoing or anticipated litigation related to back injury
- Sickle cell disease
- Erythrocyte sedimentation rate (ESR) >40mm/hr
- Use of systemic immunosuppressive medications within past 6 months, including chronic systemic corticosteroids, chemotherapy, or history of organ transplant (kidney, heart, lung)
- Concurrent treatment, or treatment in the past 6 months, with any investigational agent
- Severe concurrent illness which, in the view of the investigator, would interfere with this 12-month study
About this study
Official title: A Randomized, Phase 1 Dose Finding Study of TTAX03 for the Treatment of Lumbosacral Facet Joint Pain
This is a pilot study examining the safety and efficacy of a single intra-articular (IA) injection of TTAX03 per joint to relieve severe spinal facet joint (FJ) pain and improve function in subjects with facet joint pain (FJP) in the lumbosacral region. The design is randomized, double blinded, placebo controlled and dose-group sequential.
Read the detailed description
This is a Phase 1, randomized, placebo-controlled, double-blinded dose ranging study design with two dose escalation cohorts to be conducted at three sites in the USA. The primary objective is to examine the safety of FJ IA injections with the test article. The fundamental framework for the number of subjects and dose escalation decisions is modeled on the widely utilized phase 1 "3+3" dose escalation design.
A second objective is to examine the efficacy of two doses of TTAX03. The efficacy null hypothesis (HO) is that one administration of TTAX03, introduced into each of two or four joints (at one or two levels) by IA injection, will have no more benefit with respect to pain relief and improved function than an equal volume of placebo (sterile saline). The alternate hypothesis (HA) is that TTAX03 will provide a clinically meaningful reduction in pain and improvement in function compared to placebo.
An exploratory objective is to examine the potential benefit in terms of reduced need for narcotic pain relief, radiofrequency ablation, or surgical procedures for relief of LBP.
- Conditions
- Facet Joint Pain
- Being tested
- TTAX03 10mg, TTAX03 25mg, Placebo Comparator: Control Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTAX03 10mgBiological
TTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic techniques followed by terminal sterilization by gamma-irradiation in compliance with Current Good Tissue Practices (CGTP) and Current Good Manufacturing Practices (CGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells.
TTAX03 25mgBiological
TTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic techniques followed by terminal sterilization by gamma-irradiation in compliance with Current Good Tissue Practices (CGTP) and Current Good Manufacturing Practices (CGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells.
Placebo Comparator: Control SalineBiological
2 mL Sterile, preservative free 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| TTAX03 10mg | Experimental | TTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic processing followed by terminal sterilization by gamma irradiation in compliance with current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells. 10 mg of TTAX03 in a 0.5 mL solution of sterile, preservative-free 0.9% NaCl (saline). Receives: Biological: TTAX03 10mg |
| TTAX03 25mg | Experimental | TTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic processing followed by terminal sterilization by gamma irradiation in compliance with current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells. 25 mg TTAX03 in a 0.5 mL saline solution; or 0.5 mL of saline alone. Receives: Biological: TTAX03 25mg |
| Saline Control | Placebo comparator | 0.5 mL of saline alone Receives: Biological: Placebo Comparator: Control Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical, functional and physiological responses to the intervention, as well as unanticipated events
Proportion of subjects with developing or worsening abnormalities on focused motor, sensory and reflex neurological exams;
- and - Changes from baseline in blood chemistries, hematology, serum immunoglobulins, urinalysis, and markers of inflammation
Measured: 12-weeks post baseline
Secondary outcomes (6)
NRS pain score
>/ 30% reduction in the NRS pain score
Measured: At the end of 12, 26, 39, and 52 weeks following treatment, compared to placebo
PROMIS-29
Improvement by >/ 5 points on the PROMIS-29
Measured: At the end of 12, 26, 39, and 52 weeks following treatment, compared to placebo
NRS pain score
Change from baseline in NRS value
Measured: At the end of 1, 4, 8, and 12 weeks following treatment, compared to placebo
PROMIS-29
Change from baseline in PROMIS-29
Measured: At the end of 12, 26, 39 and 52 weeks, compared to placebo
ODI score
Change from baseline in ODI score
Measured: At the end of 12, 26, 39 and 52 weeks, compared to placebo
PGIC
Change from baseline in PGIC
Measured: At the end of 12, 26, 39 and 52 weeks, compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start15 Jul 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion4 Mar 2025
Why it stopped: Study was stopped due to reprioritization for active studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTissue Holdings, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236308
- Sponsor's protocol ID
- TTAX03-CR007
- Status last verified
- Mar 2025
- First submitted
- 6 Nov 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 1 Dose Finding Study of TTAX03 for the Treatment of Lumbosacral Facet Joint Pain
- ClinicalTrials.gov ID
- NCT06236308
- Acronym / sponsor ID
- TTAX03-CR007
- Conditions
- Facet Joint Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was stopped due to reprioritization for active studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioTissue Holdings, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study examining the safety and efficacy of a single intra-articular (IA) injection of TTAX03 per joint to relieve severe spinal facet joint (FJ) pain and improve function in subjects with facet joint pain (FJP) in the lumbosacral region. The design is randomized, double blinded, placebo controlled and dose-group sequential.
Detailed description
This is a Phase 1, randomized, placebo-controlled, double-blinded dose ranging study design with two dose escalation cohorts to be conducted at three sites in the USA. The primary objective is to examine the safety of FJ IA injections with the test article. The fundamental framework for the number of subjects and dose escalation decisions is modeled on the widely utilized phase 1 "3+3" dose escalation design.
A second objective is to examine the efficacy of two doses of TTAX03. The efficacy null hypothesis (HO) is that one administration of TTAX03, introduced into each of two or four joints (at one or two levels) by IA injection, will have no more benefit with respect to pain relief and improved function than an equal volume of placebo (sterile saline). The alternate hypothesis (HA) is that TTAX03 will provide a clinically meaningful reduction in pain and improvement in function compared to placebo.
An exploratory objective is to examine the potential benefit in terms of reduced need for narcotic pain relief, radiofrequency ablation, or surgical procedures for relief of LBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TTAX03 10mg | Experimental | Biological: TTAX03 10mgTTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic processing followed by terminal sterilization by gamma irradiation in compliance with current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells. 10 mg of TTAX03 in a 0.5 mL solution of sterile, preservative-free 0.9% NaCl (saline). |
| TTAX03 25mg | Experimental | Biological: TTAX03 25mgTTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic processing followed by terminal sterilization by gamma irradiation in compliance with current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells. 25 mg TTAX03 in a 0.5 mL saline solution; or 0.5 mL of saline alone. |
| Saline Control | Placebo comparator | Biological: Placebo Comparator: Control Saline0.5 mL of saline alone |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Able and willing to provide written informed consent
- Women of childbearing potential (those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral oophorectomy], or not post-menopausal) may participate in the study if they meet all of the following conditions:
- Adequate birth control methods are defined as: hormonal-topical, oral, implantable or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or, surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use an adequate birth control method as described above for the remainder of the study.
- NOTE: Women who have had a bilateral tubal ligation are not considered to have been surgically sterilized and must agree to the conditions as specified above.
- Post-menopausal is defined as no menstrual period for at least one year.
Key exclusion criteria (29 listed)
- Lactation or pregnancy
- Cardiovascular instability as indicated by any of the following identified at screening and verified at least once during the initial screening visit: uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic >100 mm Hg), uncontrolled arrhythmia or unstable angina pectoris.
- Cognitive impairment, mental illness, neuroses or untreated depression that would preclude understanding or reliably completing the patient reported outcome measures
- History within the past 12 months of gastrointestinal bleeding, myocardial infarction, chronic renal failure, hepatic fibrosis, chronic obstructive pulmonary disease, or hospitalization other than for elective procedures
- Non-ambulatory, bedridden, or with active fibromyalgia or central pain syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTAX03 10mgTTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic techniques followed by terminal sterilization by gamma-irradiation in compliance with Current Good Tissue Practices (CGTP) and Current Good Manufacturing Practices (CGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells. | Biological | TTAX03 10mg |
| TTAX03 25mgTTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic techniques followed by terminal sterilization by gamma-irradiation in compliance with Current Good Tissue Practices (CGTP) and Current Good Manufacturing Practices (CGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells. | Biological | TTAX03 25mg |
| Placebo Comparator: Control Saline2 mL Sterile, preservative free 0.9% NaCl | Biological | Saline Control |
Primary outcome
Physical, functional and physiological responses to the intervention, as well as unanticipated events
Time frame: 12-weeks post baseline
Proportion of subjects with developing or worsening abnormalities on focused motor, sensory and reflex neurological exams; - and - Changes from baseline in blood chemistries, hematology, serum immunoglobulins, urinalysis, and markers of inflammation
6 secondary outcomes
NRS pain score
Time frame: At the end of 12, 26, 39, and 52 weeks following treatment, compared to placebo
PROMIS-29
Time frame: At the end of 12, 26, 39, and 52 weeks following treatment, compared to placebo
NRS pain score
Time frame: At the end of 1, 4, 8, and 12 weeks following treatment, compared to placebo
PROMIS-29
Time frame: At the end of 12, 26, 39 and 52 weeks, compared to placebo
ODI score
Time frame: At the end of 12, 26, 39 and 52 weeks, compared to placebo
PGIC
Time frame: At the end of 12, 26, 39 and 52 weeks, compared to placebo
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TTAX03 10mg and TTAX03 25mg in people with Facet Joint Pain, run by BioTissue Holdings, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical, functional and physiological responses to the intervention, as well as unanticipated events (time frame: 12-weeks post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.