TTAX03 for the Treatment of Lumbosacral Facet Joint Pain

NCT06236308 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: TTAX03-CR007
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. The design is randomized, double blinded, placebo controlled and dose-group sequential.

Conditions

Facet Joint Pain

Outcome Measures

Primary Outcomes (1)

• 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

  12-weeks post baseline

Secondary Outcomes (6)

• NRS pain score

  At the end of 12, 26, 39, and 52 weeks following treatment, compared to placebo

• PROMIS-29

  At the end of 12, 26, 39, and 52 weeks following treatment, compared to placebo

• NRS pain score

  At the end of 1, 4, 8, and 12 weeks following treatment, compared to placebo

• PROMIS-29

  At the end of 12, 26, 39 and 52 weeks, compared to placebo

• ODI score

  At the end of 12, 26, 39 and 52 weeks, compared to placebo

Other Outcomes (1)

• Frequency and amount of narcotic use, radiofrequency ablation and surgical intervention

  Following treatment with TTAX03 or placebo after 12 weeks

Study Arms (3)

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).

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.

Biological: TTAX03 25mg

Saline Control

PLACEBO COMPARATOR

0.5 mL of saline alone

Biological: Placebo Comparator: Control Saline

Interventions

TTAX03 10mg BIOLOGICAL

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 10mg

TTAX03 25mg BIOLOGICAL

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 25mg

Placebo Comparator: Control Saline BIOLOGICAL

2 mL Sterile, preservative free 0.9% NaCl

Saline Control

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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
• e. 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

Sponsors & Collaborators

• BioTissue Holdings, Inc: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: February 1, 2024
• Study Start: July 15, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 4, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03