Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint

Recruiting now · Not applicable

Conditions studied: Osteoarthritis of Facet Joint of Lumbar Spine

In brief

This is a prospective, randomized, active controlled, single site safety and efficacy study in subjects suffering from chronic lumber back pain due to facet joint osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the facet joint.

Key facts

Study ID

NCT03513731

Run by

InGeneron, Inc.

People needed

40

Starts

2018-12-07

Expected to finish

2026-04-01

Last updated by the study team

2025-08-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects, between 18 and 75 years of age.
• Have documented the diagnosis of facet joint osteoarthritis from L1 to S1 in the opinion of the investigator.
• Have a documented diagnosis of symptomatic facet joint syndrome is defined as the following (subject must meet all the listed conditions):
• Chronic low back pain for at least 6 months.
• Have failed 3 months of conservative back pain care. (Conservative treatment regimens may include any or all of the following: initial rest, medications [e.g., anti-inflammatory, analgesics, narcotics/opioids, muscle relaxants], massage, acupuncture, chiropractic manipulations, activity modification, home-directed lumbar exercise program, and non- invasive pain control treatments or procedures).
• Have undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain.
• Change from normal spine morphology at the symptomatic level as defined by Radiographic evaluation for Lumbar facet joint osteoarthritis.
• The baseline pain score of at least 4 on a pain scale of 0-10, over 24 hours
• Subjects demonstrate >80% relief of their pain after diagnostic injection.
• Signed informed consent indicating the subject is willing to undergo treatment and willing to be available for each examination scheduled over the study duration

You may not qualify if…

• Female subjects who are pregnant or nursing, or women planning to become pregnant within 12 months following treatment.
• Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least one months prior to study entry.
• Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
• Any lumbar intradiscal injection, including steroids, at the symptomatic or adjacent discs less than 3 months prior to treatment injection, except for the following injections performed at least 2 weeks prior to study treatment:
• Contrast medium (discography or other diagnostic injection)
• NSAIDs
• Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine)
• Antibiotics
• Saline
• Epidural steroid injections, prior lumbar facet joint injection, medial branch block or radiofrequency ablation of facet joint nerves within 8 weeks prior to treatment injection.
• Have received chronic (more than 7 consecutive days) treatment with systemic corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to an injection procedure.
• Active malignancy or tumor as a source of symptoms or history of malignancy within the 2 years prior to enrollment on the study, except history of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or squamous cell carcinoma of the cervix if fully excised and with clear margins.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the target intervertebral disc or facet joint.
• An average baseline morphine equivalent dose (MED) of >40mg/day collected during the screening visit.
• Are at a higher risk, in the opinion of the investigator, for bleeding (e.g., bleeding disorder, or taking anticoagulants, except low dose aspirin) or infection (e.g., taking immunosuppressants, have a severe infection, or a history of serious infection).
• Current infection or prior history of spinal infection at the symptomatic level (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
• Severe and/or chronic pain conditions that may potentially confound facet joint symptom assessment, in the opinion of the investigator.
• Cauda equina syndrome.
• Receiving workman's compensation unless litigation is complete.
• Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
• Subjects with documented history of alcohol or drug abuse within the last year.
• Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of patient reported outcome instruments.
• Body habitus precluding adequate fluoroscopic visualization for the procedure or the procedure is physically impossible due to inability to inject the facet joint.
• Failed any component of the lumbar neurological exam at baseline (i.e., motor, sensory, or a reflex portion of the exam).

Where it is running

• Sports and Orthopedic Center — Deerfield Beach, Florida, United States (enrolling)
• Sanford Physical Medicine & Rehabilitation Clinic and Sanford Spine Center — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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