RecruitingOsteoarthritis of Facet Joint of Lumbar Spine
Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint
Eligible age
18–75 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: InGeneron, Inc.
You may qualify if…
- ✓ 1. Male and female subjects, between 18 and 75 years of age.
- ✓ 2. Have documented the diagnosis of facet joint osteoarthritis from L1 to S1 in the opinion of the investigator.
- ✓ 3. Have a documented diagnosis of symptomatic facet joint syndrome is defined as the following (subject must meet all the listed conditions):
- ✓ 1. Chronic low back pain for at least 6 months.
- ✓ 2. 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).
- ✓ 3. Have undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain.
- ✓ 4. Change from normal spine morphology at the symptomatic level as defined by Radiographic evaluation for Lumbar facet joint osteoarthritis.
- ✓ 5. The baseline pain score of at least 4 on a pain scale of 0-10, over 24 hours
You may not qualify if…
- ✕ 1. Female subjects who are pregnant or nursing, or women planning to become pregnant within 12 months following treatment.
- ✕ 2. 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.
- ✕ 3. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI \> 40)
- ✕ 4. 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:
- ✕ 1. Contrast medium (discography or other diagnostic injection)
- ✕ 2. NSAIDs
- ✕ 3. Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine)
- ✕ 4. Antibiotics
Where it's recruiting
Florida
Deerfield Beach
South Dakota
Sioux Falls
Source: ClinicalTrials.gov · NCT03513731 · last updated 2025-08-20